EMA removes warning from Pfizer smoking cessation drug
- Pfizer's smoking cessation drug Champix will no longer carry a "black triangle" warning for neuropsychiatric side effects in Europe, after a clinical study showed no increase in risk, the company said Monday.
- The large post-marketing study demonstrated use of Champix (marketed as Chantix in the U.S.) did not increase suicidal behavior or other neuropsychiatric side effects, prompting the European Medicines Agency to lift its warning.
- The new data is under review by the FDA and other regulatory authorities, Reuters reports.
Chantix was approved by in the U.S. and Europe about a decade ago to help smokers quit. But reports of neuropsyhiatric side effects led regulators to require a large post-marketing study and add warnings about the drug's risk.
While the new study demonstrated Chantix's safety, sales of the drug have been hurt by the warnings required in both the U.S. and the E.U. The drug pulled in $671 million in global sales last year, down from $846 million in 2008.
Pfizer co-sponsored the Eagles study with GlaxoSmithKline, which also has a smoking cessation drug, Zyban, on the market. Conducted in 16 countries, Eagles evaluated Chantix and GSK's Zyban against a composite safety score. Results were published in The Lancet in April.
With the EMA decision to lift the warning, the drug's label will be updated in all 28 EU member states, plus Iceland, Norway, and Liechtenstein.
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