FDA issues Tussionex safety alert

Mar 11, 2008

The U.S. Food and Drug Administration issued a safety alert, saying incorrect usage of a specific cough medicine can result in serious health risks.

The FDA said its alert concerns the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension -- a prescription cough medicine containing hydrocodone, a narcotic ingredient and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of 6 and should be given no more frequently than every 12 hours.

"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's Office of Drug Evaluation II.

The FDA said adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children, resulting from taking more than the recommended dose or taking the medication more frequently than every 12 hours.

The federal agency said reports also show Tussionex is sometimes prescribed or given to children younger than 6 years, for whom the medication isn't approved.

Tussionex Pennkinetic Extended-Release Suspension is manufactured by UCB Inc. of Smyrna, Ga.

Copyright 2008 by United Press International

Explore further: FDA clears Novo Nordisk's weight loss drug Saxenda

add to favorites email to friend print save as pdf

Related Stories

NASA image: Frosty slopes on Mars

50 minutes ago

This image of an area on the surface of Mars, approximately 1.5 by 3 kilometers in size, shows frosted gullies on a south-facing slope within a crater.

Recommended for you

Express Scripts turns to AbbVie in huge hepatitis C deal

Dec 22, 2014

The nation's largest pharmacy benefits manager is throwing its weight into the fight over high-cost hepatitis C drugs with a coverage restriction that might ultimately lower prices and improve patient access ...

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.