Europe's main drug regulator has lifted a seven-year-old warning about possible suicidal risks from Champix, Pfizer's smoking-cessation pill.
The European Medicines Agency's ruling could boost sales of Champix, also known as Chantix, by reassuring doctors and would-be ex-smokers that the prescription medicine doesn't have dangerous psychiatric side effects.
The EMA's decision, announced on Monday by New York-based Pfizer, comes after an 8144-patient, 16-country study found users had no elevated risk of suicides, suicide attempts or suicidal thoughts.
Anecdotal reports of such risks led both the EMA and the US Food and Drug Administration in 2009 to slap their most-stringent warnings - a black triangle and a black box, respectively - on both Chantix and GlaxoSmithKline PLC's Zyban.
Australia's Therapeutic Goods Administration in December issued an advisory, updating the product information for the drug with a warning about the risk of psychiatric symptoms, particularly if alcohol is consumed at the same time.
"Psychiatric symptoms can involve changes in behaviour, thinking or mood and may include depression, anxiety, agitation, aggression, mood swings, self-harm, thoughts of self-harm, or seeing, hearing or sensing things that are not there," the advisory said.
The EMA now has removed the black triangle and changed the detailed prescribing information for Champix to state that a large patient study didn't find any increased risk.
Zyban is an antidepressant that reduces symptoms of nicotine withdrawal. Chantix, known chemically as varenicline, binds to brain receptors, blocking the ability of nicotine to bind to those sites and produce the feel-good chemical dopamine.
The EMA has not yet made any changes to its warning on Zyban, according to a GlaxoSmithKline spokeswoman.
GlaxoSmithKline and Pfizer jointly funded the huge safety study, ordered by the FDA.
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