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Painkillers Darvon, Darvocet withdrawn amid serious health concerns

The U.S. regulators were considering acting against propoxyphene after an advisory panel voted 14-12 to recommend its withdrawal in July 2009.

In compliance with the request of the U.S. Food and Drug Administration (FDA), Xanodyne Pharmaceuticals Inc. has agreed to withdraw the narcotic painkillers Darvon and Darvocet from the U.S. market because of serious health concerns.

Darvon and Darvocet are the brand version of the prescription pain medication propoxyphene.

According ton the FDA, clinical trials have proved that propoxyphene increases the risk of "serious or even fatal heart rhythm abnormalities."

John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER) stated, "FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market.

"These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

Risks outweigh the benefits
The regulatory action against the widely prescribed pain relievers came after the FDA weighed the pros and cons and discussed safety and effectiveness data for Darvon and its generic copies.

Analysis of the new clinical and epidemiological data revealed the drug even at recommended doses can affect the electrical activity of the heart, causing potentially serious or even fatal heart rhythm abnormalities in healthy patients and not just those weakened by illness.

Gerald Del Pan, the FDA's director of the office of surveillance and epidemiology, stated, "With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.

"However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away."

A little about the drugs
Darvon and Darvocet, known generically as propoxyphene, are opioid narcotic commonly prescribed to treat mild to moderate arthritis pain.

Darvon has been in the market since 1957 when there were few alternatives for treating pain except aspirin and powerful narcotics.

Products containing propoxyphene have been on the market for approximately 50 years, and they have been used by millions of patients.

Though propoxyphene is associated with more than 2,000 accidental deaths in America since 1981, Darvon remains in the top 25 prescribed medications.

The regulatory action against the widely prescribed pain relievers came after the FDA weighed the pros and cons and discussed safety and effectiveness data for Darvon and its generic copies.

The United Kingdom announced in 2005 that it will ban propoxyphene- containing drugs. The Europe Medicines Agency proposed a ban in 2009.

FDA urges patients to switch to alternative medicines
The U.S. regulators were considering acting against propoxyphene after an advisory panel voted 14-12 to recommend its withdrawal in July 2009.

However, the agency approved its marketing with strong new warnings about the risks.

The health regulators are urging doctors to stop prescribing such pain killers and are advising patients under the medication to consult their physicians for an alternative treatment.

Diana Zuckerman of the National Research Center for Women and Families stated, “It is a perfect example of how the FDA is now saving lives by reversing past approval decisions.

"Patients and consumers will be healthier and live longer when the FDA is willing to put the public's health first, as it did today."