FDA Acts Against Unapproved Narcotic Drugs

FDA Acts Against Unapproved Narcotic Drugs

By John Gever, Senior Editor, MedPage Today
Published: March 31, 2009

SPRING, Md., March 31 — The FDA has taken steps to pull 14 unapproved
painkillers containing immediate-release morphine sulfate, oxycodone,
and hydromorphone from the market.

The agency has warned nine
companies that make the unapproved products to stop manufacturing them
within 60 days and to cease distribution within 90 days.

Among the drugs affected
by the enforcement action are two branded products containing morphine
sulfate and oxycodone (Roxanol and Roxicodone, respectively) as well as
generic versions of the three painkillers.

All the affected products are tablets or oral solutions.

capsules were not among the products targeted in the action, Deborah
Autor, J.D., director of the compliance office in FDA's Center for Drug
Evaluation and Research, emphasized at a press briefing today.

Extended-release opioids were also unaffected by today's action.

who have been taking the unapproved medications are urged to seek
prescriptions for equivalent or similar approved products.

"We believe [the action] will not disrupt patient care," Autor said.

She said some patients may have to switch to products not exactly identical to the unapproved drugs.

of the letters cited immediate-release 20 mg/mL morphine sulfate
solutions. There is no approved version of morphine solution at that
concentration, although 20 mg/5 mL is available.

Autor said supplies of
alternative products were sufficient to replace the unapproved
products, even though immediate-release oxycodone appears on the FDA's
most recent drug-shortage list, updated March 25.

"There will be no shortage for consumers," she said.

companies told to pull their products are Mallinckrodt, Boehringer
Ingelheim Roxane, Roxane Laboratories, Glenmark Generics, Lannett
Company, Lehigh Valley Technologies, Physicians Total Care, Xanodyne
Pharmaceuticals, and Cody Laboratories.

Autor said the companies must submit responses to the warning letters within 15 days or face sanctions.

a press briefing announcing the action, Autor said the companies may
seek approval for the products, but in the meantime they still must be
pulled from the market.

About David S Klein, MD 149 Articles
David S. Klein, MD, FACA, FACPM was born in Washington, DC, and was raised in Chevy Chase, Maryland. He completed his undergraduate education at the University of Maryland with degrees in Chemistry and Psychology. Medical School was completed at the University of Maryland at Baltimore, followed by Internship in General Surgery at the University of North Carolina and Residency in Anesthesiology at the Duke University, Durham, North Carolina. Dr Klein has been practicing medicine since 1983, concentrating in Pain Medicine, Minimally Invasive Medicine and Surgery, and Neuroendocrinology. Earning Board Certification in Anesthesiology, Dr. Klein was elected Fellow in the American College of Anesthesiology, and he was elected Fellow in the American College of Pain Medicine. He is currently an adjunct Associate Professor at the University of Central Florida, School of Medicine. He has focused his private practice on treating patients with hormone imbalance issues, nutritional deficiency related medical problems as well as pain related issues and impairment. With a highly-complex, CLIA licensed laboratory in-house, he has been able to provide rapid-turn around analysis efficiently and cost-effectively. Lecturing extensively nationally as well as internationally, Dr. Klein has authored many articles on topics relating to pain, injury and nutritionally modulated illness. His radio show, “Pain Free Living,” received top ratings during the 6 years it was on the air. Currently practicing in Longwood, Florida, Dr. Klein practices entirely in the office setting.