Litigation

Chantix: Reports of More Serious Side Effects

The Wall Street Journal Health blog reports that more than 100 traffic or personal injury incidents have been linked to the smoking cessation drug Chantix, according to the Institute for Safe Medication Practices. Researchers theorize that visual disturbances that may be caused by Chantix are causing these accidents. Patients on Chantix are reporting convulsions, seizures, blackouts, or spasms that could be the cause of injuries with Chantix users.

The report said that 86 cases of convulsions Chantix have been reported since 2006. These numbers are vastly underreported according to Thomas Moore, one the researchers at the Institute for Safe Medication Practices. Moore told The Wall Street Journal he and his fellow researchers were very conservative in the estimates they made in this study.

Pfizer says that there were only three seizures reported with Chantix in the pre-market studies that were conducted before Chantix went on the market. The problem is that Pfizer pressed the FDA to rush Chantix onto the market. When you add "rushing to the market" and "drugs that alter brain chemistry" together, is there any great surprise when the sum equals problems?

Consider this: approximately 4,500 people took Chantix during the development of the drug, with about 450 people getting treatment for at least six months and another 100 for a year. Most of the pre-market study groups were given Chantix for 12 weeks or less. Since then, more than 6 million people have been prescribed Chantix, many of which are long term users.

Again, can we be surprised to learn that we have not flushed out all of the potential problems with Chantix? Lawyers handling Chantix cases were already investigating the suicide risks that have been reported to be associated with Chantix. Now, lawyers are looking at a potential class action involving these Chantix injuries that appear to be caused by these visual disturbances as well as other side effects being discovered such as potentially lethal cardiac rhythm disruptions, acute myocardial infarction, seizures, diabetes, and psychosis. Chantix has also been previously linked in a small number of cases to Stevens Johnson Syndrome, a potentially deadly skin disease.

The FDA has egg on its face again with Chantix. Yet, the Supreme Court is telling us that the FDA should be the sole watchdog for medical devices and perhaps even all pharmaceutical drugs and it will be if the industry has its way in Wyeth v. Levine this Fall. Coming on the heels of debacles with Medtronic leads and Heparin, both cases where the vigilant FDA could have made a difference, you can expect victims' advocates in Congress will have a lot of ammunition to take this ball away from the Supreme Court on the question of preemption.

Full post as published by Trial Lawyer Resource Center on June 06, 2008 (boomark / email).