ROCKVILLE, Md. Manufacturers of painkillers containing an opioid must strengthen labels for the drugs due to the risk of overdose, the Food and Drug Administration has ordered.
The FDA announced Tuesday that it would require the strengthened warnings in light of data linking propoxyphene and fatal overdoses. The drug has been on the market since 1957.
“Physicians need to be aware of the risk of overdose when prescribing these drugs,” FDA Center for Drug Evaluation and Research director Janet Woodcock stated. “They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label.”
The agency rejected a petition from the group Public Citizen calling for a phased withdrawal of the drug, saying that the benefits of the drug outweighed the risks.