Chantix Maker Missing Reports in Drug Safety Review
It has been a well-known fact for the last few years that the smoking cessation drug Chantix has serious side effects that could lead to suicide and violence.Now, a reason warnings were not made sooner may be coming to light.
According to MSNBC.com, the Institution for Safe Medication Practices (ISMP) has found where hundreds of reports of suicides and other violent reactions to the drug were left out of the government’s safety review because the drug’s manufacturer, Pfizer, Inc., submitted its data through “improper channels.”
About 150 suicides were included in the 589 missing reports that the new analysis has found. Officials with the Food and Drug Administration (FDA) admitted that after recognizing some of the reporting was coming through in an inappropriate format, it asked Pfizer to resubmit the data. The FDA has not changed its position on the drug, merely requiring that a black box warning regarding the risk of suicide be placed on the box.
“If Pfizer had been more forthcoming, the black box warning might have emerged earlier,” says the father of a man who killed himself and his wife while taking the drug. “For all we know, the drug would not have been available.”
At least 1,545 injury claims that cite Chantix are currently being argued in federal court. If Chantix has adversely affected you or someone you know, contact a Colorado personal injury lawyer with McDivitt Law Firm to assist you.Back to the Blog