Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
CHANTIX® SMOKING CESSATION DRUG
June, 2009. The U.S. Food and Drug Administration (FDA) is investigating a potential safety concern and label change for smoking cessation drug Chantix® after reports of seizures or blackouts. A safety watchdog group known as the Institute for Safe Medication Practices (ISMP) reported data that found over 1,000 reports of seizures among Chantix® users in the first quarter of 2008. Fifteen of the reports allegedly caused traffic accidents after black-outs while driving. The Federal Aviation Administration banned pilots and air traffic controllers from using Chantix® in 2008. In addition to the FDA investigation regarding seizures, nearly 400 reports of suicidal thoughts/tendencies/actions have been reported among patients with almost 40 suicides among patients allegedly caused by the smoking cessation drug. Chantix® is marketed by the pharmaceutical company, Pfizer.
JULY 1, 2009. UPDATE: FDA ANNOUNCES ADDITIONAL WARNING TO BE ADDED TO LABELS OF CHANTIX® AND ZYBAN® AFTER REPORTS OF DEPRESSION AND SUICIDAL THOUGHTS WHEN USING THE DRUGS
Two popular anti-smoking drugs will now carry warnings about the risk of severe mental health problems, the Food and Drug Administration announced. The FDA said Chantix® and Zyban® will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs. The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor. The agency also is requiring Pfizer Inc., which makes Chantix®, and GlaxoSmithKline, maker of Zyban®, to conduct a study looking at how often these serious symptoms occur. The FDA says that since Chantix® was approved in 2006, the agency has had reports of 98 suicides and 188 attempted suicides. Zyban® has had reports of 14 suicides and 17 attempts. Zyban® contains the same active ingredient as the antidepressant Wellbutrin® and already carried a box warning about the increased risk of suicidal thinking and behavior. Neither Chantix® nor Zyban® contains nicotine, and the FDA said some symptoms could be the result of nicotine withdrawal. Still, the agency said, people using these drugs experienced some of these symptoms while they were still smoking. Pfizer says it updated its label in 2007 to include information of neuropsychiatric symptoms and has revised the label again to reflect the new warning.
If Chantix® harmed you or a member of your family, you may be eligible for financial compensation. Please fill out our online form or call our Chantix® lawyers at 1-850-444-9500 or toll free at 1-888-839-3775 to discuss your legal rights.
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Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
