FDA Tells Nine Drug Makers To Stop Selling Unapproved Narcotics

Kate Traynor

BETHESDA, MD 31 March 2009—FDA announced today that manufacturers of an assortment of oral solutions and tablets containing narcotics have 60 days to cease making the products, which are considered unapproved drugs.

"Today FDA warned nine companies to stop marketing 14 unapproved versions of high-concentrate morphine sulfate oral solutions and unapproved immediate-release tablets of morphine sulfate, hydromorphone, or oxycodone," said Debra Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research.

Autor and her colleagues told reporters during a telebriefing that these medications were targeted not because of specific reports of safety problems but because the manufacturers have not provided FDA with required data on the products' safety, effectiveness, purity, and quality.

"We don't know it they're safe and effective, so that poses a risk for patients," Autor said.

She said the enforcement action "does not affect FDA-approved versions of these drugs."

In some cases, the manufacturers cited in the announcement also make FDA-approved versions of one or more products targeted by the agency. Autor said FDA believes that the removal of the unapproved narcotics will not affect patient care, because the supply of alternatives is strong enough to meet demand.

FDA expects previously shipped batches of the banned products to remain on pharmacy shelves temporarily. The agency has given drug distributors 90 days to cease shipping the products.

Autor said today's action is the latest in a series of enforcement initiatives FDA has taken since 2006, when the agency began targeting for removal products that have not undergone the approval process.

FDA in 2007 announced that it would take action against more than 200 unapproved hydrocodone-containing antitussive products labeled for use in children under six years of age.

Medications that have been targeted under the unapproved drugs initiative include products containing colchicine, quinine, trimethobenzamide, ergotamine, or carbinoxamine.

Autor said FDA believes its "aggressive" policies toward makers of unapproved drugs are prompting manufacturers to seek agency approval of such products. She said the agency will continue its efforts to remove unapproved drugs from the market.