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FDA alerts over Tussionex cough medicine

The US Food and Drugs Administration announced on March 11 that reports have been received about life-threatening side effects of Tussionex.

The US Food and Drugs Administration (FDA) announced on March 11 that reports have been received about life-threatening side effects of Tussionex.

Tussionex pennkinetic extended-release suspension, a UCB manufactured cough medicine, has caused death in patients including children under the age of 6-years-old.

Complications with the medication have arisen from failure to follow prescription and dosage information.

The FDA said: "The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved aged group of 6-years-old and older, more frequently than the labelled dosing interval of every 12 hours."

"Patients have administered the incorrect dose due to misinterpretation of the dosing directions and use of inappropriate devices to measure the suspension."

New guidance and prescription is being drafted by UCB in cooperation with the FDA to prevent further incidences of adverse events related to the use of Tussionex.

Original prescription information did not permit the use of Tussionex in children under 6-years-old, but it was contraindicated for that age group in 2007.

Guidelines for the use of Tussionex with children under 6-years-old are stringent due their susceptibility to life-threatening and fatal respiratory depression.

UCB sated on it website that it is committed to ensuring that Tussionex is used in accordance with clear prescription information.

Healthcare professional were sent letters at the time of the 2007 contraindication by UCB informing them of the changes made.

UCB said: "Tussionex was approved by the FDA in 1987 and has been used by millions of patients since then."

12th March 2008

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