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Why Is Darvocet Being Recalled?

Why Is Darvocet Being Recalled? - The popular painkillers Darvocet and Darvon have been recalled by the FDA after it was determined that all medications containing the painkiller propxyphene pose an unreasonable risk of heart problems.

The Darvocet and Darvon recall was announced Friday afternoon by the FDA and Xanodyne Pharmaceuticals, Inc., which manufactures the popular pain medications. All generic Darvocet and generic Darvon versions of the medication have also been recalled.

Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Today it is most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol.

Darvocet has become one of the 25 most commonly prescribed medications, which has been prescribed to more than 22 million people.

An FDA advisory panel first recommended that the agency recall Darvocet and Darvon in February 2009, after determining that the minimal pain relief benefits provided by the drugs do not outweigh the substantial risk of overdose and suicide. However, the FDA decided in July 2009 to allow the medications to remain on the market with a new “black box” warning about Darvon and Darvocet side effects, which is the most stringent warning label possible under federal regulations.

Why Is Darvocet Being Recalled?

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