The Belgian pharmaceutical group UCB SA has proposed a stronger warning for its prescription cough medicine Tussionex following reports that five young children died, a company spokesman said on Friday.
Five deaths have been reported among children under 6 who took the medicine since its approval in 1987, UCB spokesman Eric Miller said. The drug, known as Tussionex Pennkinetic Extended-Release Suspension, is approved only for adults and children age six and older.
The prescribing information for doctors specifically says it should not be used in children younger than 6. Miller said the company felt that information should be strengthened and proposed new language to the U.S. Food and Drug Administration.
“We recently proactively reached out to the FDA to update the Tussionex label,” Miller said.
The drug is “safe and effective when used as directed,” he added.
Tussionex is one of eight prescription cough medicines that contain the narcotic pain reliever hydrocodone, Miller said.
The Wall Street Journal reported on Friday that the FDA planned to issue an alert about Tussionex after numerous reports of adverse events including some deaths. The Journal said the FDA had received reports of patients taking higher doses or more frequent doses than recommended.
FDA spokeswoman Susan Cruzan said the agency officials were ”aware of these safety concerns and are working to address them.”
“We plan to communicate our recommendations to the public as soon as possible,” she said.