As anti-smoking laws sweep across the globe, more and more people are really trying to quit. There are many aids in helping to quit smoking cigarettes, from nicotine patches to smoking cessation drugs. Recently, the US Food and Drug Administration (US FDA) issued a safety alert on two of these drugs, namely:
- Chantix (varenicline), manufactured by Pfizer
- Zyban (bupropion), manufactured by GlaxoSmithKline (GSK).
The regulatory body warned that these two drugs increase the risk for mental disorder and suicide. The manufacturers of the said drugs have been asked to add a so-called black box warning to their labelling, explicitly warning against mental health events and suicide risks. A black box warning is displayed prominently on the packaging and is the highest level of safety warning on a drug.
It is not clear whether the psychiatric side effects are due to the drugs themselves or due to nicotine withdrawal which is characterized by depressive symptoms. However, some smoking cessation drugs are chemically similar to anti-depressants. Zyban, for example, is also marketed by GSK under the name of Wellbutrin for the indication of depression.
Aside from the black box warning, the two drug manufacturers are also asked to conduct clinical trials that will assess the psychiatric health of the two drugs, including how they could exacerbate already existing disorders such as schizophrenia, polar disorder, and clinical depression.
Smoking cessation drugs gained bad publicity in 2007 in Europe. As The New York Times report
In September of that year, Jeffrey Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and New Bohemians, was killed by a neighbor who had complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht’s girlfriend blamed Chantix, which she said had made him hostile.
Scrutiny by health officials showed the following figures:
- 98 cases of suicides and 188 cases of suicide attempts among Chantix users
- 14 cases of suicides and 17 cases of suicide attempts among Zyban users.
The US FDA safety warning gives the following guidelines:
Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.
However, the regulatory emphasized that the smoking cessation drugs offer some health benefits, too. According to Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking. Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”
Photo credit: stock.xchng