Zyban (bupoprion Hcl)

Serious neuropsychiatric side effects including suicidal thoughts and behavior

Zyban is the trade name for a smoking cessation drug manufactured by GlaxoSmithKline. The generic version, bupropion hydrochloride is manufactured by several different companies.

While there is no definitive evidence on how the drug helps smokers quit, it’s speculated that the drug’s effect on brain chemistry reduces craving and eases the symptoms of nicotine addiction withdrawal.

In 2009, the manufacturers of the smoking cessation drug Zyban and its generic equivalent bupropion were required by the U.S. Food and Drug Administration to add a “black box” warning on the drug, highlighting the “risk of of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.”

Some reports indicated that the risks might intensify as a patient undergoes the possible anxiety and withdrawal sometimes associated with quitting smoking.

In February 2010, the FDA required, in addition to the “black box” warning, that the manufacturer respond to the growing evidence of harmful psychiatric side effects and enact systems and labeling to inform and mitigate the risks, see link below

A similar drug for smoking cessation, Chantix (varenicline) was also directed to include the warning. Chantix is manufactured by Pfizer.

Sheller, P.C. attorneys are investigating cases involving some of these serious neuropsychiatric side effects attributed to Zyban: 

There may be individuals experiencing serious psychosis, mania and other psychiatric states while taking Zyban®, Chantix, or their generic equivalents who do not know that the drugs may be causing or increasing the risks.  In some patients, the psychiatric side effects start almost immediately after the first doses but according to the FDA may continue even after the drug is discontinued. The side effects may appear regardless of a patient’s prior mental health.

The FDA previously recognized the psychiatric risks and suicidal tendencies for bupropion with the brand-named antidepressant Wellbutrin, which contains the same active ingredient as Zyban.

Other side effects not currently being investigated by Sheller, P.C. attorneys include:

As with any medication, do not stop taking the drug without the advice of your medical professional. Some studies and respected medical professionals indicate that the benefits of the drug outweigh the risks of smoking.

The attorneys at Sheller, P.C. are investigating these cases

If you or someone you know has experienced serious side effects from Zyban or Chantix, contact us immediately by filling out the inquiry form or calling 1-800-883-2299.

FDA Letter to GlaxoSmithKline re: new requirements for acknowledging increased suicidality during use of Zyban February 2010

FDA webpage on smoking cessation products January 2010

FDA approved label for Zyban July 2009