Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review.The reports were missing because the drug’s manufacturer Pfizer Inc. submitted years of data through 'improper channels', according to the Food and Drug Administration.
Serious problems — such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others — were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006, the year Chantix, or varenicline, was approved.
Cases of 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues uncovered in new analysis by the Institute for Safe Medication Practices (ISMP).
Thomas J Moore, the senior scientist who analysed the data for the non-profit ISMP, said: 'It’s really chilling. This seems to unleash something in people. It can be violence to anything around. We’ve had a major breakdown in safety surveillance.'
His analysis echoes previous horror stories that Chantix can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and violent outbursts. Read More
