Just when Pfizer thought things couldn’t get any worse for its stop-smoking drug Chantix, it heard from the FDA…again.

This time the agency told the drugmaker it needs to add another warning to the box. One saying that it can lower your ability to drink alcohol safely and that it’s also linked to seizures.

Ironically, it got that information in part from studies Pfizer submitted itself.

How the mighty have (almost) fallen…

Just last October, the company asked for an expedited meeting with the agency. One to remove a warning saying that Chantix can cause “serious neuropsychiatric events.” Events such as “hostility, depressed mood,” and suicidal behavior.”

It wanted all those side effects stripped from the drug’s packaging. Apparently, it considered its clout with the FDA big enough to get its way.

But in a surprise move, the FDA said “No.”

And to double the surprise, the FDA has just ordered the company to add those extra warnings.

But a company like Pfizer isn’t one to take a blow like that and not come back swinging.

So it funded a study, one just published in JAMA, showing that Chantix works not just for those who have decided to quit smoking, but for those who are just thinking about quitting sometime in the future.

Perhaps the most brilliant part of this company-sponsored “research” is the potential 14 million more people that could be snared into taking the drug.

Pfizer is also currently hard at work conducting a clinical “safety” trial to present to the FDA later this year. One it hopes will finally get those frightening warnings off its product once and for all.

Too bad there isn’t a drug that would make Pfizer quit.

Source:

“Chantix may lower alcohol tolerance, up seizure risk: FDA” Caroline Cassels, March 9, 2015, Medscape, medscape.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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