FDA to warn about Tussionex side effects when taken at high doses or by young children

According to the Wall Street Journal, prescription cough medication Tussionex will receive a warning label update and an FDA alert as a result of side effects which could cause serious and potentially fatal injuries when it is taken at high doses or by children under 6. The FDA has received reports of a number of adverse events associated with the drug, including at least five deaths involving young children who never should have received the prescription cough medication.

Tussionex Pennkinetic Extended-Release Suspension is manufactured by UCB Inc., a Belgian pharmaceutical company. The cough medication contains hydrocodone, which is a narcotic that is also used as a pain reliever. When taken in large amounts, the cough suppressant can lead to breathing difficulties, slowed heart rate, extreme sleepiness or even death.

Tussionex, which was approved in 1987, is only supposed to be prescribed to adults and children six and older. The current prescribing information for doctors indicates the correct dosing and that the medication should not be used in children under 6. However, following reports of problems, a decision was made to strengthen the language and add clearer information about the risks of prescribing the medication at high doses or to young children.

The news about the cough medication problems comes just five months after several over-the-counter children’s cough and cold medicines were withdrawn from the market. Those cough medicines, which were designed for infants and children under two, were found to be ineffective in young children, and carried a risk of potentially fatal overdose