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The EMA has confirmed that it will continue to back Champix, the smoking cessation prescription medication, despite concerns raised by a recent study.
The controversial study, which took place earlier this year at the John Hopkins University School of Medicine in the United States, appeared to indicate that Champix heightened the risk of heart attacks and strokes by 72%. There have also been concerns raised about psychiatric side effects, including depression and suicidal ideation. In May, the French government took the step of removing the medication from the list of reimbursable treatments in France, meaning it would not be covered by health insurance, in response to these concerns.
However, the EMA has issued a statement confirming that the benefits of Champix in relation to its ability to aid smoking cessation outweigh the “slight reported increase in cardiovascular events.” The Committee for Medicinal Products for Human Use (CHMP) worked with the Pharmacovigilance Working Party to analyse the study, in order to determine how it affected the benefit-risk balance of Champix. They raised a number of concerns about the study itself, including “the lower number of events seen, the types of events counted, the higher drop-out rates in people receiving placebo, the lack of information on the timing of events, and the exclusion of studies in which no-one had an event.”
Champix was first authorised for use in the European Union for the purpose of aiding smoking cessation in 2006. The product information currently available from Pfizer does include information on potential cardiovascular side effects. The CHMP has requested that Pfizer include further information on this in their product information.