Cytisine analogs led to varenicline at Pfizer.Varenicline received a "priority review" by the US FDA in February 2006, shortening the usual ten-month review period to six months because of its demonstrated effectiveness in clinical trials and perceived lack of safety issues. The agencys approval of the drug came on May 11, 2006. On September 29, 2006, it was approved for sale in the European Union.On September 16, 2021, Pfizer announced a recall of "all lots of its anti-smoking treatment, Chantix [Varenicline], due to high levels of cancer-causing agents called nitrosamines in the pills". This followed a July 2, 2021 announcement by the FDA that it was "alerting patients and health care professionals to Pfizers voluntary recall of nine lots of the smoking cessation drug" and further recalls by Pfizer on July 19 and Aug. 8. On June 24, Pfizer had paused distribution of Chantix worldwide; "[t]he distribution halt [wa]s out of an abundance of caution, pending further testing, the company said in an email. According to the Pfizer Inc. 2020 Form 10-K Annual Report, high-revenue products by the company include[d] Chantix/Champix (varenicline) to treat nicotine addiction, [which] had $919 million in 2020 revenues.In October 2021, US FDA approved Oyster Point Pharma to market Tyrvaya as a new route of varenicline administration through nasal spray for the treatment of dry eye disease. References
External links
"Varenicline". Drug Information Portal. U.S. National Library of Medicine.
Incidence of nausea is dose-dependent: incidence of nausea was higher in people taking a larger dose (30%) versus placebo (10%) as compared to people taking a smaller dose (16%) versus placebo (11%). Depression and suicide
In 2007, the US FDA had announced it had received post-marketing reports of thoughts of suicide and occasional suicidal behavior, erratic behavior, and drowsiness among people using varenicline for smoking cessation. In 2009, the US FDA required varenicline to carry a boxed warning that the drug should be stopped if any of these symptoms are experienced.A 2014 systematic review did not find evidence of an increased suicide risk. Other analyses have reached the same conclusion and found no increased risk of neuropsychiatric side effects with varenicline. No evidence for increased risks of cardiovascular events, depression, or self-harm with varenicline versus nicotine replacement therapy was found in one post-marketing surveillance study.In 2016 the FDA removed the black box warning. People are still advised to stop the medication if they "notice any side effects on mood, behavior, or thinking." Cardiovascular disease
In June 2011, the US FDA issued a safety announcement that varenicline may be associated with "a small, increased risk of certain cardiovascular adverse events in people who have cardiovascular disease. "A prior 2011 review had found increased risk of cardiovascular events compared with placebo. Expert commentary in the same journal raised doubts about the methodology of the review, concerns which were echoed by the European Medicines Agency and subsequent reviews.