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Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety ReviewEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - November 20, 2009 Category: American Health Source Type: organizations

Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial CommunicationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - November 20, 2009 Category: American Health Source Type: organizations

Vicks Sinex Nasal Spray - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Product found containing the bacteria B. cepacia. (Source: FDA MedWatch)
Source: FDA MedWatch - November 20, 2009 Category: American Health Source Type: organizations

RockHard Weekend - product contains undeclared drug ingredientEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil. (Source: FDA MedWatch)
Source: FDA MedWatch - November 18, 2009 Category: American Health Source Type: organizations

Cardiovascular Systems ViperSheath Sheath Introducer - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nationwide recall due to stretching or fracture of the sheath during use. (Source: FDA MedWatch)
Source: FDA MedWatch - November 17, 2009 Category: American Health Source Type: organizations

IDS Sports Dietary Supplements - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Five products marketed as dietary supplements contain undeclared substances considered to be steroids. (Source: FDA MedWatch)
Source: FDA MedWatch - November 17, 2009 Category: American Health Source Type: organizations

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug InteractionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - November 17, 2009 Category: American Health Source Type: organizations

Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health NotificationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. (Source: FDA MedWatch)
Source: FDA MedWatch - November 16, 2009 Category: American Health Source Type: organizations

Pai You Guo, Marketed as Dietary Supplement - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein. (Source: FDA MedWatch)
Source: FDA MedWatch - November 13, 2009 Category: American Health Source Type: organizations

Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - ChondrolysisEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices. (Source: FDA MedWatch)
Source: FDA MedWatch - November 13, 2009 Category: American Health Source Type: organizations

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and ThyrogenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - November 13, 2009 Category: American Health Source Type: organizations

Synthes USA, Ti Synex II Vertebral Body Replacement - Class I RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - November 12, 2009 Category: American Health Source Type: organizations

External Biphasic Defibrillators Energy Levels: Initial CommunicationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient. (Source: FDA MedWatch)
Source: FDA MedWatch - November 10, 2009 Category: American Health Source Type: organizations

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. (Source: FDA MedWatch)
Source: FDA MedWatch - November 10, 2009 Category: American Health Source Type: organizations

Hospira Brand Propofol and Liposyn Products - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow. (Source: FDA MedWatch)
Source: FDA MedWatch - November 9, 2009 Category: American Health Source Type: organizations

Stiff Nights - product contains undeclared drug ingredientEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. (Source: FDA MedWatch)
Source: FDA MedWatch - November 5, 2009 Category: American Health Source Type: organizations

Dietary Supplements Sold on Internet by Bodybuilding.comEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. (Source: FDA MedWatch)
Source: FDA MedWatch - November 4, 2009 Category: American Health Source Type: organizations

Bodybuilding.com Brand Dietary Supplements - Sold on InternetEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. (Source: FDA MedWatch)
Source: FDA MedWatch - November 4, 2009 Category: American Health Source Type: organizations

Byetta (exenatide) - Renal FailureEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. (Source: FDA MedWatch)
Source: FDA MedWatch - November 2, 2009 Category: American Health Source Type: organizations

Pointe Scientific Liquid Glucose Hexokinase Reagent - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - October 30, 2009 Category: American Health Source Type: organizations

Cordis CROSSOVER Sheath Introducer - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nationwide recall due to stretching or fracture of the sheath during use. (Source: FDA MedWatch)
Source: FDA MedWatch - October 30, 2009 Category: American Health Source Type: organizations

Accusure Insulin Syringes (Qualitest Pharmaceuticals) - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. (Source: FDA MedWatch)
Source: FDA MedWatch - October 28, 2009 Category: American Health Source Type: organizations

Peramivir IVEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. (Source: FDA MedWatch)
Source: FDA MedWatch - October 24, 2009 Category: American Health Source Type: organizations

Rituxan (rituximab) - PMLEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - October 23, 2009 Category: American Health Source Type: organizations

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product. (Source: FDA MedWatch)
Source: FDA MedWatch - October 21, 2009 Category: American Health Source Type: organizations

Medical Device Power Cords Safety Investigation: Initial CommunicationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Reports of sparking, charring, and fires from device power cords. (Source: FDA MedWatch)
Source: FDA MedWatch - October 19, 2009 Category: American Health Source Type: organizations

Tamiflu (oseltamivir) for Oral SuspensionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet. (Source: FDA MedWatch)
Source: FDA MedWatch - October 16, 2009 Category: American Health Source Type: organizations

Dexferrum (iron dextran injection) - Labeling ChangeEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. (Source: FDA MedWatch)
Source: FDA MedWatch - October 16, 2009 Category: American Health Source Type: organizations

Relenza (zanamivir) Inhalation PowderEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator. (Source: FDA MedWatch)
Source: FDA MedWatch - October 9, 2009 Category: American Health Source Type: organizations

CT Brain Perfusion Scans Safety Investigation: Initial NotificationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Initial Notification of risk of radiation overexposures during CT brain perfusion scans. (Source: FDA MedWatch)
Source: FDA MedWatch - October 9, 2009 Category: American Health Source Type: organizations

Unomedical Manual Pulmonary Resuscitator - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly. (Source: FDA MedWatch)
Source: FDA MedWatch - October 7, 2009 Category: American Health Source Type: organizations

Philips Heartstart Fr2+ Automated External Defibrillators - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - October 5, 2009 Category: American Health Source Type: organizations

Neuron 6F 070 Delivery Catheter [Penumbra]Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - October 1, 2009 Category: American Health Source Type: organizations

Heparin: Change in Reference StandardEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - October 1, 2009 Category: American Health Source Type: organizations

Neocate Infant Specialized Formula - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - September 29, 2009 Category: American Health Source Type: organizations

Children's and Infants' Tylenol Oral Suspension Products - RecallEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Voluntary recall because of potential manufacturing problems. (Source: FDA MedWatch)
Source: FDA MedWatch - September 26, 2009 Category: American Health Source Type: organizations

Exjade (deferasirox) - Early CommunicationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - September 25, 2009 Category: American Health Source Type: organizations

Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitisEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Cases of acute pancreatitis reported in patients treated with sitagliptin. (Source: FDA MedWatch)
Source: FDA MedWatch - September 25, 2009 Category: American Health Source Type: organizations

Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision KitEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009 (Source: FDA MedWatch)
Source: FDA MedWatch - September 25, 2009 Category: American Health Source Type: organizations

Tamiflu (oseltamivir) for Oral Suspension: Potential Medication ErrorsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Pharmacists and pediatrics healthcare profesionals notified of risk of medication dosing errors (Source: FDA MedWatch)
Source: FDA MedWatch - September 24, 2009 Category: American Health Source Type: organizations

Natalizumab (marketed as Tysabri)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. (Source: FDA MedWatch)
Source: FDA MedWatch - September 17, 2009 Category: American Health Source Type: organizations

Promethazine Hydrochloride InjectionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine. (Source: FDA MedWatch)
Source: FDA MedWatch - September 16, 2009 Category: American Health Source Type: organizations

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Class I recall due to failure or delay in delivery of therapy. (Source: FDA MedWatch)
Source: FDA MedWatch - September 16, 2009 Category: American Health Source Type: organizations

Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nationwide recall due to risk of obstruction and inability to ventilate patient. (Source: FDA MedWatch)
Source: FDA MedWatch - September 11, 2009 Category: American Health Source Type: organizations

Covidien Pedi-Cap End-Tidal CO2 DetectorEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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)
Source: FDA MedWatch - September 10, 2009 Category: American Health Source Type: organizations

ConMed Linvatec - Universal Cables and Power Pro HandpiecesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff. (Source: FDA MedWatch)
Source: FDA MedWatch - September 10, 2009 Category: American Health Source Type: organizations

Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol. (Source: FDA MedWatch)
Source: FDA MedWatch - September 10, 2009 Category: American Health Source Type: organizations

Penumbra Neuron 5F Select CatheterEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture. (Source: FDA MedWatch)
Source: FDA MedWatch - September 9, 2009 Category: American Health Source Type: organizations

Philips Avalon Fetal MonitorsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress. (Source: FDA MedWatch)
Source: FDA MedWatch - September 5, 2009 Category: American Health Source Type: organizations

Myfortic (mycophenolic acid)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. (Source: FDA MedWatch)
Source: FDA MedWatch - September 3, 2009 Category: American Health Source Type: organizations