The U.S. Food and Drug Administration (FDA) believes the smoking cessation drug buproprion hydrochloride—sold under the brand name Zyban, but also as an antidepressant named Wellbutrin, Voxra, Budeprion, and Aplenzin (formerly Amfebutamone)—might cause suicidal ideations and behaviors, and problems with preëxisting heart complications.
What Is Zyban? When Is It Prescribed?
Zyban is the brand name for the drug buproprion hydrochloride. Made and sold by British pharmaceutical company GlaxoSmithKline, this prescription medication is used to treat nicotine addiction. The same chemical compound can also be used as an antidepressant.
Zyban prevents the brain’s absorbtion of two neurotransmitters: dopamine and norepinephrine. Unlike Selective Serotonin Reuptake Inhibitors (SSRIs), Zyban does not inhibit the reuptake of serotonin. The specific mechanism of action by which Zyban prevents people from smoking is unknown.
Burroughs Wellcome, a British pharmaceuticals company that has since merged with others into GlaxoSmithKline, first developed buproprion back in 1969. The FDA approved the drug as Zyban in 1997, and doctors prescribe it in 150 mg oral release tablets.
Zyban can cause multiple side effects: drowsiness; excitement; dry mouth; dizziness; headache; nausea; vomiting; tremors; weight loss; constipation; and excessive sweating.
As the adverse effects of Zyban have become better known, the FDA has required more stringent product warnings and prescription requirements, culminating to date with a July 2009 “black box” Zyban warning. There is no effort to remove the product from the market, though, and no Zyban recall is in effect.
Zyban Might Cause Suicidal Ideations and Behaviors
The FDA has known for some time that buproprion causes suicidal ideations and behavior when prescribed as an antidepressant. In 2006, the FDA analyzed the results of 372 studies of antidepressants, finding that even young adults (ages 18-25) were also afflicted with behavioral changes. As a result, the FDA ordered antidepressant manufacturers, including GlaxoSmithKline for Wellbutrin, to include added warnings to consumers.
In July 2009, the FDA issued a public health advisory notifying physicians and patients that it required GlaxoSmithKline to place black box warning on Zyban products. Thanks to a review of postmarket surveillance and the adverse event reports it received, the FDA determined that Zyban might cause the following neuropsychiatric side effects:
- Depressed mood
- Suicidal thoughts and behavior
- Attempted suicide
These symptoms appeared in Zyban users regardless of prior diagnosis of psychiatric ailments, but GlaxoSmithKline did not test Zyban on people with serious psychiatric illness such as schizophrenia or bipolar disorder before it sought FDA approval. The FDA acknowledged that many people who quit smoking show symptoms of depression without drug intervention.
Other Zyban Side Effects
Recently, a study conducted at Duke University concluded that those with coronary artery disease faced greater risk of death due to buproprion use. The researchers could not determine the reasons for the connection, but they found the connection statistically significant. For those with heart disease, in an average three years of follow-up, 21.4 percent of the participants still on antidepressants died as opposed to 12.5 percent who were not on antidepressants.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Zyban lawsuit on your behalf if necessary.
If you have taken Zyban and experienced adverse side effects, contact RLG today.