The European Medicines Agency (EMEA) is probing the safety of the antismoking drug Champix (varenicline) amid reports it increases depression and suicide.
The regulator has asked manufacturer Pfizer to submit more information about the possible side-effects from taking the medication.
EMEA spokeswoman Monika Benstetter said: “Based on a preliminary review of patient reports, our committee concluded this could signal a problem.”
Champix was licensed for sale as a smoking cessation aid in the EU last September.
The drug works by binding to nicotine receptors in the brain, and also works by reducing the symptoms of withdrawal.
At a meeting this month, the EMEA concluded that “there is a need to update the product information for Champix to warn doctors and patients that depression has been reported in patients who are trying to stop smoking using Champix”.
The latest decision follows reports from the US in November, where the drug is sold as Chantix, that at least one patient died while taking it.
Pfizer said that it is working closely with the EU agency to review cases of depression and suicidal thoughts in patients taking Champix.
But a statement added: “There is no scientific evidence establishing a causal relationship between Champix and these reported events.”
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