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Propoxyphene Banned from US after 53 years

Kathleen Blanchard's picture

Propoxyphene was first approved by the FDA in 1957, as an uncontrolled analgesic. After 53 years, the FDA is recommending the drugs, marketed as Darvon and Darvon Compound (contains acetaminophen) be pulled from the US market.

Propoxyphene Disturbs Electrical Activity of Heart

Throughout the years the drug has undergone several recommendations from the FDA due its safety/risk profile. In 1976, propoxyphene became a schedue IV controlled drug. It does not cause drowsiness and treats mild to moderate pain, but some potential for abuse was noted.

For a few, the drug is addictive, but the profile for abuse has never been high. In 1978, the FDA decided to ignore citizen petitions asking for a boost to a Schedule II controlled drug, based on evidence that abuse was not high and the drug could control pain as designed.

Other names for the drug include Dolene, Propacet 100, Wygesic, SK-65, SK-65 APAP, Trycet, Genagesic, E-Lor, and Balacet. It is also sold generically as propoxy/APAP or just plain propoxyphene.

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If you are taking the drug, the FDA says, "Take the propoxyphene out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. Put the medication in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag." Speak with your doctor about other pain control options that include narcotics or NSAIDS that also carry risks.

A comparison of deaths associated with medications for pain control are as follows - 16 per 100,000 prescriptions for propoxyphene, 10 deaths per 100,000 prescriptions for tramadol and 8 deaths per 100,000 prescriptions for hydrocodone. The higher number of deaths was included in the decision to stop marketing the medication in the US.

In 2009, the FDA panel again reviewed propoxyphene, voting 14 to12 against continued marketing, but there wasn't enough information about the effects of the drug on the heart. In July 2009, the FDA included a black box warning about the dangers of overdose.

Now the FDA is withdrawing propoxyphene because, even at the recommended dose, it can disturb the electrical activity of the heart. Specifically, the drug causes prolonged PR interval, widened QRS complex and prolonged QT interval. The consequences of each are 1st degree heart block, what is known as a bundle branch block that could lead to unncessary testing for another underlying cause, and the chance of life-threatening heart rhythm disturbances respectively. Based on the final piece of evidence, that the drug can cause arrhythmia, the FDA made the decision to take the drug off the market, after 53 years.




OMG! I just heard on the news that Darvocet was banned today--risks have been known for a while and was already banned in Europe. The dentist just prescribed Darvocet for a family member who has afib--the dr. was informed of his heart condition!!! What the ???? is going on with drs these days? Don't they read warnings!