Pfizer, maker of the anti-smoking drug known as Chantix, expects a major drop in sales after the Food and Drug Administration (FDA) said users may experience suicidal thoughts. The FDA comments that patients with these illnesses were not included in the recent studies that were carried out for the drug’s approval in 2006.
According to the FDA, there are 500 Chantix cases where 39 have ended in suicides. Chantix may increase psychiatric illness with current patients and could even cause the illness to reoccur, the FDA said.
The FDA has asked Pfizer to this safety information to the warning and precautions section of the Chantix prescribing labeling. The Agency is working with the manufacturer to complete a patient’s Medication Guide.
Chantix was approved by the FDA in May 2006 to aid smoking cessation. The drug stimulates parts of the brain where nicotine affects to assist people who want to give up smoking. It can ease the nicotine withdrawal symptoms by blocking the gradual effects of nicotine from tobacco.
Sales of anti-smoking aid drug reached $280 million from Oct. – Dec. 2007.