The agency will require manufacturers to provide a medication guide with all prescriptions and refills stressing the importance of taking the drugs as directed to reduce overdose risk.
In addition, Woodcock said there are plans underway with the Medicare and Veterans Administration systems to conduct additional studies, including one that involves the safety and prescribing patterns of propoxyphene among the elderly, specifically with regard to the rates of fatalities and hip fractures.
The FDA will also analyze a review of medical examiners' data in the Substance Abuse and Mental Health Administration's Drug Abuse Warning Network (DAWN).
So far, there's been little data available on overdoses, since intentional overdoses are typically not reported to the FDA, said Dr. Gerald Dal Pan of the agency's Center for Drug Evaluation and Research.
Over a 35-year period, 91 deaths related to propoxyphene have been reported to the FDA. But most were suicide attempts with multiple drugs, so it's hard to establish a direct causal role for propoxyphene, Dal Pan said.
This article was developed in collaboration with ABC News.