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EU Wants Warnings Added to Pfizer's Champix Drug


EU Wants Warnings Added to Pfizer's Champix Drug

December 14, 2007 - It is being reported that the European Union is requesting additional side effect warnings to be added to the label of Pfizer's anti-smoking pill Champix.

According to the European Medicines Agency, the new warnings must include increased risks of suicidal ideation and suicide attempts in people taking the drug.

The prescription drug was approved by the EU back in 2006 and since then has been monitored very closely by the Committee for Medicinal Products for Human Use.

Just last month, US regulators issued a warning pertaining to the drug, citing one death that may be linked to the useage of the drug.

In defense of their drug, Pfizer has stated that there is no scientific evidence linking their drug to any ill events.

"Clinicians 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 company added.

In the third quarter of 2007, $241 million worth of the Champix drug was sold by Pfizer.

The company has until December 19 to make the necessary changes to their drug labels.

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