NEWS - FDA orders new warnings for propoxyphene - Darvon, Darvocet

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Overdose Warning for Pain Drug Propoxyphene

FDA Strengthens 'Black Box' Warning and Orders More Studies for

Painkiller Propoxyphene, Sold Generically and as Darvon and Darvocet

By Miranda Hitti

WebMD Health News

Reviewed by Louise Chang, MD

July 7, 2009 -- The FDA today ordered new warnings about overdose risk

for the pain medication propoxyphene, which is sold generically and

under the brand names Darvon and Darvocet.

The FDA is requiring the " black box " warning -- the FDA's sternest

warning -- on drugs containing propoxyphene to emphasize the potential

for overdose. The FDA also ordered more studies of propoxyphene's

safety.

But the FDA didn't ban propoxyphene, although an advisory committee

narrowly voted in January to recommend such a ban.

The FDA often follows the advice of its advisory committees, but it's

not required to do so.

In this case, the FDA decided that drugs containing propoxyphene are

an " acceptable option for mild to moderate pain when taken as

directed, " Janet Woodcock, MD, director of the FDA's Center for Drug

Evaluation and Research, said today in a news conference.

Propoxyphene has been on the market since 1957. From 1969 to 2005, the

FDA got 91 reports of deaths in people taking propoxyphene. Most of

those deaths were drug overdoses and suicide attempts, often involving

multiple drugs, Gerald Dal Pan, MD, MPH, director of the FDA's Office

of Surveillance and Epidemiology, said during today's news conference.

Woodcock said the FDA took another look at propoxyphene after the

nonprofit group Public Citizen filed a petition in 2006 calling for

the drug's ban. Woodcock also noted that the FDA has been reviewing

other types of pain relievers, including last week's meeting on

acetaminophen safety.

http://www.webmd.com/pain-management/news/20090707/overdose-warning-for-pain-dru\

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