This site is intended for health professionals only!

Published on 23 November 2007

Share this story:

FDA launches probe into Chantix

teaser

US government scientists are investigating whether a drug used to help people stop smoking also increases suicidal thoughts and violent behaviour.

The Food and Drug Administration (FDA) said it has received reports of mood disorders and erratic behaviour among patients taking Chantix, which is manufactured by Pfizer.

The FDA said it is still gathering information about the drug, which won regulatory approval last year, but advised doctors to closely monitor patients taking Chantix for behaviour changes.

The agency said the changes have often been reported within days or weeks of people first taking the drug.

Pfizer said it has added information about the reports to the product’s label, but stressed “there is no scientific evidence establishing a causal relationship between Chantix and these events.”

The firm added that there were no suicides in a 5,000-patient study of the drug.

Pfizer said it has also submitted reports to the FDA about drowsiness among Chantix patients that interfered with their ability to drive.

The firm said that clinical studies of the drug showed there was no significant difference in drowsiness between patients taking Chantix and those taking a dummy pill.

Copyright © PA Business 2007

Pfizer

Food and Drug Administration



Most read




Latest Issue

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine