The Food and Drug Administration (FDA) may issue a revision of its warning on Pfizer's controversial smoking-cessation drug Chantix, the Wall Street Journal reported Oct. 23.

Just a few months after Pfizer relaunched television advertisements for the drug, the Institute for Safe Medication Practices released a report highlighting 1,001 recent, serious incidents involving Chantix. Of these, 15 were related to traffic accidents and 52 were connected to blackouts.

"The most alarming thing about the numbers is the increase in loss of consciousness like a blackout, and the sudden [temporary] loss of vision," said report co-author Curt Furberg, a professor at Wake Forest University's medical school. "That's potentially very dangerous for everyone, as the traffic-accident numbers show."

"The FDA is reviewing these reports to see if current labeling related to accidents after varenicline [Chantix] is adequate," the government agency said in a statement. The FDA issued a warning last spring after the Institute published a report linking 173 accidents to the drug, and numerous cases of psychiatric side effects were documented.

Pfizer defends the product, saying that these reports "are often unverifiable and lack sufficient medical information to draw any conclusions." Pfizer maintains that Chantix is "an important treatment option to help patients stop smoking."