FDA does away with black-box warning on stop-smoking med Chantix

Chantix loses black-box warning, but still as risky as ever

I hope you had a very merry Christmas!

And if quitting a smoking habit tops your list of New Year’s resolutions, there’s something important you need to know.

The Pfizer stop-smoking med Chantix hasn’t gotten any safer.

Nevertheless, the FDA waved its magic wand and that big, scary black-box warning — the one about the risk of suicidal thoughts, hostility and depression — went poof!

And along with it went the opportunity for many doctors and their patients to realize that trying to stop smoking with Chantix can turn into one of the most frightening ordeals imaginable.

If at first you don’t succeed…

The FDA just signed off on the deal of the century for Pfizer.

For the last seven years, the drugmaker has had to endure the terrible financial hardship caused by a statement on Chantix that starts out by warning of “SERIOUS NEUROPSYCHIATRIC EVENTS.” And that’s right on the first page of the label, no less.

But don’t start a fundraiser for them just yet! Despite that handicap, the pharma giant still managed to bring in over $670 million on the drug last year.

And while it has been busy the past few years trying to get rid of that black box warning, Pfizer has also been hard at work on confidentially settling Chantix lawsuits to the tune of hundreds of millions of dollars and involving thousands of patients — ones like Billy Bedsole Jr.

When Billy was prescribed Chantix in 2007, what was supposed to be an improvement in his health turned into an “incredible ordeal” that included memory loss, depression, and thoughts of suicide. He ultimately landed in the hospital.

Another patient’s experience with Chantix put her in a psychiatric ward. And to get her there, it took five EMT’s and several firemen! She became paranoid, aggressive, and totally confused and started having hallucinations.

So you would think that black-box warning would have stuck on Chantix like superglue.

Yeah, you would think.

But apparently when you’re Pfizer, it seems all you have to do is keep trying, and the FDA will eventually grant your wish. And that’s true even if the evidence you’re using is filled with flaws and big payments to the doctors who conducted the studies it’s based on.

The group Public Citizen, which has been fighting not only for Chantix to keep that black box, but for the FDA to make it even stronger, calls this a “dangerous precedent” for the future of drug safety in the U.S.

The group also warned that doctors and patients need to be aware that Chantix can cause “violent and suicidal behavior, paranoia and psychosis,” whether those warnings are on the label or not.

Certainly anyone who decides to stop smoking once and for all deserves a truckload of support and credit – not the risk of being subdued and taken to a mental hospital!

The good news is that there are some natural ways to try and kick the habit that don’t involve taking dangerous drugs.

For example:

Watch what you eat. Some foods and drinks are much more likely to make you want to smoke. In a study done at Duke University, smokers reported that red meat, coffee and alcoholic beverages made their cravings stronger. On the other hand, milk, fruits and veggies had the opposite effect.
Try GABA. Gamma-Aminobutyric acid (GABA) is often used for controlling anxiety. But a study out of Yale found that taking a GABA supplement may actually make smoking less pleasurable.
Don’t be a camel! Make sure you keep drinking enough water to help flush the nicotine out of your body. Especially when you first quit, not skimping on water will help you to beat some of the cravings.

So, here’s to a smoke-free and Chantix-free 2017!

“Black box warnings removed from Chantix, Zyban” HealthDay, December 19, 2016, webmd.com