Drugmaker sent data to FDA through 'improper channels' Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug's manufacturer, submitted years of data through "improper channels."
Some 150 suicides - more than doubling those previously known - were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.
"We've had a major breakdown in safety surveillance," said Thomas J. Moore, the ISMP senior scientist who
analyzed the data. The serious problems - including reports of completed suicides, suicide attempts, aggression and hostility and depression - had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved.
They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts.
"It's really chilling," said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the
Journal of Pharmacotherapy. "This seems to unleash something in people. It can be violence to anything around."
Comment: In the US there have been numerous studies showing the serious health effects of Aspartame. For more information about how the FDA suppressed these studies, read the following articles:
The Deadly Neurotoxin Nearly EVERYONE Uses Daily (VIDEO)
America's Deadliest Sweetener Betrays Millions, Then Hoodwinks You With Name Change
Aspartame: The Politics of Food
A Dangerous Spin On The Cancer Risks Of Sugar-Free Sweeteners
Searle, Monsanto and Ajinomoto: Three Corporate Miscreants in the Toxic Junk Food Additive and Aspartame Business
ASPARTAME - The Silent Killer
FDA Hid Research That Damned Aspartame: Fatal Studies Should Have Blocked NutraSweet Approval