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FDA Issues Strong Warning on Tussionex Cough Medicine

March 12, 2008

The U.S. Food and Drug Administration (FDA) issued an alert Tuesday warning parents and doctors that the prescription cough medicine Tussionex, made by Belgium-based UCB, may have fatal side effects if used incorrectly.

The FDA issued its alert after receiving reports that doctors may be over-prescribing the drug, and after reviewing reports of health problems and deaths among children and adults who took Tussionex.

The report stated that some people may be taking the Tussionex Pennkinetic Extended-Release Suspension more frequently than the recommended interval of once every 12 hours.  Others may be giving it to children under age 6, which is not approved, the FDA said.  

Tussionex contains the narcotic pain reliever hydrocodone, which taken in excess can cause life-threatening respiratory problems.

Since its approval in 1987, five deaths have been reported among children under 6 who took Tussionex, UCB company spokesman Eric Miller said last Friday. He said the company had proposed a stronger warning for the medicine following the reports of the deaths.

Speaking Tuesday, Miller reiterated that the number of deaths in those under six remained at five.  

The FDA urged doctors and patients to follow prescribing instructions precisely, and to only use medical syringes or other devices designed to measure liquid medications since household spoons vary in size.

“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Dr. Curtis Rosebraugh, acting director of the FDA office that regulates prescription cough medicines, in a statement.

The FDA statement said UCB will update the Tussionex label to address the concerns.

“The FDA’s alert is fully in line with our efforts to make sure this product is properly used,” a UCB spokeswoman told Reuters, adding the company had already taken steps to clarify the label of the product last year.

The spokeswoman said she did not anticipate that UCB would withdraw the product as the FDA alert only pertained to improper use of the medicine, adding that Tussionex sales in the U.S. totaled 114 million last year.

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U.S. Food and Drug Administration (FDA)

Read the FDA alert




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