March 7 (Bloomberg) -- UCB SA's prescription cough medicine Tussionex has prompted ``safety concerns'' at the U.S. Food and Drug Administration, an agency spokeswoman said.

The FDA is working to resolve the concerns and plans to ``communicate our recommendations to the public shortly,'' FDA spokeswoman Susan Cruzan said today in an e-mail. The Belgian drugmaker recently contacted the FDA about updating existing precautions in prescribing information for Tussionex to ensure proper dosing, company spokesman Eric Miller said.

The FDA has received reports of ``numerous'' side effects and ``some deaths'' in patients who took more than the recommended dose of Tussionex, the Wall Street Journal reported today on its Web site. The FDA also has received reports of use by children under age 6, which isn't recommended, the Journal said.

``Tussionex is safe and effective when taken as directed,'' Miller said today in a phone interview.

UCB has received five reports of deaths in children younger than 6 since Tussionex was approved in 1987, Miller said. The drug is one of eight prescription cough medicines on the U.S. market containing hydrocodone, a potent narcotic that can be deadly if taken in large quantities, he said.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: March 7, 2008 18:19 EST