The U.S. Food and Drug Administration has notified some pharmaceutical companies to stop manufacturing and distributing unapproved drugs that contain oxycodone, a widely prescribed and potentially addictive opioid painkiller.
The FDA action involves single-ingredient, immediate-release oxycodone drugs in tablet, capsule and liquid form. The medications have not been evaluated by the FDA for safety, effectiveness, manufacturing quality or appropriate labeling, and cannot be legally marketed in the U.S. The companies were given 45 days to stop manufacturing the drugs and 90 days to stop distributing them.
An FDA spokesperson told American News Report the order involves only a “small number” of oxycodone medications. The agency has not publicly disclosed what drugs or pharmaceutical companies are involved.
“We’re trying our best not to point fingers,” she said.
Oxycodone is a potent painkiller and, like other opioids, is classified as a Schedule II narcotic medication. In 2009, there were over 15,500 fatal overdoses involving opioid painkillers such as oxycodone.
“It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”
The FDA is seeking removal of the drugs from the market under the Unapproved Drugs Initiative, which began in 2006.
In 2009, the FDA sent warning letters to nine companies making 14 unapproved narcotic drugs, including oxycodone. Some current oxycodone manufacturers were included in that warning, but how many are involved in the new FDA order is unclear.
The agency did not say why it is taking so long to remove the unapproved drugs from the market.