According to adverse drug event reports received by the FDA, there may be a connection between the use of Chantix and diabetes. The stop smoking drug has been linked with a number of reports involving loss of glycemic control, which includes new onset diabetes.
While studies have not firmly established that Chantix causes diabetes, sufficient reports of problems associated with the use of the drug to raise substantial concerns within the medical community.
Chantix (generic varenicline tartrate) is a prescription drug sold to help people quit smoking. It was approved by the U.S. Food and Drug Administration in May 2006 and has become one of the fastest growing medications in the country.
Within the first two years the drug was on the market, concerns started to surface about a possible connection between Chantix and a variety of serious and potentially life threatening side effects.
By late 2007, Chantix was one of the most frequently listed drugs associated with a wide variety of serious adverse event reports received by the FDA. This led an independent consumer watchdog group, The Institute for Safe Medication Practices, to conduct a detailed analysis of all reported problems associated with Chantix.
An examination of adverse event reports received by the FDA between May 2006 and December 2007 revealed at least 544 reports suggesting Chantix side effects may have caused a loss of glycemic control, including a number of cases that contained symptoms and lab tests consistent with onset of diabetes. This likely represents only a small portion of the true number of adverse events experienced by users, as it is generally accepted that only about 1% to 10% of all serious events are reported to the FDA.
While many of the reported adverse events in this category were a result of weight gain or weight loss, which could be expected among a population of people quitting smoking, a large number of the cases had classic indications of new onset diabetes mellitus from Chantix. This included reports of elevated blood glucose, hunger, thirst and frequent urination.
The study does not establish a firm causative link between Chantix and diabetes, but the reports did provide a concerns about a possible association among experts, doctors and patients.
Although the lawyers at Saiontz & Kirk, P.A. are no longer reviewing potential cases for side effects of Chantix, lawsuits were previously pursued on behalf of individuals who committed suicide, attempted suicide or suffered other psychiatric injury. The complaints alleged that Pfizer failed to adequately warn about the risk of these injuries prior to July 2009. Thousands of lawsuits were filed nationwide. As of 2013, most of the litigation has settled and Saiontz & Kirk, P.A. is not accepting new cases.