Hundreds of Chantix Suicides Not Reported by Manufacturer Pfizer

(July 6, 2011) The federal government recently reported that Pfizer, the manufacturer of the stop-smoking drug Chantix, failed to submit years of data and hundreds of reports of suicides, psychotic reactions, and other serious problems to the FDA.

While some have asserted that there could be a link between Chantix and major depression, violent outbursts, and even suicide, Pfizer officials claim that there is no proof that Chantix causes any of these devastating side effects.

Thomas J. Moore, senior scientist at the Institute of Safe Medication Practices – the nation’s only non-profit organization devoted entirely to medication error prevention and safe medication use – said that “[CHANTIX] SEEMS TO UNLEASH SOMETHING IN PEOPLE. IT CAN BE VIOLENCE TO ANYTHING AROUND” [emphasis added]. His studies found that patients with no prior history of violence or mental illnesses were reported to act “inexplicably and unprovoked” when on the drug, or recently off of it. Quite a chilling discovery!

Company officials said that they submitted the required reports immediately upon realizing their error, and claim that they complied when the FDA asked them to change these documents to reflect actual numbers.

If Pfizer had been more forthcoming, the stricter warning that was required by the FDA on July 1, 2009, might have emerged earlier.

Currently, there are over 1,500 Federal court claims brought on behalf of Chantix users who have suffered some injury in addition to many more that are brought in state courts around the country.

The Canadian Medical Association Journal released a new report on our nation’s birthday that adds to the laundry list of problems for Chantix users, as well as its manufacturer, Pfizer. Dr. Furberg, who once directed clinical trials for the government and contributed to this report, stated that “we have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A. It causes loss of consciousness, visual disturbances, suicides, violence, depression, and worsening of diabetes. To this list we now can add serious cardiovascular events.”

Such cardiovascular problems as increased risk of heart attack or stroke for smokers who might not even have a history of heart disease compared with smokers who never used Chantix. Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University, said that “the F.D.A. Should have already put [cardiovascular risks] on their warning label. The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

The study also found that in 28 smokers treated with Chantix, doctors could expect to see one extra cardiac event, and only one in 10 people who took Chantix will quit smoking. I’m not a betting man, but I wouldn’t go to Vegas with either of those odds when it comes to my health, would you!?

The Loophole: FDA Rules on Expected Events:

Whether Pfizer’s failure to report was intentional or merely an oversight is not for this blog to speculate. The bottom line is that last July, the FDA had record of 122 suicides linked to Chantix. After the new Pfizer reports were added, that total skyrocketed to 272!!

Why? Because the FDA does not require pharmaceutical firms to submit any new reports of serious harm in the agency’s system for urgent review when such risks are already known.

In other words, the FDA requires manufacturers to submit reports of any and all adverse effects through an expedited system, where any serious and unexpected side effects are then entered into the system within 15 days. Where the side effect is already known and exists on the warning label, then the FDA ONLY requires the company to send in a report every three months. In Chantix’s case, this means suicide.

FDA officials now are debating whether to change regulations to allow expedited reports of suicides, even if previously indicated on the drug labels. This would ultimately help people who are currently using this drug to be able to assess the real risks.

For more information, check out our website.

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