Yesterday the FDA (U.S. Food and Drug Administration) warned the public that Pfizer Inc’s Chantix, their newest quit-smoking drug, has been linked to the occurrence of seizures. They also warned that some patients who drink alcohol while taking Chantix can become significantly aggressive or even black out.
The FDA also stated that it had approved a revision to the drug’s label last September. However, they issued the public notice to make certain that users are aware of the specific changes “and can consider this new information when making prescribing decisions.” Normally, warnings such as these are made when they change the labels.
Chantix, or varenicline as it is chemically-known, was green-lighted several years ago in 2006. The U.S. Food and Drug Administration later updated and revised the label. The new label included a specific “black box’ warning.
The FDA reserves their black box warnings for only the most serious risks. In the case of Chantix the warning concerns several neuropsychiatric side effects such as agitation, hostility and even suicidal thoughts.
Pfizer has already requested that the agency delete the black box. They claim their research reveals no connection between their product and the psychiatric side effects in question. This past October the U.S. Food and Drug Administration advisory committee suggested retaining the black box warning until an ongoing safety study was completed.
Yesterday the agency announced it had reviewed a number of studies including Pfizer’s analysis. The research reportedly had limitations that left the FDA incapable of coming to a truly reliable conclusion.
Pfizer is currently mounting a new safety study of Chantix which they report brought in $647 million in revenue last year. The new results are expected late this year. The FDA concluded the black box would remain in place at least until the new trials are completed.
FDA Warns Of Alcohol, Seizure Risk With Pfizer’s Chantix