FDA Takes Action on Darvon, Darvocet

The U.S. Food and Drug Administration has taken action to reduce the risk of overdose for people who take pain medications containing propoxyphene, which is sold under the brand names Darvocet, Darvon, Darvon-N and Dolene. Propoxyphene has been linked to recent deaths from overdose.

Propoxyphene is a widely prescribed medication used to treat mild to moderate pain. It is in a group of drugs known as opioids, and has been on the market since 1957.

The FDA found that propoxyphene is an effective treatment for pain when taken at recommended doses, but because of the potential risk of the drug, the agency is requiring manufacturers to provide more warnings and additional information to physicians and patients.

FDA Actions

Last week, the FDA took the following actions regarding propoxyphene:

• Required manufacturers to strengthen the label's boxed warning to emphasize the risk for overdose when using these products.

• Required manufacturers to provide a medication guide given to patients with each prescription to stress the importance of using the pain drugs only as directed.

• Required a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.

• Planned to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.

• Denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.

• Planned to further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.

If you are someone you know is taking a pain medication containing propoxyphene, be sure it is used only at the recommended dosage. Overdose occurs when someone takes too much of this medicine.

News Source: FDA Takes Action on Darvon and Other Pain Medications

Related Information:

• Propoxyphene Overdose
  
• The Danger of Sedative Overdose
  
• Drug Overdose Deaths Double in Five Years

^{Photo: DEA}