FDA Takes Action on Darvon, Other Pain Medications Containing Propoxyphene

FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses.

The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

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. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Related posts:

1. Propoxyphene-containing Products
2. Prescription pain medications becoming a plague on society
3. BioSante Pharmaceuticals’ ongoing LibiGel Phase III clinical development program: Additional positive data

Buy the Painkiller drugs from Canadian Pharmacy free prescription online. Hydrocodone is a semi-synthetic opioid similar in effects to morphine. Vicodin is hydrocodone mixed with acetaminophen. Oxycodone is used as an analgesic and is formulated into numerous pharmaceuticals including OxyContin (a controlled-release product) and with aspirin (Percodan) or with acetaminophen (Percoset).