PRODUCT SAFETY by FDA

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety alerts, product approvals, announcements, upcoming meetings and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.

PRODUCT SAFETY:

1. Ongoing Safety Review of Stalevo and possible development of Prostate Cancer (Mar. 31)
The FDA is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206363.htm#sa.


2. FDA Requires Device Manufacturers to Include Information on Pediatric Populations (Mar. 31)
The FDA announced that will begin implementing a requirement that device manufacturers provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm206872.htm


3. Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk (Mar. 22)
FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm


4. FDA Warns about Increased Risk of Muscle Injury with Zocor (Mar. 19)
The FDA warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205215.htm


5. The Medicines Company Expands a Nationwide Recall for Certain Lots of Cleviprex® That May Contain Particulate Matter (Mar. 17)
The Medicines Company announced that it is voluntarily expanding the recall of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials. Four (4) additional lots of Cleviprex are being recalled. The four additional Cleviprex lots are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011.
http://www.fda.gov/Safety/Recalls/ucm204997.htm