Food and Drug Adminstration (FDA): Patient Safety News
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New Medical Products: New Colchicine Product and Dosing Regimen
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FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had n...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Potentially Fatal Errors with Certain Glucose Test StripsEmail this article to a colleague.
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FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Certain Lots of Teva Propofol RecalledEmail this article to a colleague.
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Teva Pharmaceuticals is recalling certain lots of Propofol Injectable Emulsion 10 mg/mL because some of the vials in these lots contain elevated endotoxin levels.
The company says that it has received over 40 reports of patients treated with pro...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Alaris (Medley) Infusion Systems RecalledEmail this article to a colleague.
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CareFusion is alerting healthcare professionals about a number of safety problems with several models of Alaris infusion systems. These problems could cause patients to be over or under-infused, which could lead to serious injury or death.
Certai...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Certain Hospira DevicesEmail this article to a colleague.
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Hospira, Inc. has issued an alert about a number of the company's medical devices that have defective AC power cords. These devices include infusion pumps, compounders, monitoring devices and printers.
This action comes after reports of sparking,...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: ?Nuby? Gel-filled Teethers RecalledEmail this article to a colleague.
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Parents and other caregivers of small children should be aware that the company Luv N' Care Ltd. has recalled almost 20 styles of gel-filled teethers because they might be contaminated with bacteria.
The gel inside these teethers may contain Baci...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Safety Warning on Certain Body-building ProductsEmail this article to a colleague.
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FDA is warning the public not to use body-building products that claim to contain steroids or steroid-like substances, because they can cause serious health problems. These products, which are sold online and in retail stores, are promoted as altern...
Source: Food and Drug Adminstration (FDA): Patient Safety News - October 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: New Warnings on Propoxyphene OverdosesEmail this article to a colleague.
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FDA is taking action to reduce the risk of fatal overdoses in patients taking the pain medication propoxyphene, an ingredient in drugs such as Darvon and Darvocet. Some European studies have indicated that propoxyphene may be more lethal than other ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Fire Hazard with Stabilet Infant WarmersEmail this article to a colleague.
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Hill-Rom Stabilet Infant Warmers were recalled in July because they might pose a fire risk. An infant lying under one of these devices in a hospital nursery suffered second and third degree burns when a fire occurred in the infant's bassinet. The i...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Warning on Neuropsychiatric Effects from Smoking Cessation DrugsEmail this article to a colleague.
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FDA is requiring that two drugs used to help people stop smoking carry new warnings about the risk of serious neuropsychiatric effects. The drugs are Chantix (varenicline) and Zyban (bupropion). The same warnings will be required for other bupropio...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Nephropathy with Certain Organ Transplant DrugsEmail this article to a colleague.
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FDA is requiring that the labeling for several immunosuppressant drugs used to prevent organ rejection after transplants be updated with a warning that these drugs increase the risk of nephropathy associated with the BK virus, which can lead to trans...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Medtronic Mini-Med Paradigm Quick-Set Infusion SetsEmail this article to a colleague.
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In July, Medtronic recalled certain infusion sets which are used with the company's Mini-Med Paradigm insulin pumps to deliver insulin to diabetic patients. Because of a manufacturing error, the vents on these sets may clog and then fail to equalize...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Possible Cancer Risk with LantusEmail this article to a colleague.
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FDA is investigating the possibility that Lantus (insulin glargine) may be associated with an increased risk of cancer. Three of four observational studies published recently in the journal Diabetologia suggested an increased cancer risk associated ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: FDA Studying Cleaning Procedures for Arthroscopic ShaversEmail this article to a colleague.
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FDA is investigating a situation in which pieces of tissue were found within certain arthroscopic shavers even after they were reportedly cleaned according to the manufacturer's instructions. Arthroscopic shavers are devices used in certain orthoped...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Update on Cefepime Safety DataEmail this article to a colleague.
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FDA is updating healthcare professionals about its continuing review of safety data for cefepime, a broad-spectrum cephalosporin antibiotic sold as Maxipime and generics. In 2007, a meta-analysis published in the literature concluded that patients t...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Preventing Medical Errors: Preventing Skin Burns from Surgical MicroscopesEmail this article to a colleague.
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A recent FDA article in the publication "OR Nurse 2009" recommends several ways to prevent skin burns from surgical microscopes, which are used to illuminate and magnify internal structures during surgical procedures. The lights on these devices can...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Preventing Medical Errors: Patient Deaths from Injection of Topical EpinephrineEmail this article to a colleague.
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The Institute for Safe Medication Practices (ISMP) recently cited a report from the ISMP Canada Safety Bulletin about the death of a patient who was accidentally injected with topical epinephrine. The attending surgeon and nurse mistakenly thought t...
Source: Food and Drug Adminstration (FDA): Patient Safety News - September 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Liver Failure with PropylthiouracilEmail this article to a colleague.
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FDA is notifying healthcare professionals about the risk of serious and possibly fatal liver injury associated with propylthiouracil, an anti-thyroid drug used to treat Graves' disease. Propylthiouracil is generally considered second-line therapy in...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Neuropsychiatric Events with Certain Asthma DrugsEmail this article to a colleague.
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FDA has asked the manufacturers of leukotriene-modifying drugs to include a precaution in their labeling about the potential for neuropsychiatric events with these medications. The drugs include Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Certain Infant Apnea MonitorsEmail this article to a colleague.
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Philips/Respironics is recalling some of the company's SmartMonitor 2 Infant Apnea Monitors. These devices are used to monitor infants' heart rate and respiration in the hospital or at home. The monitors are being recalled because they may fail to ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Alert on Stolen Levemir InsulinEmail this article to a colleague.
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FDA is alerting the public that certain vials of the long-acting insulin Levemir were stolen and are being sold in the U.S. market. The stolen vials, which had come from three specific lots, may not have been stored or handled properly. Because of ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Serious Fungal Infections with SimponiEmail this article to a colleague.
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FDA is reminding healthcare professionals about the risk of serious fungal infections with TNF blockers, including Simponi (golimumab), which was recently approved. TNF blockers are immunosuppressants used to treat chronic inflammatory diseases, incl...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Practicing Hospital Bed SafetyEmail this article to a colleague.
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Here's a reminder about the importance of keeping patients safe in hospital beds. These beds are not only found in hospitals, but also in outpatient care centers, long-term care facilities and even at home.
FDA has received hundreds of reports of...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Antiepileptic Drugs and SuicidalityEmail this article to a colleague.
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FDA is alerting healthcare professionals that the labeling for antiepileptic drugs will now warn that patients taking these drugs have an increased risk of suicidal thoughts and actions.
The warnings are based on FDA's analysis of placebo-contro...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Increased Mortality in Liver Transplant Patients Treated with RapamuneEmail this article to a colleague.
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FDA is alerting healthcare professionals that stable liver transplant patients may have an increased risk of death if they are switched from an immunosuppressive regimen based on a calcineurin inhibitor (CNI) to sirolimus. Sirolimus, which is market...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Advice for Patients: Certain Skin Sanitizers/Protectants ContaminatedEmail this article to a colleague.
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FDA is alerting the public that certain skin sanitizers and skin protectants made by Clarcon Biological Chemistry Laboratory are being recalled because they have been found to contain high levels of bacteria. Some of these bacteria could cause infec...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Advice for Patients: Intranasal Zinc May Cause Loss of SmellEmail this article to a colleague.
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FDA has issued a warning that zinc-containing cold remedies administered directly into the nose have been associated with anosmia, which is a loss of the sense of smell. This warning is directed at several over-the-counter products marketed by Matri...
Source: Food and Drug Adminstration (FDA): Patient Safety News - August 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Warning on Testosterone Gel ProductsEmail this article to a colleague.
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FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prev...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Alert on Disetronic ACCU-CHEK Spirit Insulin PumpsEmail this article to a colleague.
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Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps.
The defect can cause the "up" and "down" buttons on these pumps to stop working, ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: New Safety Information on TarcevaEmail this article to a colleague.
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New information has been added to the labeling of the chemotherapy drug Tarceva (erlotinib). The revised labeling now warns about three kinds of serious adverse events:
? Gastrointestinal perforation, which may be fatal. This risk is increased i...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Update on Precipitate Formation with Ceftriaxone and Calcium-containing ProductsEmail this article to a colleague.
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FDA is updating earlier recommendations about the interaction between the antibiotic ceftriaxone and intravenous products that contain calcium. In certain circumstances, this interaction can cause dangerous precipitates to form. Ceftriaxone is sold...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Safety Problems with Denture CleansersEmail this article to a colleague.
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FDA wants healthcare professionals to know about two serious safety problems that have occurred in patients who use denture cleansers. The first is the risk of allergic reactions to these products. These reactions can arise soon after the initial u...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Preventing Medical Errors: Avoiding Infant Burns from Heel WarmersEmail this article to a colleague.
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A recent FDA article in the journal Nursing 2009 warns about the possibility of burns from infant heel warmers. These devices are disposable heat packs used during neonatal care to increase circulation in the infant's heel. Activating the pack prod...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Preventing Medical Errors: Avoiding Errors with Lamictal Starter KitsEmail this article to a colleague.
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A recent FDA article describes medication errors that occurred with patients using Lamictal starter kits. Lamictal (lamotrigine) is used to treat epilepsy and bipolar disorder.
The starter kits give patients the recommended initial dose and dose...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Preventing Medical Errors: Warning on Accidental Ingestion of Benadryl Topical GelEmail this article to a colleague.
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FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring...
Source: Food and Drug Adminstration (FDA): Patient Safety News - July 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Raptiva Withdrawn from the MarketEmail this article to a colleague.
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Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Zoll AED Plus Defibrillator RecalledEmail this article to a colleague.
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The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recalls of Digoxin and Propafenone TabletsEmail this article to a colleague.
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FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets:
? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt CathetersEmail this article to a colleague.
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Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Preventing Misconnection Errors ? Medical Device Safety CalendarEmail this article to a colleague.
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FDA has received many reports of patient injuries and deaths when different device delivery systems are mistakenly connected to each other. These errors are often facilitated by fittings called Luer Connectors, which allow different systems to be ea...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Zencore PlusEmail this article to a colleague.
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Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
New from FDA: Campaign on Using Methadone SafelyEmail this article to a colleague.
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FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
Advice for Patients: Help Patients Use Acetaminophen SafelyEmail this article to a colleague.
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Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in this country each year. Many of these events are happening because patients are unknowingly taking too much of the drug.
Several factors co...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
FDA Consumer Corner: Don?t Overdo It with AcetaminophenEmail this article to a colleague.
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If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and...
Source: Food and Drug Adminstration (FDA): Patient Safety News - June 1, 2009 Category: American Health Source Type: news
New Medical Products: FDA Approves First Human Drug from Genetically Engineered AnimalsEmail this article to a colleague.
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FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. The...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Safety Problems with Baxter Colleague Volumetric Infusion PumpsEmail this article to a colleague.
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Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's le...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Warning on MetoclopramideEmail this article to a colleague.
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FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and i...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Burns from Medicated Patches during MRI ExamsEmail this article to a colleague.
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FDA is warning healthcare professionals and patients that medicated patches with metallic backings can cause skin burns during MRI exams. These patches include both prescription and OTC products, including nicotine patches. The metallic backings ar...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Recall of Pediatric Tracheostomy TubesEmail this article to a colleague.
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Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as probl...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
Recalls and Safety Alerts: Alert on Metabolic Acidosis from ZonisamideEmail this article to a colleague.
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FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with ...
Source: Food and Drug Adminstration (FDA): Patient Safety News - May 1, 2009 Category: American Health Source Type: news
