FDA approves new Chantix medication guide
BETHESDA, Md. The medication guide for a new anti-smoking drug has received approval from the Food and Drug Administration.
The FDA on Friday approved the medication guide for Pfizer’s drug varenicline, marketed as Chantix.
An FDA alert from February stated that mental side effects in some patients taking Chantix have included depression, agitation, suicidal thoughts and both attempted and completed suicide.
In light of the side effects, the FDA recommended that Pfizer place safety information under the warnings and precautions sections of the drug’s prescription information. Information about mental side effects appears in the medication guide.