Anti-Smoking Drug Chantix Could Lead To Suicidal Behavior

by Medindia Content Team on November 21, 2007 at 5:24 PM
Anti-Smoking Drug Chantix Could Lead To Suicidal Behavior

Pharma giant Pfizer Inc.'s anti-smoking drug Chantix, is being scrutinized by the U.S. Food and Drug Administration (FDA). There have been reports of the drug bringing on suicidal thoughts and behavior and even in one extreme case, death.

The FDA is currently examining reports of side-effects such as erratic and aggressive behavior and suicidal thoughts and behavior . The drug is known generically as varenicline.


The FDA was quoted :" Many of the cases reflect new-onset of depressed mood, suicidal ideation (thoughts) and changes in emotion and behavior within days to weeks of starting treatment" , in a recent posting about the new review.

As lawmakers and consumer groups step on the pressure for failing to communicate safety problems with drugs regularly , the FDA has started alerting the public earlier about a review, even if it has not come to a conclusion.

According to many drug manufacturers , the agency is taking a tougher stance on safety following the 2004 withdrawal of Merck & Co Inc's arthritis drug, Vioxx and recent safety concerns surrounding GlaxoSmithKline Plc's diabetes drug, Avandia.

"My first thought is this is another example of the FDA being overly safety conscious in light of the withdrawal of certain products, such as Vioxx and Avandia," Damien Conover, an analyst at investment research group Morningstar, was quoted. Yet he agreed that it could still be a problem for Chantix.

"When the (attention deficit disorder) drugs got associated with increased risk of suicidal thinking, you definitely saw a class effect of slower growth," Conover added

Pfizer had reported revenue of $241 million for Chantix in the third quarter of 2007. It has been just recently that the company launched an ad campaign touting the drug.

Meanwhile the FDA has stressed the warning "does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue."

Adverse event reports following a drug's approval are submitted to companies by consumers and doctors. Yet, these are very rough indicators of any potential trends, a Pfizer official was reported.

"Post-marketing reports usually do not allow you to establish a causality because there is very often a significant amount of information missing," said Martina Flammer, a senior medical director at Pfizer

Flammer also observed that programs to cease smoking very often lead to nicotine withdrawal, which could be exacerbated in patients with psychiatric illness.

Yet the FDA noted that not all patients in the cases had a preexisting psychiatric illness and not all had stopped smoking.

In its alert, the FDA has cited one case of a patient whose erratic behavior while on the drug lead to death. However, it did add that alcohol was also involved.

Doctors have been advised to monitor patients taking the drug for changes in behavior and mood.

Source: Medindia
Font : A-A+



Recommended Readings

Latest Drug News

Prolonging Market Exclusivity of Brand-name Insulin
Examining FDA and patent records, researchers found that insulin manufacturers prolong market exclusivity for brand-name products.
FDA Boosts Orphan Drug Designations for Myelofibrosis Treatments
The rise in FDA ODD awards indicates a collective endeavor to create new myelofibrosis medications devoid of mechanisms inducing anemia.
Anti-Rheumatic Drugs May Help Prevent Thyroid Disease
The most significant decrease in autoimmune thyroid disease risk was observed in rheumatoid arthritis patients receiving immunomodulatory drugs or 'biological DMARDs'.
Apotransferrin's Potential in Early Stroke Therapy Revealed
Human apotransferrin injected to mice models suffering from intracerebral hemorrhage was found to mitigate the serious effects of stroke.
Anti-cancer Drug Navitoclax Help Treat Lower Back Pain
The reduction of these senescent osteoclasts, possibly through the utilization of current medications, could present a novel approach in managing lower back pain.
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close

Anti-Smoking Drug Chantix Could Lead To Suicidal Behavior Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests