A new review of adverse event reports submitted to the FDA indicates that more reports of suicidal thoughts and behaviors are linked to the smoking cessation drug Chantix than any other medication sold in the United States. This report, issued by the Institute for Safe Medication Practices, comes just days after Pfizer asked the FDA to remove a “black box” warning added to the Chantix label in 2009, warning users about the risk of suicide and other psychiatric side effects associated with the drug. If you took Chantix in the past, and you have since suffered a major psychiatric side effect, like thoughts of suicide, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a knowledgeable Chantix attorney today.
According to the new ISMP report, between 2007 and 2013, Chantix was tied to 2,748 reports of suicide, homicidal ideation or self-injurious behavior, the next closet drug being Singulair, an asthma drug that was named in only 835 adverse event reports during the same time period. Rather than removing Chantix’s black box warning like Pfizer has requested, the ISMP report suggests that the Chantix side effect warnings should actually be strengthened, in order to more clearly highlight the potential risk of aggression, violent behavior and homicidal ideation associated with the smoking cessation medication.
Chantix (varenicline) is a prescription drug approved by the FDA in 2006 as a way to help people quit smoking, by inhibiting the positive feelings users associate with cigarettes. Shortly after Chantix was introduced however, serious concerns were raised about the possible psychiatric side effects of Chantix, following reports of users exhibiting unusually aggressive behavior and suicidal thoughts after taking the drug. In July 2009, the FDA added a black box warning to the Chantix label, notifying users abouut the risk of suicidal thoughts and other psychiatric problems that may be linked to the medication.
Following the release of numerous studies in recent years that have contradicted previous information regarding the link between Chantix and suicide, the FDA announced earlier this month that it would be updating the Chantix label to reflect the findings of this research. Based on the findings of the ISMP, however, the FDA has scheduled a joint meeting of two advisory committees for later this month, to review the latest information about Chantix side effects, and to make recommendations on whether the Chantix label should be updated.
The potential risk of psychological side effects associated with Chantix is so severe that the drug is currently banned for pilots and air traffic controllers, and the Departments of Defense and Transportation also limit Chantix use among employees in sensitive occupations. The medication’s side effects have also led thousands of former users across the country to pursue Chantix lawsuits against Pfizer, and the drug maker opted to pay an estimated $300 million in damages, rather than fight the claims in court. If you believe you have been adversely affected by side effects of Chantix, contact a reputable Chantix lawyer today to discuss your options for legal recourse.
[box type=”note” align=”aligncenter” ]Source: http://www.ismp.org/QuarterWatch/pdfs/2013Q3.pdf[/box]