FDA Recalls and Safety Alerts

FDA Recalls and Safety Alerts

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Warning on Proton Pump Inhibitors and Fracture Risk
FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist and spine. August 2010
Lifeline and ReviveR AED Battery Packs Recalled
Defibtech is recalling certain battery packs used in Lifeline and ReviveR automatic external defibrillators (AED). These battery packs may cause the AED to inappropriately cancel the charge and be unable to deliver therapy. August 2010
Thrombosis with Off-Label Promacta Use
GlaxoSmithKline is warning healthcare professionals about the risk of thrombosis if patients with chronic liver disease are treated with Promacta (eltrombopag). Promacta is approved to treat thrombocytopenia in certain adult patients with chronic idiopathic thrombocytopenic purpura (ITP). August 2010
Severe Liver Injury with Orlistat (Xenical, Alli)
The labeling for the weight loss drug orlistat will include new safety information about rare cases of severe liver injury in patients taking this drug. Orlistat is sold by prescription as Xenical in 120 mg strength and over the counter as Alli in 60 mg strength. August 2010
Dosing Errors with Certain Oral Syringes
The Institute for Safe Medication Practices (ISMP) recently pointed out that measuring doses with certain oral syringes can be confusing for healthcare practitioners and patients, and that this can lead to overdoses. August 2010
Help FDA Stop “Bad Ads”
FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. August 2010
New Cellular Immunotherapy for Advanced Prostate Cancer
The FDA has approved a new therapy for certain men with advanced prostate cancer called Provenge (sipuleucel-T). July 2010
Warning on Liver Injury with Propylthiouracil
In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil. July 2010
Medication Guide Required for Vivitrol
The pharmaceutical company Alkermes has developed a Medication Guide for patients being treated with Vivitrol. July 2010
Certain AQUA+FLEX Humidifiers Recalled
Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers. These devices are passive humidifiers used during mechanical ventilation to warm and humidify inspired gas. July 2010
Using External Infusion Pumps Safely
External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. July 2010
New Formulation for OxyContin
FDA has approved a new formulation of the controlled-release drug OxyContin that is designed to be more difficult to manipulate by someone trying to misuse or abuse the medication. June 2010
First Absorbable Sealant Patch for Cardiovascular Surgery
FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. June 2010
Reduced Effect from Plavix in Some Patients
Through a new boxed warning, the FDA is alerting healthcare professionals about a subgroup of patients who cannot effectively metabolize the anti-platelet drug Plavix (clopidogrel). June 2010
Muscle Injury from High Doses of Zocor
FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. June 2010
Companies to Stop Marketing Unapproved Nitroglycerin Tablets
FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. June 2010
SureStep Test Strips Recalled
LifeScan is recalling certain lots of SureStep glucose test strips because they may provide falsely low results when glucose levels are above 400 mg/dL. If these results are used to adjust insulin doses, too little insulin could be administered. This could result in severe hyperglycemia, coma and death. May 2010
Recall of UniCel DxC Clinical Analyzers
Beckman Coulter is alerting clinical laboratories about the importance of following twice-a-week maintenance procedures for the company's UniCel DxC clinical chemistry analyzers. May 2010
Risk Management Program for Procrit, Epogen and Aranesp
FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. May 2010
Avoiding Maalox Mix-ups
All liquid Maalox products are not the same. Maalox Total Relief, Maalox Advanced Regular Strength, and Maalox Advanced Maximum Strength may look similar but they are not interchangeable. In fact, using the wrong one could be harmful. May 2010
Certain Powerheart/CardioVive/CardioLife AED Recalled
In February, Cardiac Science Corporation initiated a recall of several models of automated external defibrillators because manufacturing problems may make them susceptible to failure. April 2010
Recall of Q-Syte Luer Access Devices
Here's an alert about certain lots of Q-Syte Luer access devices. April 2010
Cardiovascular Risk with Meridia
FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity. April 2010
SafeSheath CSG Hemostatic Introducer Recalled
Thomas Medical Products Inc. has recalled the SafeSheath Coronary Sinus Guide Introducer. April 2010
Measuring Rapamune Blood Concentrations
Wyeth is cautioning healthcare professionals about therapeutic drug monitoring for Rapamune (sirolimus). Rapamune is used to prevent organ rejection in certain renal transplant patients.  April 2010
GlucoPro Insulin Syringes Recalled
Nipro Medical Corporation has recalled the company's GlucoPro insulin syringes because the needle may detach from the syringe.  April 2010
Safety Precautions for Huber Needles
FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products.  March 2010
Kidney Impairment with Byetta
To help clinicians weigh the benefits and risks of the diabetes drug Byetta (exenatide), FDA is requiring that information about the risk of renal impairment be added to the drug's labeling.  March 2010
Warning on Counterfeit Alli
FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat).  March 2010
Chondrolysis with Continuously Infused Local Anesthetics
FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain.  February 2010
Synex II Spinal Implant Recalled
In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine. February 2010
New Warnings on Norpramin
Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). February 2010
Serious Complications with Negative Pressure Wound Therapy
FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT).  January 2010
Warning Against Nebulizing Relenza Inhalation Powder
GlaxoSmithKline is alerting healthcare professionals about the dangers of reconstituting Relenza (zanamivir) Inhalation Powder into a liquid and using it in a nebulizer or mechanical ventilator.  January 2010
Nationwide Recall of AccuSure Insulin Syringes
Qualitest Pharmaceuticals is recalling all lots of AccuSure insulin syringes because the syringe needle may detach from the syringe.  January 2010
Preventing Anaphylactic-type Reactions with Dexferrum
American Regent has issued new precautionary measures for preventing anaphylactic-type reactions when administering Dexferrum (iron dextran injection).  January 2010
Energy Levels in External Biphasic Defibrillators
FDA is looking into the safety and effectiveness of biphasic defibrillators used for cardioversion and defibrillation in order to understand the conditions that affect their performance.  January 2010
2009 Archives (Click Here)
FDA Patient Safety and Advice
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