Chantix: An Anti-Smoking Drug Linked to Serious Injuries
Chantix (varenicline) is a prescription antismoking drug launched by Pfizer in May 2006, after the FDA had granted the drug priority review. Chantix is the only drug designed specifically to combat nicotine addiction ever sold in the United States. In 2007, the drug booked sales of $883 million.
Chantix has been linked to behavior issues resulting in suicide and serious injuries, and to heart problems and a rare skin disease called Stevens-Johnson Syndrome. If you have one of these conditions, please contact Skikos, Crawford, Skikos, Joseph & Millican LLP for a free consultation.
Chantix Linked to Behavioral Issues
Potential dangers associated with the use of Chantix first arose in the press in September 2007. On September 3, 2007, it was reported that Texas musician Carter Albrecht was shot by a neighbor while allegedly using Chantix. Albrecht had been banging and yelling at the neighbor's back door, and was shot accidentally by a warning shot fired by the neighbor. Albrecht's girlfriend stated that shortly after Albrecht started using Chantix, he started having vivid and frightening dreams and hallucinations, often confusing reality with his dreams. Those who were close to Albrecht and knew him well suspected that Chantix contributed to his behavior.
On November 20, 2007, the Food and Drug Administration issued an alert regarding post-marketing reports of suicidal thoughts and aggressive and erratic behavior while using Chantix. In the 4th quarter of 2007 alone, Chantix accounted for 988 serious injuries reported to the FDA, more than any other individual drug on the market at that time. By comparison, the FDA received a median of 5 reports of serious injuries for all other drugs reported on during that quarter.
On February 1, 2008, the FDA updated its alert to highlight warnings that had been added to the Chantix prescribing information regarding serious neuropsychiatric symptoms. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation and attempted and completed suicide.
New Warning Issued for Chantix
On May 16, 2008, the FDA announced that Pfizer had updated its prescribing information further to have patients inform their doctors of any history of psychiatric illness prior to starting Chantix, to alert family members and caregivers of patients taking Chantix to monitor changes in mood and behavior and to have patients immediately report changes in mood and behavior to their doctor.
The Chantix prescribing information now warns that "Serious neuropsychiatric symptoms have occurred in patients being treated with Chantix." The warning also indicates that patients with serious psychiatric illnesses such as schizophrenia, bipolar disorder and major depressive disorder had been screened from earlier clinical trials, and that post-marketing reports indicated that Chantix may worsen these illnesses.
Chantix Linked to Stevens-Johnson Syndrome and Other Injuries
In May 2008, the Institute for Safe Medication Practices issued a report linking Chantix to further side effects, including numerous reports of accidents and injuries, vision disturbances, heart rhythm disturbances, seizures and abnormal muscle spasms severe skin reactions including reports of Stevens-Johnson Syndrome and diabetes.
Stevens-Johnson Syndrome is a rare life-threatening condition that affects the skin, and results in the epidermis separating from the dermis. Although the disease can be caused by infections, it has been linked to the use of several pharmaceutical drugs including Chantix.
Contact Us If You Suffered an Injury While Using Chantix
If you or a family member has developed any symptoms or conditions associated with Chantix, please contact or call us at Skikos, Crawford, Skikos, Joseph & Millican LLP for a free evaluation.
