Officials Warn of Risk of Suicide with Two Anti-Smoking Drugs
Attorney
(866) 735-1102 Ext 541
The New York Times reported that federal drug regulators advised patients taking two anti-smoking drugs to watch for signs of mental illness because of an increased risk of suicide among the drugs' users.
However, officials stressed that patients should not stop taking these drugs all together, but just be aware of increased risk of mental illness.
The two drugs are Chantix, by Pfizer, and Zyban, by GlaxoSmithKline. Zyban is also sold under the name, Wellbutrin, which is used to treat people suffering from depression.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
Pfizer is going to add a black-box warning to Chantix packaging and Glaxo is going to expand its already existing black-box warning on Wellbutrin to include Zyban.
Both drug manufacturers are going to conduct clinical trials to determine the extent of the mental health risks associated with these drugs.
Officials for both companies explained that it was difficult to determine whether it was the drugs causing the increased depression and suicidal thoughts, or whether it was the nicotine withdrawal associated with patients trying to stop smoking.
Despite the fear that this latest FDA action would affect drug sales, analysts say that it probably won't have much of an effect because of the previous information related to these drugs and their side effects.
Among those using Chantix, FDA officials have received 98 reports of suicides and 188 reports of attempted suicides. With Zyban, officials discovered 14 reported cases of suicide and 17 reports of attempted suicide.
For more information about the FDA and prescription drugs, click here.
To read the FDA Press Release regarding these two drugs, click here.