The U.S. Food and Drug Administration is taking several actions
to reduce the risk of overdose in patients using pain
medications such as Darvon and Darvocet that contain
propoxyphene. The actions were taken because of data linking
propoxyphene and fatal overdoses. The agency is requiring
manufacturers of propoxyphene-containing products to strengthen
the label, including the boxed warning, emphasizing the
potential for overdose when using these products. These
manufacturers will also be required to provide a medication
guide to patients stressing the importance of using the drugs as
directed. In addition, the FDA is requiring a new safety study
assessing unanswered questions about the effects of propoxyphene
on the heart at higher than recommended doses. Findings from
this study, as well as other data, could lead to additional
regulatory action. “Physicians need to be aware of the risk of
overdose when prescribing these drugs. They should carefully
review patient histories and make appropriate treatment deci