WASHINGTON (CNN) -- The Food and Drug Administration is requiring makers of painkillers containing propoxyphene, the ingredient in widely used Darvon and Darvocet, to add a warning box to the label highlighting the potential for overdose.
Manufacturers must also develop a medication guide for consumers emphasizing the importance of using the drug as directed and conduct a new safety study to assess what the drug does to patients when taken in higher-than-recommended doses.
The opioid, used to treat mild to moderate pain, has been on the market since 1957.
"Physicians need to be aware of the risk of overdose when prescribing these drugs," said Dr. Janet Woodcock, director of the food and drug agency's Center for Drug Evaluation and Research. "They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label.
"Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy."
The agency says that from 1969 to 2005, 91 deaths were related to drug overdoses and suicide attempts involving medications containing propoxyphene. Darvon and Darvocet are made by Xanodyne Pharmaceuticals Inc. of Newport, Kentucky.
In 2006, the consumer advocacy group Public Citizen petitioned the Food and Drug Administration to ban all propoxyphene products. But the agency announced Tuesday that it had denied that petition, saying the benefits of the pain medication at the proper dosage outweigh the risks.
The agency noted that all pain medicines have side effects. The most common ones of propoxyphene use are lightheadedness, nausea, dizziness and vomiting.
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