The Food and Drug Administration (“FDA”) was established to protect people from unsafe and harmful drugs, but its ability to regulate the drugs that we consume depends on the accuracy of the information that is provided by drug manufactures. If the drug manufactures fail to provide accurate data to the FDA, then the FDA’s safety regulations will be rendered useless. In other words, garbage in is garbage out.
Pfizer, the manufacturer of the popular smoking cessation drug, Chantix has recently come under fire for failing to properly submit data regarding hundreds of episodes of serious psychiatric side effects, including psychosis, depression and attempted suicide according to the Institute for Safe Medicine Practices (“ISMP”). ISMP claimed that Pfizer reported some cases of completed suicides dating back to 2007 as “expected adverse events,” which is how less important, non-serious side effects are reported. According to ISMP, this caused the FDA to be unaware of more than half of the reported suicide cases involving Chantix. A failure to properly report these events is particularly concerning because for the last four years Chantix has been associated with serious adverse effects such as suicidal behavior and vivid dreams. In fact, the government has banned the drug for pilots and refused licenses to truck drivers taking the drug.
Pfizer explains the sudden spike in its reports of suicide to the FDA that occurred after its discussions with the FDA about voluntary implantation of periodic Individual Case Safety Reports in December of 2009 and January of 2010 as the result of changing its submission format. At any rate, the FDA remains concerned about the potential for serious neuropsychiatric events in patients taking Chantix. If you or someone you know has experienced behavioral changes after taking Chantix, you may consider contacting an attorney to discuss the potential for legal claims against Pfizer.
Disclaimer: All use of the Chantix mark are for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope McGlamry is not affiliated with the manufacturer of Chantix, Pfizer, or its distributors