FDA bans Darvocet: Why so long?

On November 19, 2010, the FDA banned of Darvocet, a widely used pain medication.

Darvocet (and its parent Darvon) is an opiod-based propoxyphene drug prescribed for mild to moderate arthritis pain. The FDA first approved it in 1957 which means it has been on the market for 43 years. Darvon and Darvocet had a bad reputation almost from the beginning. 30 years ago there were clear indications that proproxyphene, besides exhibiting a lack of clear effectiveness, caused the accumulation of heart-toxic metabolites in the body. It was also well-known that the drug was addictive, dangerous for suicidal and depressive patients, and potentially deadly if combined with alcohol.

In 1978, and again in 2006, Public Citizen, a health watchdog group (www.citizen.org), called on the FDA to ban proproxyphene. The UK banned the drugs in 2005 and, according to Public Citizen, approximately 120 million prescriptions for proproxyphene were filled in the U.S. in the five years before the recent FDA ban.

Not until 2009 did the FDA request Xanodyne, the maker of Darvocet, to study the drug for a potential to cause heart rhythm abnormalities.

There are many lessons here. The current practice is for drug companies themselves to do research on the drugs they present for FDA approval. Instead, independent research should be testing the safety and efficacy of drugs. If a drug is approved, there needs to be an intense monitoring of its effects. If a drug is dangerous, the FDA has to have the independence to put the public interest above the interest of the pharmaceutical industry and pull drugs whose secondary bad effects outweigh its good effects…and not wait for millions of people to have used the medication before acting.

(Dr. Arn Strasser is a chiropractor who practices in Portland, Oregon at 2100 NE Broadway, Suite 101. Questions and appointments, please call 503.287.2800).

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