3 Min Read
WASHINGTON/BRUSSELS (Reuters) - U.S. health officials warned parents and doctors about Tussionex, the prescription cough medicine, saying it may have fatal side effects if used inappropriately.
The U.S. Food and Drug Administration issued an alert on Tuesday saying it had received reports that indicate doctors may be over prescribing the cough medicine made by UCB.
Some people also are taking the medicine, Tussionex Pennkinetic Extended-Release Suspension. more frequently than every 12 hours, the recommended time interval, or giving it to children under age 6, the FDA said. Tussionex is not approved for children younger than 6 years old.
The FDA said it had received numerous reports of health problems and deaths among children and adults who took Tussionex, which contains the narcotic pain reliever hydrocodone. Too much hydrocodone can cause life-threatening breathing problems.
Five deaths have been reported among children under 6 who took Tussionex since its approval in 1987, company spokesman Eric Miller said on Friday. He said then that UCB has proposed a stronger warning for the medicine following the reports of the deaths.
Miller said on Tuesday the number of deaths reported to the company for that age group remained at five.
The FDA urged doctors and patients to follow prescribing instructions and to only use a medical syringe or other device designed to measure liquid medications. Household spoons vary in size and should not be used, the FDA said.
"There is a real and serious risk for overdosing if this medication is not used according to the labeling," Dr. Curtis Rosebraugh, acting director of the FDA office that regulates prescription cough medicines, said in a statement.
UCB, based in Belgium, will update the Tussionex label to address the concerns, the FDA's statement said.
"The FDA's alert is fully in line with our efforts to make sure this product is properly used," a spokeswoman for UCB told Reuters, adding the company had already taken steps to clarify the label of the product in 2007.
The spokeswoman said she could not see any reason why UCB would withdraw the product as the FDA alert only addressed an improper use of the medicine.
Tussionex sales in the U.S. totaled 114 million euros ($176 million) in 2007, the spokeswoman added.
The FDA alert was posted here
Reporting by Lisa Richwine and Julien Ponthus, editing by Tim Dobbyn, Leslie Gevirtz