Here is the article on darvon/darvocet being pulled off the market by FDA

[Guest guest]

WASHINGTON — The maker of Darvon and Darvocet announced Friday that it will

stop marketing the widely used painkillers in the U.S. because of a new

study linking the active ingredient in the drugs to serious and sometimes

fatal heart rhythm abnormalities.

Xanodyne Pharmaceuticals Inc., of Newport, Ky., agreed to the ban at the

request of the Food and Drug Administration, which also asked makers of

generic versions of the drugs' core compound, known as propoxyphene, to stop

selling it in the U.S.

The decision to yank propoxyphene brings the U.S. in line with regulatory

agencies in Britain and the _European Union_

(http://www.latimes.com/topic/economy-business-finance/economy/european-union-OR\

GOV000067.topic) , which

pulled the drug from the market more than a year ago.

Propoxyphene was first approved by the FDA in 1957, but has been shadowed

for years by safety concerns.

In January 2009, an FDA advisory committee voted 14-12 against continued

marketing of the drug.

The FDA rejected that recommendation, but required a study of the drug's

cardiac effects.

The study showed that the drug increases risks for heart _arrhythmias_

(http://www.latimes.com/topic/health/physical-conditions/cardiac-arrhythmia-HEPH\

C

0000011.topic) even in healthy patients, not just those weakened by

illness.

In announcing the withdrawal of the drug, the FDA urged doctors to stop

prescribing it immediately. But it advised patients to continue taking propoxy

phene, while consulting quickly with doctors to arrange for alternative

medication.

The FDA estimated that 10 million patients received propoxyphene in the

U.S. in 2009, most of them in combination with acetaminophen, a compound

known by the Darvocet trade name.