Researchers at the non-profit Institute for Safe Medication Practices and Wake Forest University, in analyzing post-marketing data submitted to the Food and Drug Administration (FDA) on people who took the drug, found that more than 1,000 health problems and injuries were reported in the first quarter of 2008, including 50 deaths.

The FDA has received hundreds of reports on Pfizer´s smoking-cessation pill, approved in 2006 - Chantix in the U.S. and Champix in Europe - most referring to the behavioral and suicidal thoughts, mood swings and changed attitudes that affect the users.

Last year the reports multiplied. Pfizer released a statement saying the company was aware of the types of reported events the researchers analyzed but that such reports are inconclusive. The company states Chantix is safe and effective when used as directed.

In May, the researchers first reported the rise of serious accidents, vision problems and heart trouble in patients taking the drug, and at that time they cited 173 reports of accidents and injuries. The reports of problems with Chantix/Champix were greater than for any other prescription drug for the second quarter in a row, the researchers added.

In their latest findings, the researchers say there were 1,001 new reported complications and deaths that included 15 traffic accidents and 52 incidents of loss of consciousness.
The FDA has said it is reviewing all the reports.

Chantix/Champix already carries a warning for depression, suicidal behavior and agitation. However, it appears warnings as to side effects are not enough for doctors or patients, as the drug is actually Pfizer´s 11th placed drug in sales for the first nine months of this year, generating $ 666 million dollars. Nevertheless, sales have been decreasing: in the first quarter, sales were $ 277 million dollars; $ 207 million dollars in 2Q2008; and $ 182 million dollars in the third quarter.