Wednesday, January 03, 2018 by Earl Garcia
Pfizer’s flagship smoking cessation drug varenicline, sold under the brand names Chantix in the United States and Champix in Canada and Europe, may do more harm than good as recent research published in the American Journal of Respiratory and Critical Care Medicine showed that the medication was associated with an increased likelihood of suffering from cardiovascular conditions.
A team of Canadian health experts examined the medical records of 56,851 new users of varenicline between September 2011 and February 2015 to carry out the study. The researchers observed that 4,185 of patients experienced one or more cardiovascular events, while 4,720 patients suffered neuropsychiatric events that lead to an emergency department visit. The scientists also found that patients who took varenicline had a 34 percent increased risk of being sent to the emergency department or getting hospitalized due to cardiovascular events.
“Quitting smoking greatly reduces a person’s chances of developing heart disease and cancer and has many other health benefits. Previous studies regarding the safety of varenicline have been conflicting and most examined people with relatively similar characteristics and backgrounds in highly controlled settings. The findings should be used to help people make an informed decision about whether they should take varenicline based on accurate information about its risks as well as its benefits,” lead author Dr. Andrea S. Gershon said in a Science Daily article.
A 2011 study published in the journal PLoS ONE also demonstrated that the smoking cessation drug was particularly harmful to mental health. Scientists at the Wake Forest Baptist Medical Center, Harvard Medical School, the Institute for Safe Medication Practices, and Johns Hopkins University School of Medicine pooled data from the U.S. Food and Drug Administration‘s Adverse Event Reporting System as part of the study.
The researchers examined more than 3,000 case reports of self-injurious behavior or depression linked to varenicline and other smoking cessation medications. The scientists observed that 90 percent of all reported suicides linked to smoking cessation drugs implicated varenicline. Likewise, the research team found that varenicline use was associated with an eight-fold increased risk of reported suicidal behavior or depression in patients.
“While suicidal behavior or depression appear to be a prominent side effect of varenicline, they are by no means the only safety issues. Varenicline has been associated with aggression and violence in three studies and carries a warning about this behavior. Its effects on vision, cognition and motor control, and other risks have led to its being banned for airline pilots, air traffic controllers, military pilots and missile crews, and restricted for truck drivers,” lead author Thomas J. Moore told Science Daily online.
Another study featured in the Journal of the American Medical Association showed that the apparently problematic smoking cessation drug did not fare better than other nicotine replacement treatments in making smokers quit the habit. (Related: Prescription drugs declared “one of the most significant perils to human health” by British medical journal)
Researchers examined the effects of three smoking cessation treatments on more than 1,000 patients. The volunteers were subsequently divided into three groups. One group received a nicotine patch alone, another took a Chantix pill, while a third group had a combination of a patch and nicotine lozenge. The scientists observed that the six-month quit rates among volunteers were 23 percent for the nicotine patch group, 24 percent for Chantix group, and 27 percent for the patch and lozenges group.
The experts also found that the quit rates at one year were 21 percent for the patch group, 19 percent for the Chantix group and 20 percent for the patch and lozenges group. Furthermore, the research team found that patients who took Chantix experienced more side effects. The results showed that 29 percent of the patients suffered nausea, while 23 percent reported having vivid dreams and 22 percent experienced insomnia.
Be on the look out for the latest news in adverse drug reactions at BigPharmaNews.com.