EMEA Asks Pfizer To Update Champix Warnings

The European Medicines Agency (EMEA) said on Friday that Pfizer’s Champix, a drug used for smoking cessation in adults, should carry a side effect warning about the high risk of suicide attempts among patients.

The EMEA said that there is an urgent need to provide updated warnings to doctors and patients to increase awareness of cases of suicidal ideation and suicide attempts reported in patients using Champix (varenicline). The pill is sold as Champix in Europe and Chantix in the United States.

The safety of Champix which was first authorized in the European Union (EU) in September 2006 has been closely monitored by The Committee for Medicinal Products for Human Use (CHMP). All detrimental reactions for Champix have been analyzed by the CHMP on a regular basis as part of routine pharmacovigilance activities. Cases of suicidal ideation and suicide were reviewed in July, October and November 2007.

At its December 2007 meeting, the CHMP said that Pfizer needs to update the product information to warn doctors and patients that depression has been reported among patients who are trying to quit smoking by using Champix. This depression may further lead to suicidal ideation and suicide attempt.

The CHMP has requested Pfizer to submit a variation to the marketing authorisation for Champix before 19 December 2007 to implement these changes to the product information.

It should be noted that only last month, The Food and Drug Administration in the U.S. had issued a warning for Chantix, citing one death, which may be linked to the drug’s intake.

However, the world's largest pharmaceutical company, Pfizer, said that there is no scientific evidence that connects its drug to the reported events. The company also said that it is working closely with the European watchdog to review case histories.

Pfizer said, “ The clinician should be aware of the possible emergence of depressive symptoms in patients undergoing a smoking cessation attempt, with or without treatment, and should advise patients accordingly."

The news of the European regulators highlighting concerns about the safety of Champix led to a fall in shares of Pfizer Inc. on Friday. The drug had a revenue of $241 million in the third quarter of 2007.