Manufacturer Pulls Darvon, Darvocet; FDA Wants Generic Makers to Do the Same


On Jan. 30, 2009, an FDA advisory committee voted 14-12 against continued marketing of drugs containing propoxyphene. Those who voted to keep it on the market wanted more detailed labeling that warned about use in elderly patients, whose bodies take longer to break down and clear the drug from their systems, and about the risks of taking the drug along with other opioids or alcohol.

In July 2009, the FDA announced it would allow continued marketing of the drug with a new boxed warning that included the risk of fatal overdoses. Acting under new authority, the agency at that time asked Xanodyne to study the effects of the medication on heart rhythms.

The resulting 11-day study on healthy volunteers tested daily doses of 600 mg and 900 mg of the drug. Higher doses never were tested because of cardiac changes seen at the 600 mg and 900 mg levels.

In addition, the agency reviewed other large U.S. databases that collect information on side effects. It found a higher rate of deaths associated with the use of propoxyphene than the narcotic pain relievers tramadol (Ultram) and hydrocodone in five-year reviews of each drug. There were 16 drug-related deaths per 100,000 prescriptions for propoxyphene, compared with 10 per 100,000 prescriptions for tramadol and eight deaths per 100,000 prescriptions for hydrocodone.

As part of Friday's announcement, the FDA recommended that doctors stop prescribing the medication, advise patients using it to stop taking it and discuss other ways to manage pain, and be aware of the potential cardiac effects. Any patient who experiences an abnormal heart rate or heart rhythm, dizziness, lightheadedness, heart palpitations or fainting is advised to contact a doctor immediately.

FDA Lists Alternatives for Pain

Among alternative pain medications are the potentially addictive narcotic drugs oxycodone, hydrocodone and codeine; aspirin; non-aspirin pain relievers such as acetaminophen (Tylenol); and non-steroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin).

However, all have potential side effects. Codeine and other narcotics can cause constipation; aspirin can cause bleeding in the stomach and intestines; acetaminophen can damage the liver; ibuprofen can damage the kidneys; and some of the NSAIDs can cause blood clots dangerous to the heart.

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