FDA Mandates New Warnings For Prescription Smoking Cessation Drugs
On July 1, 2009, the Food and Drug Administration (“FDA”) issued an alert that requires manufacturers of several popular prescription smoking cessation drugs to add additional warnings to their products highlighting the risk of serious neuropsychiatric symptoms in persons using the drugs. The FDA also issued a Public Health Advisory to the public that these drugs have been associated with reports of changes in behavior such as hostility, agitation, depression and suicidal thoughts and actions, and that people who have had any of these serious symptoms should stop taking the medication and call their health care professional right away.
The drugs varenicline (which is marketed under the name Chantix) and bupropion (which is marketed under the name Zyban and is also marketed generically) are prescription drugs that have been prescribed to millions of people who wish to stop smoking. According to the FDA, some people who have taken these drugs have experienced serious and dangerous psychiatric side-effects, which include agitation, depression, hallucinations, mania, nightmares and psychosis. The most serious side-effect has been people having suicidal thoughts, and attempting to or actually committing suicide. Some people have reported having automobile and other accidents while taking the drugs, and other people have reported violent episodes associated with the drugs.
The reports of the psychiatric side-effects have mostly been in the “postmarket” period, meaning that the FDA has learned about the side-effects after the drugs were approved for use in the United States. The “postmarket” experiences with Chantix and Zyban led the FDA to issue new requirements that these drugs have “Boxed Warnings” to alert consumers about the serious psychiatric side-effects that have been documented, and also led the FDA to warn the public about the side-effects.
Stopping smoking is a positive thing, but consumers should be cautious about the medications that they use to help quit smoking. If you or someone you know has experienced serious psychiatric side-effects that you believe are associated with Chantix or Zyban, please contact us to discuss your legal options.
