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FDA Wrong to Remove Chantix’s Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety

Smoking Cessation Medication Can Cause Psychiatric and Neurologic Side Effects

WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA) removal of the black box warning on the smoking cessation medication Chantix (varenicline) sets a dangerous precedent for the future of medication safety in this country, Public Citizen said today.

Despite years of evidence and thousands of reports of depression, suicide, agitation, hostility and other severe side effects with Chantix, the FDA relied on a single, poorly designed clinical study to remove a black box warning, a move the agency has, to our knowledge, never before taken. The FDA scientists tasked with reviewing the study identified no fewer than six major flaws, with the result that, in their opinion, the precise number and scope of adverse events were “not accurately captured by the study.”

“A single study, incapable of ruling out severe side effects, should not be used as the sole basis to eliminate a prominent warning about Chantix’s potential to endanger patients and others,” said Dr. Sammy Almashat, MPH, a researcher with Public Citizen’s Health Research Group. “This seemingly unprecedented move has opened the door for other companies to do away with black box warnings on their products by conducting similarly flawed studies.”

Public Citizen, the Institute for Safe Medication Practices (ISMP), the National Center for Health Research, Consumers Union and the National Physicians Alliance petitioned the FDA in 2014 for a stronger and simplified black box warning on Chantix, a request that was denied by the FDA on Friday when the agency decided to remove the warning altogether. The FDA took this action despite acknowledging that the risks for severe neurologic and psychiatric side effects exist.

“With this action, the FDA has made it less likely that doctors and patients will be aware of Chantix’s dangers,” added Thomas J. Moore, senior scientist with the ISMP and a leading expert on Chantix side effects. “Despite the FDA’s error in judgment, patients and physicians need to know that Chantix can cause violent and suicidal behavior, paranoia and psychosis – often beginning soon after starting the treatment, and in people with no previous history of any psychiatric disorder.”