October 2009, Volume 39 Number 10 , p 16 - 17
As a result of data linking opioid pain medications and fatal overdoses, the FDA is taking action to reduce the risk. The agency is requiring manufacturers of products containing propoxyphene, such as Darvon and Darvocet, to emphasize the potential for overdose in a black box warning on the product's packaging. Manufacturers will also be required to provide a Medication Guide for patients that stresses the importance of following directions carefully when taking the drug.
In addition, the FDA is requiring a new safety study to assess unanswered questions about the effects of higher doses of propoxyphene on the heart. They're also working with the Centers for Medicare and Medicaid Services and the Veterans Health Administration to study how often older patients are prescribed drugs containing propoxyphene instead of other pain medications, and the ...