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FDA Cracks Down on Unapproved Narcotic Painkillers

By David Goguen on April 01, 2009 | Last updated on March 21, 2019

The FDA is cracking down on the marketing of unapproved drugs that may be unsafe or ineffective for patients. On Tuesday, the agency ordered nine drug companies to stop selling 14 potent narcotic painkillers that have not received a green light from the FDA.

Even narcotic painkillers that have been appproved by the FDA have known and potentially dangerous side effects and addiction risks. But when unapproved medications containing potent drugs like morphine and oxycodone hit the marketplace, questions about their safety, purity, and effectiveness remain up in the air.

The nine drug companies that received notice from the FDA must stop the manufacture of unapproved narcotic painkillers within 60 days, and all shipments must end within 90 days. 

Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said on Monday: "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

An FDA News Release announcing Tuesday's action seeks to assure patients and caregivers that there is no shortage of approved, safe and effective versions of narcotic painkillers. The agency is advising patients who may be taking affected medications to visit the FDA's Unapproved Drugs web page, which lists all manufacturers of unapproved products. If there is any doubt over whether a painkiller has been approved, patients are urged to talk with their health care professionals as soon as possible.

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