FDA strengthens Darvon, Davvocet warnings

WASHINGTON, July 7 (UPI) -- The U.S. Food and Drug Administration says it has ordered strengthened warnings for drugs, such as Darvon and Darvocet, that contain propoxyphene.

The federal agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose. The 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 ordered a new safety study assessing the effects of propoxyphene on the heart at higher than recommended doses.

Officials said propoxyphene has been on the market since 1957 as a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain.

FDA officials said they plan to work with several groups, including the Centers for Medicare & Medicaid Services, to determine how often elderly people are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared with other drugs.

The agency Tuesday denied a petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The FDA said the benefits of using the medication for pain relief at recommended doses outweigh the safety risks at this time.

An overview of the decision is available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm.