Food and Drug Adminstration (FDA): Patient Safety News

Recalls and Safety Alerts: Warning on Proton Pump Inhibitors and Fracture Risk

07/31/2010 11:00 PM
FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist and spine. The drugs' labeling will be revised to reflect these concerns. PPIs are used to reduce gastric...

Recalls and Safety Alerts: Lifeline and ReviveR AED Battery Packs Recalled

07/31/2010 11:00 PM
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. The company has received...

Recalls and Safety Alerts: Update on Counterfeit Polypropylene Mesh

07/31/2010 11:00 PM
FDA now has more information on the counterfeiting of Bard flat polypropylene surgical mesh, commonly known as Marlex mesh. This was first reported earlier this year. The counterfeit products, which were distributed between October 21, 2008 and Octo...

Recalls and Safety Alerts: Thrombosis with Off-Label Promacta Use

07/31/2010 11:00 PM
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 id...

Recalls and Safety Alerts: Severe Liver Injury with Orlistat (Xenical, Alli)

07/31/2010 11:00 PM
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 6...

Preventing Medical Errors: Dosing Errors with Certain Oral Syringes

07/31/2010 11:00 PM
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. This type of syringe is pack...

Preventing Medical Errors: Reporting Adverse Events to MedWatch

07/31/2010 11:00 PM
An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up i...

New from FDA: Help FDA Stop ?Bad Ads?

07/31/2010 11:00 PM
FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. But it is difficult for the agency to check on these activities when they take place in doctors' offices, or i...

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