FDA Takes Action on Darvon and Other Pain Medications
On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.
FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.
- FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
- FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.
- FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
- FDA is planning 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.
- FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
- FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.
- Propoxyphene has been on the market since 1957.
- It is a widely prescribed medication in a group of drugs known as opioids, and is used to treat mild to moderate pain.
- The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.
Advice for Consumers
- Be aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.
- Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: July 14, 2009