MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'FDA MedWatch' source. Tue, 16 Mar 2010 13:40:54 +0100 http://www.medworm.com/index.php?rid=3366869&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204532.htm Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3366869 Tue, 16 Mar 2010 12:50:00 +0100 3366869 http://www.medworm.com/index.php?rid=3360205&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204256.htm Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3360205 Fri, 12 Mar 2010 20:00:00 +0100 3360205 http://www.medworm.com/index.php?rid=3360206&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204224.htm Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3360206 Fri, 12 Mar 2010 18:00:00 +0100 3360206 http://www.medworm.com/index.php?rid=3355453&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204177.htm Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3355453 Thu, 11 Mar 2010 20:45:00 +0100 3355453 http://www.medworm.com/index.php?rid=3355454&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204127.htm FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3355454 Thu, 11 Mar 2010 16:15:00 +0100 3355454 http://www.medworm.com/index.php?rid=3355455&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm204106.htm Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3355455 Thu, 11 Mar 2010 14:15:00 +0100 3355455 http://www.medworm.com/index.php?rid=3351411&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm203956.htm Device computer may shut down without an alarm, which can lead to serious injuries or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3351411 Wed, 10 Mar 2010 21:20:00 +0100 3351411 http://www.medworm.com/index.php?rid=3351412&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm203739.htm Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3351412 Wed, 10 Mar 2010 17:50:00 +0100 3351412 http://www.medworm.com/index.php?rid=3343358&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200138.htm UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010 (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3343358 Mon, 08 Mar 2010 19:15:00 +0100 3343358 http://www.medworm.com/index.php?rid=3336353&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm203272.htm Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3336353 Fri, 05 Mar 2010 17:20:00 +0100 3336353 http://www.medworm.com/index.php?rid=3328282&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm202885.htm Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3328282 Wed, 03 Mar 2010 16:55:00 +0100 3328282 http://www.medworm.com/index.php?rid=3312617&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm202254.htm Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3312617 Fri, 26 Feb 2010 22:05:00 +0100 3312617 http://www.medworm.com/index.php?rid=3343359&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm202169.htm Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3343359 Fri, 26 Feb 2010 19:05:00 +0100 3343359 http://www.medworm.com/index.php?rid=3312618&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm202169.htm Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3312618 Fri, 26 Feb 2010 19:05:00 +0100 3312618 http://www.medworm.com/index.php?rid=3299432&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm201563.htm Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir). (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3299432 Tue, 23 Feb 2010 18:32:00 +0100 3299432 http://www.medworm.com/index.php?rid=3295379&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm201446.htm FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3295379 Mon, 22 Feb 2010 20:00:00 +0100 3295379 http://www.medworm.com/index.php?rid=3291530&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm201108.htm Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3291530 Sat, 20 Feb 2010 21:15:00 +0100 3291530 http://www.medworm.com/index.php?rid=3284988&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm201003.htm FDA requires risk management plan and class-labeling changes for all LABAs. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3284988 Thu, 18 Feb 2010 20:20:00 +0100 3284988 http://www.medworm.com/index.php?rid=3284989&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200850.htm Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3284989 Thu, 18 Feb 2010 13:55:00 +0100 3284989 http://www.medworm.com/index.php?rid=3280889&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200672.htm Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3280889 Thu, 18 Feb 2010 00:30:00 +0100 3280889 http://www.medworm.com/index.php?rid=3277019&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200391.htm FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3277019 Tue, 16 Feb 2010 15:55:00 +0100 3277019 http://www.medworm.com/index.php?rid=3267767&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200137.htm Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3267767 Tue, 09 Feb 2010 23:00:00 +0100 3267767 http://www.medworm.com/index.php?rid=3267766&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm200138.htm Device may not be able to deliver therapy during a cardiac resuscitation attempt. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3267766 Tue, 09 Feb 2010 23:00:00 +0100 3267766 http://www.medworm.com/index.php?rid=3255714&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM200137 Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3255714 Tue, 09 Feb 2010 23:00:00 +0100 3255714 http://www.medworm.com/index.php?rid=3255713&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM200138 Device may not be able to deliver therapy during a cardiac resuscitation attempt. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3255713 Tue, 09 Feb 2010 23:00:00 +0100 3255713 http://www.medworm.com/index.php?rid=3267768&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm199965.htm Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3267768 Fri, 05 Feb 2010 16:00:00 +0100 3267768 http://www.medworm.com/index.php?rid=3245058&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM199927 Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245058 Thu, 04 Feb 2010 19:40:00 +0100 3245058 http://www.medworm.com/index.php?rid=3245059&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM198402 Clinicians should consider the potential long-term risks when prescribing to adolescents. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245059 Sat, 30 Jan 2010 03:20:00 +0100 3245059 http://www.medworm.com/index.php?rid=3245060&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM199343 Risk information added to Warnings/Precautions section and data summary provided (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245060 Fri, 29 Jan 2010 20:30:00 +0100 3245060 http://www.medworm.com/index.php?rid=3245061&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM199203 Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245061 Fri, 29 Jan 2010 18:35:00 +0100 3245061 http://www.medworm.com/index.php?rid=3217635&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm199203.htm Reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3217635 Fri, 29 Jan 2010 02:45:00 +0100 3217635 http://www.medworm.com/index.php?rid=3245062&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM199202 Plastic centrifuge rotor may crack, break apart and be forcefully ejected. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245062 Fri, 29 Jan 2010 02:15:00 +0100 3245062 http://www.medworm.com/index.php?rid=3245063&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM198728 Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245063 Tue, 26 Jan 2010 17:58:00 +0100 3245063 http://www.medworm.com/index.php?rid=3245064&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM198424 Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245064 Tue, 26 Jan 2010 16:00:00 +0100 3245064 http://www.medworm.com/index.php?rid=3245065&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM197862 UPDATE [01/23/2010] Previous alert updated with information on laboratory analysis of sibutramine levels in counterfeit product - Product sold over the internet contains controlled substance sibutramine. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245065 Sat, 23 Jan 2010 21:00:00 +0100 3245065 http://www.medworm.com/index.php?rid=3245066&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM198445 Needles may become detached and remain in the skin. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245066 Fri, 22 Jan 2010 19:00:00 +0100 3245066 http://www.medworm.com/index.php?rid=3198851&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm198445.htm Needles may become detached and remain in the skin. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3198851 Fri, 22 Jan 2010 19:00:00 +0100 3198851 http://www.medworm.com/index.php?rid=3245067&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM198221 Contraindication to use in patients with history of cardiovascular disease. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245067 Thu, 21 Jan 2010 16:00:00 +0100 3245067 http://www.medworm.com/index.php?rid=3182807&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm197862.htm Product sold over the internet contains controlled substance sibutramine. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3182807 Mon, 18 Jan 2010 15:50:00 +0100 3182807 http://www.medworm.com/index.php?rid=3245068&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM197834 Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245068 Sat, 16 Jan 2010 02:00:00 +0100 3245068 http://www.medworm.com/index.php?rid=3245069&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM197740 December 2009 recall expanded to multiple products. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245069 Fri, 15 Jan 2010 18:53:00 +0100 3245069 http://www.medworm.com/index.php?rid=3245070&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM195704 [UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009 (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245070 Fri, 15 Jan 2010 15:15:00 +0100 3245070 http://www.medworm.com/index.php?rid=3245071&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM197570 Selected varieties recalled due to packaging defect that could cause possible bacterial contamination. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245071 Wed, 13 Jan 2010 23:55:00 +0100 3245071 http://www.medworm.com/index.php?rid=3245072&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM197059 Switching between assays for the same patient can produce differing results that may be clinically significant. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245072 Mon, 11 Jan 2010 17:15:00 +0100 3245072 http://www.medworm.com/index.php?rid=3245073&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM196266 Device may crack near the radiopaque marker band, potentially resulting in serious patient injury. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245073 Tue, 05 Jan 2010 18:35:00 +0100 3245073 http://www.medworm.com/index.php?rid=3143547&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm196266.htm Device may crack near the radiopaque marker band, potentially resulting in serious patient injury. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3143547 Tue, 05 Jan 2010 18:35:00 +0100 3143547 http://www.medworm.com/index.php?rid=3245074&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM196045 Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245074 Fri, 01 Jan 2010 01:30:00 +0100 3245074 http://www.medworm.com/index.php?rid=3124982&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm195704.htm Recall expanded from November recall of 5 lots due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009 (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3124982 Tue, 29 Dec 2009 02:00:00 +0100 3124982 http://www.medworm.com/index.php?rid=3245075&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM195703 FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245075 Mon, 28 Dec 2009 23:00:00 +0100 3245075 http://www.medworm.com/index.php?rid=3245076&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2FUCM188555 [UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3245076 Wed, 23 Dec 2009 20:00:00 +0100 3245076 http://www.medworm.com/index.php?rid=3097529&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm194585.htm Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3097529 Thu, 17 Dec 2009 17:03:00 +0100 3097529 http://www.medworm.com/index.php?rid=3090076&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm194091.htm Recall of products, sold as a dietary supplements, containing undeclared sulfoaildenafil, which may result in lowering of blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3090076 Tue, 15 Dec 2009 13:00:00 +0100 3090076 http://www.medworm.com/index.php?rid=3072531&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm193583.htm One lot recalled because labeling on the foil blister card of certain packages were printed with the label reversed, and consumers may not be aware of the warnings of an antihistamine that could cause drowsiness. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3072531 Wed, 09 Dec 2009 18:10:00 +0100 3072531 http://www.medworm.com/index.php?rid=3057711&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm193047.htm Cases of drug-induced hepatotoxicity reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3057711 Fri, 04 Dec 2009 22:30:00 +0100 3057711 http://www.medworm.com/index.php?rid=3053630&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm192842.htm Unapproved device with potential for improper sterilization and disinfection. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3053630 Fri, 04 Dec 2009 00:00:00 +0100 3053630 http://www.medworm.com/index.php?rid=3053631&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm192788.htm Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3053631 Thu, 03 Dec 2009 19:00:00 +0100 3053631 http://www.medworm.com/index.php?rid=3053632&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm192699.htm Potential association between Lexiva and myocardial infarction in HIV infected adults. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3053632 Thu, 03 Dec 2009 14:30:00 +0100 3053632 http://www.medworm.com/index.php?rid=3049476&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm192655.htm Risk of sudden death and cardiac dysrhythmias in patients being treated with Norpramin. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3049476 Wed, 02 Dec 2009 19:10:00 +0100 3049476 http://www.medworm.com/index.php?rid=3031516&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm192105.htm A potential for the navigation PC SPC-1 component to stop working which could result in potential harms associated with this failure. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3031516 Fri, 27 Nov 2009 11:00:00 +0100 3031516 http://www.medworm.com/index.php?rid=3013563&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm191655.htm FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3013563 Fri, 20 Nov 2009 23:00:00 +0100 3013563 http://www.medworm.com/index.php?rid=3009434&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm191471.htm Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3009434 Fri, 20 Nov 2009 01:00:00 +0100 3009434 http://www.medworm.com/index.php?rid=3009435&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm191413.htm Product found containing the bacteria B. cepacia. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3009435 Fri, 20 Nov 2009 00:50:00 +0100 3009435 http://www.medworm.com/index.php?rid=3005164&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm191052.htm Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3005164 Wed, 18 Nov 2009 13:30:00 +0100 3005164 http://www.medworm.com/index.php?rid=3001017&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190967.htm Nationwide recall due to stretching or fracture of the sheath during use. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3001017 Tue, 17 Nov 2009 19:45:00 +0100 3001017 http://www.medworm.com/index.php?rid=3001018&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190925.htm Five products marketed as dietary supplements contain undeclared substances considered to be steroids. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3001018 Tue, 17 Nov 2009 18:45:00 +0100 3001018 http://www.medworm.com/index.php?rid=3001019&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190848.htm Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=3001019 Tue, 17 Nov 2009 15:15:00 +0100 3001019 http://www.medworm.com/index.php?rid=2996584&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190704.htm Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2996584 Mon, 16 Nov 2009 16:15:00 +0100 2996584 http://www.medworm.com/index.php?rid=2990187&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190531.htm Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2990187 Fri, 13 Nov 2009 21:00:00 +0100 2990187 http://www.medworm.com/index.php?rid=2990188&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190496.htm Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2990188 Fri, 13 Nov 2009 18:50:00 +0100 2990188 http://www.medworm.com/index.php?rid=2990189&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190480.htm Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2990189 Fri, 13 Nov 2009 17:55:00 +0100 2990189 http://www.medworm.com/index.php?rid=2986047&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm190330.htm Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2986047 Thu, 12 Nov 2009 20:55:00 +0100 2986047 http://www.medworm.com/index.php?rid=2978530&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm189839.htm 14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2978530 Tue, 10 Nov 2009 19:50:00 +0100 2978530 http://www.medworm.com/index.php?rid=2974627&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm189650.htm Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2974627 Tue, 10 Nov 2009 03:15:00 +0100 2974627 http://www.medworm.com/index.php?rid=2974628&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm189589.htm Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2974628 Mon, 09 Nov 2009 19:50:00 +0100 2974628 http://www.medworm.com/index.php?rid=2964369&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm189300.htm Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2964369 Thu, 05 Nov 2009 19:30:00 +0100 2964369 http://www.medworm.com/index.php?rid=2974629&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188957.htm Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2974629 Wed, 04 Nov 2009 02:00:00 +0100 2974629 http://www.medworm.com/index.php?rid=2955882&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188957.htm Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2955882 Wed, 04 Nov 2009 02:00:00 +0100 2955882 http://www.medworm.com/index.php?rid=2951638&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188703.htm Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2951638 Mon, 02 Nov 2009 19:30:00 +0100 2951638 http://www.medworm.com/index.php?rid=2944801&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188562.htm Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2944801 Fri, 30 Oct 2009 21:30:00 +0100 2944801 http://www.medworm.com/index.php?rid=2944802&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188555.htm Nationwide recall due to stretching or fracture of the sheath during use. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2944802 Fri, 30 Oct 2009 04:00:00 +0100 2944802 http://www.medworm.com/index.php?rid=2932111&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm188151.htm Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2932111 Wed, 28 Oct 2009 01:15:00 +0100 2932111 http://www.medworm.com/index.php?rid=2924173&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm187814.htm Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2924173 Sat, 24 Oct 2009 20:30:00 +0100 2924173 http://www.medworm.com/index.php?rid=2921245&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm187791.htm Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2921245 Fri, 23 Oct 2009 20:00:00 +0100 2921245 http://www.medworm.com/index.php?rid=2913509&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm187481.htm Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2913509 Wed, 21 Oct 2009 17:00:00 +0100 2913509 http://www.medworm.com/index.php?rid=2905830&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm187117.htm Reports of sparking, charring, and fires from device power cords. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2905830 Mon, 19 Oct 2009 19:30:00 +0100 2905830 http://www.medworm.com/index.php?rid=2900071&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183714.htm UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2900071 Fri, 16 Oct 2009 21:20:00 +0100 2900071 http://www.medworm.com/index.php?rid=2900072&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm186899.htm Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2900072 Fri, 16 Oct 2009 14:30:00 +0100 2900072 http://www.medworm.com/index.php?rid=2877397&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm186081.htm Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2877397 Fri, 09 Oct 2009 21:00:00 +0100 2877397 http://www.medworm.com/index.php?rid=2877398&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm186105.htm Initial Notification of risk of radiation overexposures during CT brain perfusion scans. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2877398 Fri, 09 Oct 2009 14:00:00 +0100 2877398 http://www.medworm.com/index.php?rid=2870041&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm185702.htm Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2870041 Wed, 07 Oct 2009 17:30:00 +0100 2870041 http://www.medworm.com/index.php?rid=2859846&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm185179.htm Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2859846 Mon, 05 Oct 2009 15:45:00 +0100 2859846 http://www.medworm.com/index.php?rid=2853032&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm184742.htm Field removal of the catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2853032 Thu, 01 Oct 2009 21:00:00 +0100 2853032 http://www.medworm.com/index.php?rid=2853033&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm184687.htm The change will result in 10% reduction in the potency of the heparin marketed in the U.S. and may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2853033 Thu, 01 Oct 2009 20:00:00 +0100 2853033 http://www.medworm.com/index.php?rid=2839760&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm184129.htm Nationwide recall of Neocate Infant Specialized Formula, Lot # P91877, due to a manufacturing error that resulted in protein levels lower than that declared on the label. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2839760 Tue, 29 Sep 2009 14:55:00 +0100 2839760 http://www.medworm.com/index.php?rid=2833021&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183924.htm Voluntary recall because of potential manufacturing problems. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2833021 Sat, 26 Sep 2009 01:45:00 +0100 2833021 http://www.medworm.com/index.php?rid=2833022&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183840.htm Early Communication describing an increased number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2833022 Fri, 25 Sep 2009 18:00:00 +0100 2833022 http://www.medworm.com/index.php?rid=2829405&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183800.htm Cases of acute pancreatitis reported in patients treated with sitagliptin. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2829405 Fri, 25 Sep 2009 16:00:00 +0100 2829405 http://www.medworm.com/index.php?rid=2829406&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183753.htm Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009 (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2829406 Fri, 25 Sep 2009 02:30:00 +0100 2829406 http://www.medworm.com/index.php?rid=2829407&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm183714.htm Pharmacists and pediatrics healthcare profesionals notified of risk of medication dosing errors (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2829407 Thu, 24 Sep 2009 05:00:00 +0100 2829407 http://www.medworm.com/index.php?rid=2801807&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm182667.htm FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2801807 Thu, 17 Sep 2009 14:45:00 +0100 2801807 http://www.medworm.com/index.php?rid=2797910&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm182500.htm Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2797910 Wed, 16 Sep 2009 16:06:34 +0100 2797910 http://www.medworm.com/index.php?rid=2797911&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm182496.htm Class I recall due to failure or delay in delivery of therapy. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2797911 Wed, 16 Sep 2009 15:45:00 +0100 2797911 http://www.medworm.com/index.php?rid=2786997&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm182084.htm Nationwide recall due to risk of obstruction and inability to ventilate patient. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2786997 Fri, 11 Sep 2009 23:30:00 +0100 2786997 http://www.medworm.com/index.php?rid=2783247&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181878.htm Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2783247 Thu, 10 Sep 2009 19:30:00 +0100 2783247 http://www.medworm.com/index.php?rid=2783248&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181833.htm Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2783248 Thu, 10 Sep 2009 17:30:00 +0100 2783248 http://www.medworm.com/index.php?rid=2783249&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181772.htm Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2783249 Thu, 10 Sep 2009 14:25:00 +0100 2783249 http://www.medworm.com/index.php?rid=2779645&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181725.htm Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2779645 Wed, 09 Sep 2009 19:40:00 +0100 2779645 http://www.medworm.com/index.php?rid=2767134&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181505.htm Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2767134 Sat, 05 Sep 2009 02:30:00 +0100 2767134 http://www.medworm.com/index.php?rid=2763310&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm181306.htm Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2763310 Thu, 03 Sep 2009 18:15:00 +0100 2763310 http://www.medworm.com/index.php?rid=2738750&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm180579.htm Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2738750 Thu, 27 Aug 2009 21:00:00 +0100 2738750 http://www.medworm.com/index.php?rid=2727866&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm180025.htm FDA is reviewing reports of serious liver injury, including liver failure. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2727866 Mon, 24 Aug 2009 19:15:00 +0100 2727866 http://www.medworm.com/index.php?rid=2727867&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm179955.htm Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2727867 Mon, 24 Aug 2009 05:00:00 +0100 2727867 http://www.medworm.com/index.php?rid=2721292&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm179925.htm The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2721292 Fri, 21 Aug 2009 05:00:00 +0100 2721292 http://www.medworm.com/index.php?rid=2705897&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm179004.htm Potential risks from Hospira, Inc. power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2705897 Mon, 17 Aug 2009 05:00:00 +0100 2705897 http://www.medworm.com/index.php?rid=2700631&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm177434.htm Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2700631 Fri, 14 Aug 2009 17:45:00 +0100 2700631 http://www.medworm.com/index.php?rid=2700632&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm177397.htm Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2700632 Fri, 14 Aug 2009 15:30:00 +0100 2700632 http://www.medworm.com/index.php?rid=2696921&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm177295.htm GDH-PQQ Glucose Monitoring Technology - possibility of falsely elevated blood glucose results when using GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2696921 Thu, 13 Aug 2009 20:20:00 +0100 2696921 http://www.medworm.com/index.php?rid=2672468&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm174797.htm Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2672468 Wed, 05 Aug 2009 16:00:00 +0100 2672468 http://www.medworm.com/index.php?rid=2668706&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm175843.htm FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2668706 Tue, 04 Aug 2009 20:30:00 +0100 2668706 http://www.medworm.com/index.php?rid=2658739&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm174797.htm Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2658739 Fri, 31 Jul 2009 05:00:00 +0100 2658739 http://www.medworm.com/index.php?rid=2654870&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm174608.htm Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2654870 Thu, 30 Jul 2009 22:30:00 +0100 2654870 http://www.medworm.com/index.php?rid=2654871&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm174596.htm Two previously uncharacterized safety concerns associated with the use of colchicine. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2654871 Thu, 30 Jul 2009 22:10:00 +0100 2654871 http://www.medworm.com/index.php?rid=2650774&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm174339.htm Product recalled because samples were found to contain an undeclared drug ingredient, an analog of sildenafil. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2650774 Wed, 29 Jul 2009 05:00:00 +0100 2650774 http://www.medworm.com/index.php?rid=2646599&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm173983.htm Products are unapproved drugs and associated with serious risks of liver injury, stroke. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2646599 Tue, 28 Jul 2009 04:00:00 +0100 2646599 http://www.medworm.com/index.php?rid=2627633&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm173327.htm FDA analysis has found carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2627633 Wed, 22 Jul 2009 04:00:00 +0100 2627633 http://www.medworm.com/index.php?rid=2627632&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm173239.htm Nationwide recall due to potential risk of fire and burns for patient and caregiver (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2627632 Wed, 22 Jul 2009 04:00:00 +0100 2627632 http://www.medworm.com/index.php?rid=2614697&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172712.htm Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2614697 Sat, 18 Jul 2009 21:00:00 +0100 2614697 http://www.medworm.com/index.php?rid=2612075&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172507.htm Recall due to presence of elevated endotoxin levels in some vials. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2612075 Fri, 17 Jul 2009 14:15:00 +0100 2612075 http://www.medworm.com/index.php?rid=2612076&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172527.htm Products recalled due to an undeclared drug ingredient which may present a significant health risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/17/2009 (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2612076 Fri, 17 Jul 2009 04:00:00 +0100 2612076 http://www.medworm.com/index.php?rid=2607161&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172406.htm FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2607161 Thu, 16 Jul 2009 18:40:00 +0100 2607161 http://www.medworm.com/index.php?rid=2607162&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172312.htm Products recalled because samples were found to contain undeclared drug ingredients. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2607162 Thu, 16 Jul 2009 04:00:00 +0100 2607162 http://www.medworm.com/index.php?rid=2603428&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm172252.htm Nationwide voluntary recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 ounce (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2603428 Wed, 15 Jul 2009 04:00:00 +0100 2603428 http://www.medworm.com/index.php?rid=2599243&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm171828.htm FDA requiring manufacturers of immunosuppressant drugs to update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2599243 Tue, 14 Jul 2009 04:00:00 +0100 2599243 http://www.medworm.com/index.php?rid=2599242&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm171914.htm Product recalled because samples were found to contain undeclared Tadalalafil, an active ingredient of FDA approved drugs for Erectile Dysfunction. Tadalalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2599242 Tue, 14 Jul 2009 04:00:00 +0100 2599242 http://www.medworm.com/index.php?rid=2595164&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm171686.htm Nationwide recall because the affected infusion sets may not allow the insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin, potentially leading to serious injury or death. (Source: FDA MedWatch) FDA MedWatch organizations http://www.medworm.com/rss/comments.php?id=2595164 Mon, 13 Jul 2009 04:00:00 +0100 2595164