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FDA Announces Black Box Warnings for Chantix® and Zyban®
The Food and Drug Administration announced on June 30, 2009, that the smoking cessation
drugs Chantix® (Varenicline) and Zyban® (Bupropion) must contain black box warnings
for serious mental health symptoms including hostility, depression, changes in behavior,
and attempted suicide (http://blog.pharmexec.com/2009/07/01/chantix-boxed-warnings/).
In addition to its use as a smoking cessation drug, Bupropion is also marketed as
an atypical antidepressant under the brand name Wellbutrin® and a generic form.
The FDA indicated that these drugs will also receive increased warnings which highlight
their risks for adverse mental health events. These drugs already contain black
box warnings for suicidality.
Analysts were surprised by the FDA’s black box announcement for Zyban® . Bob Rappaport,
Director of CDER’s Division of Anesthesia, Analgesia, and Rheumatology Products,
indicated surprise that Zyban® appeared to offer the same characteristics of adverse
reporting and reporting rates as Chantix® .
Cerilliant offers certified reference materials of Bupropion as well as native and
labeled analogs of its Hydroxy metabolite. We also provide certified solution standards
of a variety of drugs and metabolites associated with smoking and smoking cessation.
Clink on the link below to view these featured certified reference materials:
Cerilliant
Certified Smoking and Smoking Cessation Drug Solutions
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