Nationsl Intitutes of Health
Makers of drug products containing the opioid proxyphene have one month to comply with a U.S. Food and Drug Administration request to strengthen warnings about the possibility of taking a fatal overdose of the medication.
FDA officials announced on July 7 that numerous reports of individuals suffering heart atacks after taking high doses of propoxyphene prompted the call for black box warnings on product labeling and packaging. Bolded statements that patient should take only the prescribed amounts of propoxyphene.would be reiterated in Medication Guides distributed along with filled propoxyphene prescriptions at the pharmacy counter .
The agency also comitted to joining with Medicare and the Veterans Health Administration to study whether the benefits of propoxyphene use outweighed the risks and whether propoxyphene worked better than other opioids for some patients.
Available since 1957, propoxyphene is already classified as a Schedule II controlled substance by the Drug Enforcement Administration and subject to strong prescribing restrictions. People taking propoxyphene to control pain most often experience dizziness, drowsiness and nausea as side effects.
While calling for new warnings and data on proxyphene safety, the FDA also rejected a petition from the consumer-advocacy group Public Citizen that requested a phased withdrawal of propoxyphene.
The two best-known prodcuts containing propoxyphene are Darvon and Darvocet, both of which are marketed by Xanodyne Pharmaceuticals. Many generic proxyphene products are available, and Darvocet formulations that also contain acetaminophen may soon be subject to other regulatory actions.
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