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Chantix, Zyban Get Black Box on Mental Health Issues

Jul 1, 2009 | Parker Waichman LLP

Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including  changes in behavior, depressed mood, hostility, and suicidal thoughts.  A Black Box Warning is the Food & Drug Administration's (FDA) most serious safety notice.

It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side  effects in late 2007.  In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning.

The FDA said today that  new Black Box Warning for Chantix and Zyban was based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.  According to a report in The Washington Post, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.

In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.  The agency also said that some of the problems could have been the result of nicotine withdrawal, however many of the reported events occurred while patients were still smoking.

Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin.  In 1997, the FDA approved Zyban to be used as a quit smoking aid.   In today's announcement, the FDA said  similar information on mental health events will be required for Wellbutrin and its generic equivalents. These drugs already carry a Black Box Warning for suicidal behavior in treating psychiatric disorders.

The FDA said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.

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