U.S. health officials issued an alert on Tuesday about reports of life-threatening side effects and deaths linked to inappropriate use of UCB SA’s prescription cough medicine Tussionex.
The reports indicate doctors sometimes are prescribing, and patients sometimes taking, more than the recommended dose of Tussionex Pennkinetic Extended-Release Suspension, the Food and Drug Administration said.
Some people also are taking the drug 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.
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 or can be fatal.
Five deaths have been reported among children under 6 who took Tussionex since its approval in 1987, UCB 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. He could not immediately be reached on Tuesday.
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.
