FWD:FDA Advisory Panel Votes to Ban Painkillers Darvon, Darvocet
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FWD:FDA Advisory Panel Votes to Ban Painkillers Darvon, Darvocet
FDA Advisory Panel Votes to Ban Painkillers Darvon, Darvocet
FDA advisors voted Friday to recommend banning the painkiller propoxyphene — marketed alone as Darvon, and combined with acetaminophen as Darvocet — the Associated Press reports.
The 14-12 vote followed a meeting prompted by the consumer group Public Citizen, which contends that the drug offers little pain relief, with a high potential for abuse.
The FDA has received over 3000 reports of serious propoxyphene-related problems, including suicide, drug dependence, and overdose, according to the AP. (The labels of both Darvon and Darvocet currently warn against prescribing the drugs for patients who are suicidal or prone to addiction.)
It is not yet known how the FDA will act on the advisory panel's recommendations.
LINK(S):
Associated Press coverage of vote (Free)
AP preview of advisory panel meeting (Free)
Manufacturer briefing materials for advisory panel meeting (Free PDF)
Darvon label (Free PDF)
Darvocet label (Free PDF)
Published in Physician's First Watch February 2, 2009
FDA advisors voted Friday to recommend banning the painkiller propoxyphene — marketed alone as Darvon, and combined with acetaminophen as Darvocet — the Associated Press reports.
The 14-12 vote followed a meeting prompted by the consumer group Public Citizen, which contends that the drug offers little pain relief, with a high potential for abuse.
The FDA has received over 3000 reports of serious propoxyphene-related problems, including suicide, drug dependence, and overdose, according to the AP. (The labels of both Darvon and Darvocet currently warn against prescribing the drugs for patients who are suicidal or prone to addiction.)
It is not yet known how the FDA will act on the advisory panel's recommendations.
LINK(S):
Associated Press coverage of vote (Free)
AP preview of advisory panel meeting (Free)
Manufacturer briefing materials for advisory panel meeting (Free PDF)
Darvon label (Free PDF)
Darvocet label (Free PDF)
Published in Physician's First Watch February 2, 2009
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