Controversy
On Thursday, May 22, 2008, The New York Times reported that the U.S. Federal Aviation Administration (F.A.A.) had announced the day before a ban on the use of Chantix (varenicline tartrate) for both pilots and air traffic controllers, due to concerns with possible adverse neuropsychiatric effects which could be detrimental to public safety.[10]
On Sunday, May 25, 2008, The Los Angeles Times reported that over 2 dozen traffic accidents had been linked to Chantix and reported to the FDA. Warnings had previously been issued by Pfizer regarding the risks of Chantix while driving. However, these warnings have largely been ignored by doctors and patients.[11]
On Tuesday, June 17, 2008, The Washington Times reported on its Front Page that the United States Department of Veterans Affairs was testing Chantix on war veterans with Post Traumatic Stress Disorder without properly warning them of the side effects, and that in one case a veteran was almost killed when he had a psychotic episode and threatened police officers.[12]
On October 23, 2008, the Institute for Safe Medication Practices issued an analysis of prescription drug-related injuries reported to the FDA during the first quarter of 2008. According to the report, varenicline had more reported incidents than any other drug, with 1001 new cases of adverse effects and 50 more deaths reported (Heparin, the drug with the second highest number of injury reports, had 779 new cases, most of which were connected to a contaminate inadvertently introduced into the drug in early 2008). In comparison, the ISMP reported that in the first quarter of 2008 there were 17 serious injury reports for nicotine-replacement products, and 44 reports for bupropion (sold as Zyban as a smoking cessation medication). Varenicline did not rank in the ten drugs with the most related deaths, but did rank first in reports of suicide or self-injury, with 228 reports citing these effects. The ISMP noted that the high number of varenicline-related injury reports may be related to the publicity surrounding the medication's potential side effects. [13]
On February 4, 2009, Health Canada announced that it had received more than 800 complaints from Canadian users, many of them reporting mood swings, depression or suicidal thoughts.[14]