Information for Healthcare Professionals: Exenatide (marketed as Byetta)

Update 8/8/2008:  The FDA is notifying the public of the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. A revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily. However, the FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin, particularly with simvastatin doses greater than 20 mg daily. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

FDA: Injectable Heparin Products And Heparin Flush Solutions May Be Contaminated With Oversulfated Chondroitin Sulfate

The FDA  recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS).   Affected heparin products have been found in medical care facilities in one state since the recall announcement.  Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.  There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration.  Please see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm. 

The FDA asks that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.   

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