FDA Makes It Official: It's Investigating Chantix and Its Side Effects
On September 4, we posted to Unfair Park an item about the smoking cessation drug Chantix, which Carter Albrecht's girlfriend, parents and bandmates blamed on his erratic, violent behavior the night he was killed. Every other day since then, someone has posted a comment to that item. Only last week a woman named "Laurie" claimed the drug caused a dramatic alteration in her husband's mood and behavior: "Tonight," she wrote, "he had a violent yelling accusing episode ... He has changed and I have known this man for over 20 years." And now, as predicted, the government is taking a good, hard look at the drug and its manufacturer, Pfizer. Yesterday, the Food and Drug Administration released an Early Communication about an Ongoing Safety Review of Chantix, in which it says:
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
A longer FDA release concerning Chantix can be found here. And according to this report from late Tuesday, Pfizer has updated Chantix's product label to include "reports of depressed mood, agitation, changes in behavior, suicidal ideation, and suicide in patients attempting to quit smoking while taking Chantix."
As you may recall, Pfizer refused to test for traces of Chantix in Albrecht's blood -- after the Dallas County Medical Examiners Office said it didn't even have a way to look for the drug during the autopsy. --Robert Wilonsky