Pfizer Inc. (NYSE:PFE) unsuccessfully tried to stop black box warning on its stop-smoking drug known as Chantix. Boxed warning is typically used where most serious risks have been noted. The FDA maintained that Chantix exposes users to some serious psychiatric side effects, which should be known to the public.
According to FDA, Chantix, chemically known as varenicline, can cause seizures and make users extremely aggressive. The risks have been noted in some users of the drug. An update to the label of the drug was approved late last year but the health agency decided to move further by making a public notification about the side effects.
The FDA, which approved Chantix in 2006, hopes that the new information about the risks of using the drug will enable patients to make informed prescription decisions.
Psychiatric side effects
Some other psychiatric risks associated with the use of Chantix include agitation, hostility and thoughts of suicide. The FDA has lighted the warning about these risks by a black box. Pfizer Inc. (NYSE:PFE) sought to have the black box warning removed but the FDA declined.
According to Pfizer Inc. (NYSE:PFE), its own tests have not shown that the drug bears any risks that warrant black box warning. However, the FDA stated that it will keep the boxed warning until further study into the safety of the drug is concluded. Additionally, the health agency said that study data that it has already looked at was so limited that it could not draw a reliable conclusion.
Additional safety study
Pfizer Inc. (NYSE:PFE) is conducting further safety study of Chantix and the results are expected to come out later this year. However, the FDA will keep the boxed warning on the drug until such a time when the additional trial is concluded and more facts about the safety of the drug are obtained.
Chantix brought in nearly $647 million of revenue last year. The black box warning could hurt future sales of the drug.
Pfizer Inc. (NYSE:PFE) is currently trading at $34.06 after gaining 0.09%