FDA Warns Against Unapproved Drugs
By Meghan O’Dell
In late March, nine drug companies were ordered by the FDA to stop manufacturing pain relief narcotics that have not been approved. The drugs include high-concentrated morphine solutions in oral form and immediate-release tablets containing morphine sulfate, hydromorphone, or oxycodone, all of which are forms of previously approved medications.
The drugs aren’t known to be unsafe, but because they are being sold without FDA approval, there is no way for the FDA to know if they were made safely, contain labeled ingredients, or carry correct dosages. “Companies owe it to patients to ensure their drugs are legally marketed,” said Deborah Autor, J.D., director of the office of compliance at the FDA’s Center for Drug Evaluation and research. She continued, “Today’s action is about ensuring Americans have safe and effective drugs and getting the message to companies that they have a responsibility to patients.”
The companies were given 60 days to pull the drugs from shelves, and distributors were given 90 days to stop shipping them. If the deadlines are not met, the companies could face legal action, and the drugs could be seized. “We estimate there are several hundred unapproved drugs out there,” Autor said. “We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs.” Autor also said that one company’s failure to meet the deadline resulted in a seizure of $24 million of their unapproved drugs.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, said that doctors and patients are often unaware that not all drugs on the market are backed by the FDA. “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,” she said.
If you are concerned that you may be taking any unapproved medications, refer to the FDA’s Unapproved Drugs Web page, which includes a list of manufacturers of these products. If you find that you are taking an unapproved drug, there are plenty of approved brands of the same medication. The FDA is confident that there will be no shortage of these pain medications.
Since the FDA began its crackdown on unapproved drugs, 200 firms and 900 drug products have been subject to FDA actions.
Tags: narcotics, oxycodone addiction
