Drug Companies Receive FDA Warnings for Selling Unapproved Narcotics

The Food and Drug Administration (FDA) has issued warnings to nine companies to stop manufacturing and shipping unapproved narcotic pain medication, Reuters reported March 31.

Boehringer Ingelheim’s Roxane Inc unit, Covidien Ltd’s Mallinckrodt unit and Glenmark Pharmaceuticals all received notice to stop manufacturing unapproved versions of prescription drugs containing morphine, hydromorphone, or oxycodone within 60 days. The companies were ordered to stop shipments within 90 days or risk seizure and legal action.

CNN reported March 31 that FDA officials said the therapeutic claims about the drugs had not be proven.

The FDA said it did not anticipate a shortage of pain medication , noting that there are enough other FDA-approved medications with those active ingredients. The FDA moved to stop the sale of unapproved prescription drugs in 2006, estimating that two percent of prescriptions in the U.S. are filled with unapproved drugs.

“Consumers have a right to expect that their drugs meet the FDA’s safety and effectiveness standards,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “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.”