Pfizer says EMA lifts warning on its smoking cessation drug Champix

pharmafile | May 24, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing |ย ย Champix, EMA, Pfizer, anti-smoking, drug trialย 

US pharma giant Pfizer (NYSE: PFE) said the European Medicines Agency has lifted a warning on its anti-smoking drug Champix (varenicline) following a study showing the therapy did not appear to  increase the risk of neuropsychiatric side effects.

Champix is approved as an effective therapy for aiding smokers quit however, the European Medicines Agency added a black triangle warning following reports linking it to agitation, aggression, panic, anxiety, depression and suicidal thoughts.

The warning required additional safety monitoring for people taking the drug.

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Rory O’Connor, Pfizer’s chief medical officer, said: “The new safety and efficacy information in the European label further supports the importance of Champix as a treatment option for healthcare providers and for those who are trying to quit smoking.”

Pfizer said the European regulators adopted a decision to change the label in the light of reassuring results from a large study, published in The Lancet in April.

Pfizer’s medicine, which has been prescribed to millions of patients around the world, also carries a black box warning in the US relating to neuropsychiatric adverse events.

Chantix was approved by the US Food and Drug Administration in May 2006 as a prescription medication that helps to stop smoking. 

Anjali Shukla

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