Tagged Articles

neuropsychiatric symptoms 5 articles

New warnings added to Chantix label include cardiovascular events, psychiatric symptoms

heartbeat

The safety label for the smoking cessation drug Chantix (varenicline) has been updated to include new warnings about cardiovascular risks. The warning is based on a large, combined analysis of clinical trials that showed more serious cardiovascular events occurred in people who were taking Chantix. The report was released late last year by the Food and Drug Administration (FDA), which added that the risks were uncommon in both the Chantix and placebo groups, and that it is difficult to determine whether the excess risk of serious heart events among patients taking Chantix was due to the drug or simply chance. ... Read More

New warnings for off-label smoking addiction drug Aplenzin

The antidepressant Aplenzin (bupropion hydrobromide) extended-release tablets has a new black box warning against the use of the drug to help people quit smoking. The drug is approved by the Food and Drug Administration (FDA) only for the treatment of major depressive disorder, but is sometimes prescribed to treat smoking addiction. This use has been shown to put users at increased risk for neuropsychiatric symptoms and suicide. Aplenzin already has boxed warnings similar to other antidepressants that the drug may increase the risk for suicidal thinking and behavior (known as suicidality) in children, adolescents and young adults being treated for ... Read More

Support group says Chantix ads conceal important information

WhyQuit, an organization that advocates quitting smoking using the cold turkey method, recently published an article that takes Pfizer to task over its latest Chantix ads. The group claims that the pharmaceutical company’s new television commercials hide information from the viewer – information that, if known, would likely dissuade most smokers from using the drug as a smoking cessation aid. WhyQuit reports that in surveys and scientific studies, more people were found to have successfully quit smoking long term using the cold turkey method than nicotine replacement therapies (NRT). NRT delivers smokeless nicotine to the user through chewing gum, lozenges, ... Read More

Family of musician killed in Chantix rage sues Pfizer

The family of musician Carter Albrecht has filed a lawsuit in a Dallas federal court against Chantix manufacturer Pfizer Inc. Ken and Judy Albrecht allege that the drug manufacturer is responsible for the musician’s death in 2007 because it marketed Chantix, which Carter had been taking at the time of his death, while knowing it to be unsafe. Carter, who played keyboard and guitar for Edie Brickell & The New Bohemians, was shot and killed by his girlfriend’s neighbor in the predawn hours of September 3, 2007. According to Ryann Rathbone, Albrecht’s girlfriend at the time, the two had spent ... Read More

FDA approves stronger, expanded warnings on Chantix labeling

The Food and Drug Administration has approved the new labeling for Chantix packaging. In July, we reported that the agency said it would require stronger warnings on all Chantix labeling, as well as packaging for other smoking cessation drugs Wellbutrin and Zyban (bupropion hydrochloride). All of the drugs have been linked to serious behavioral changes and other symptoms. The new boxed warning on Chantix labeling will read: “Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking Chantix.” Revised warnings state that neuropsychiatric symptoms and suicidality have been found ... Read More