FDA will review risks of anti-smoking drug
By Matthew Perrone ASSOCIATED PRESS
WASHINGTON — The Food and Drug Administration announced yesterday it will conduct a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer’s anti-smoking drug Chantix.
- The agency said in a federal notice that it will convene its panel of psychiatric-drug experts to discuss the pill’s risks and how to best manage them.
Since 2009, Chantix has carried the government’s strongest safety warning because of links to hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicides and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug.
At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the side effects.
A spokeswoman for Pfizer said yesterday that the company recently submitted new data to the FDA designed to establish the drug’s safety compared with placebo and other anti-smoking therapies.
“Pfizer has proposed an update to the Chantix labeling based on these new data, which, we believe , would better reflect the product’s safety profile as it pertains to neuropsychiatric symptoms,” said Victoria Davis, in a statement.
The New York drug-maker’s FDA submission includes data pooled from multiple Pfizer studies along with studies conducted by the U.S. Department of Defense and the Department of Veterans Affairs. The two federally funded studies, released in 2011, did not show an increased rate of psychiatric hospitalizations among more than 26,000 Chantix patients when compared with patients using nicotine patches and other smoking-cessation treatments. The studies recorded only psychiatric problems that resulted in hospitalization, meaning many issues likely went unreported, according to the authors.
The FDA first began investigating potential side effects with Chantix in 2007, the year after the twice-a-day pill hit the market.
- The drug’s labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug’s risks against its potential benefits in helping patients quit smoking.
No matter how self-serving this may seem, I’m putting it up anyway. Self-serving? What do I mean? Well, that IS “why” I started “smokinchoices” in the first place, isn’t it? I’m in my 7th year now and I’ve had a great time and a fairly good run. Its true that I rarely mention it anymore. . . . it’s 21 years since I quit (and I’m happy to state that I have not broken my promise to self — NOT TO TAKE EVEN ONE PUFF! Even if Margaret were to show up again and offer me another Honey Rose Special, I hope I would say no. Think I finally learned my lesson. )
It was all the infernal ads everywhere hammering people to quit while using their product til I had to put up or shut up; so I dug in and learned how to blog. . .knew it was out there, just never saw one or did it. Anyway, there was never any chance that smoke cessation using this blog was ever going to hurt anyone in any way, in fact. . . the system works well and it’s free and for me, was the plan which helped me ‘get there’.
So whether its smoke cessation, the nutrients we take into our body or the medications we take, its always best to go with the most natural, healthful choices. Not too much logic in opening ourselves up to side effects if there are other options we can use. The pollution of our world is dangerous enough already. Take care, my friends, Jan)