FDA Withdrawal of Darvon and Darvocet

Darvon, which gained FDA approval in 1957 and Darvocet, FDA approved in 1972, have been in the news recently because the maker of both products, Xanodyne Pharmaceuticals, Inc., withdrew them from the U.S. market. While this move may generally be referred to as a “recall” it actually is not. But before stating why that is the case, it is necessary to understand what powers the Food and Drug Administration (FDA) does, and does not, possess.

The FDA does not have the authority to issue a recall. It may request that a company recall a product, and companies typically do comply. But a request is just that. A company could deny the request, at which point the FDA’s only recourse, aside from applying pressure through the media, would be to seek a court order authorizing the federal government to seize the product in question. Generally, though, recalls are voluntary, and often, a company will recall a dangerous or defective product itself without government prompting.

It is also necessary to distinguish between a recall and a withdrawal. A recall is often associated with a manufacturing error or a deviation from an accepted manufacturing standard, and so only applies to a specific quantity of a product and is temporary.  Assuming that a company fixes the problem that caused the product to become dangerous or defective, it will be allowed to return to market. A withdrawal is a type of recall (Category 1), but applies permanently to the entire stock of a product.  When the FDA requests a withdrawal, it is usually because the nature of the product (for example, the chemical it contains) has serious side effects, including death, and is unsafe under all circumstances.

What the FDA actually requested in November 2010 was a withdrawal of all products containing propoxyphene, a narcotic painkiller used for the treatment of mild to moderate pain. This request applies to Xanodyne in addition to all generic manufacturers of products containing propoxyphene.  Xanodyne complied with the request on November 19 and issued the following statement: “Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon®, Darvon-N®, and Darvocet-N® products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).”

There had been controversy surrounding the safety of propoxyphene for more than three decades due to data that supports the drug’s link to potentially fatal heart problems and accidental overdoses. In January 2009, an advisory committee to the FDA voted to discontinue marketing of propoxyphene products, but the FDA overruled, choosing to instead use power given to it by recent legislation to require postapproval studies. It ordered Xanodyne to conduct studies on the effects of propoxyphene on the heart’s electrical activity. The results of these tests showed clear evidence that even at recommended doses, the drug can cause heart rhythm abnormalities.

In requesting the withdrawal of all propoxyphene products, the FDA additionally recommended the following actions be taken by patients taking a product containing the drug:

  • Speak with your healthcare provider about discontinuing propoxyphene and taking a different pain medication. You should also express any concerns or ask any questions you have about taking the drug.
  • If you experience any symptoms of heart rhythm abnormalities, including dizziness or lightheadedness, contact your doctor immediately. In addition, report the side effects to the FDA.
  • Dispose of remaining doses of propoxyphene according to the Federal Drug Disposal Guidelines

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