Europe's main drug regulator has lifted a 7-year-old warning about possible suicidal risks from Chantix, Pfizer's smoking-cessation pill.
The European Medicines Agency's ruling could boost sales of Champix, the drug's name in Europe, by reassuring doctors and their patients trying to quit smoking that the prescription medicine doesn't have dangerous psychiatric side effects.
The EMA's decision, announced Monday by Pfizer, comes after New York-based company performed an 8,144-patient, 16-country study, which found users had no elevated risk of suicides, suicide attempts or suicidal thoughts. Anecdotal reports of such risks had led both the EMA and the U.S. Food and Drug Administration to require stringent warnings on the medicine.
The FDA is reviewing the study and hasn't decided whether the warning can be removed from U.S. Chantix package inserts.