A July 4 statement issued by Pfizer said that the company is discussing with the FDA a protocol for a meta-analysis of Pfizer’s clinical trial data to evaluate the drug’s cardiovascular risk. It also says that the company stands by the risk-benefit profile of varenicline and expressed concerns about the reliability of the meta-analysis, which includes the way cardiovascular events were counted and the small number of events that were the basis of the conclusions.
Serious adverse events associated with varenicline should be reported to the FDA’s MedWatch program online or at 800-332-1088.