Healthcare

Propoxyphene is pain reliever medication that categorized as analgesic under trade-name Darvocet and Darvon by Eli Lilly and later sold to Xanodyne Pharmaceuticals, which were approved by the U.S. Food and drug Administration (FDA) in 1957.

Before the FDA removed propoxhphene on the market in November 2010, several cases reported regarding to side effects from propoxyphene use.

Since approved in 1957 by the FDA, at least 2 reports received by the FDA since 1978 to request removing of the products from the market.

However, in January 2009, the FDA still decided continued marketing the product, but with a new boxed warning added to the drug label alerting of the risk for fatal overdose.

Finally, in November 2010, the FDA decided to removed propoxyphene from the market based on epidemiologic data and medical examination, including a new potential risk of serious or even fatal heart rhythm abnormalities or arryhtmias, along with its suicide risk.

Many experts asked why the FDA take so long to remove the products after 53 years on the market and had received some fatal adverse reports.

According to the director of the Office of Surveillance and Epidemiology, Gerald Dal Pan, MD,
the regulators did not feel there was sufficient evidence earlier until it founds the effects of the electrical activity on the heart.

A researchers from Sweden who involved in removing propoxyphene in the UK (5 years ago), Sweden, and later all Europe Union, said that propoxyphene is the drug caused so many deaths and the worst drug ever made in medical history.

He said that he never seen a single drug contributed so many death risk than propoxyphene.