Popular Smoking Cessation Drug Gets New FDA Warning
When the safety of U.S. citizens is in jeopardy, FDA officials ride in like fresh cavalry troops to save the day.
Unfortunately they ride sleepy, lumbering hippos.
That’s bureaucrats for you. Especially bureaucrats that really HATE to ever break the bad news that a best selling drug might do considerable harm.
Last month, the FDA announced that the smoking cessation drugs Chantix and Zyban will soon carry new boxed warnings to highlight the risk of “serious neuropsychiatric symptoms.” These symptoms include “changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.”
You won’t believe how long it’s taken the quick-draw artists at the FDA to get around to this warning.
Big numbers
2008 was not a banner year for Chantix.
In October, the Institute for Safe Medication Practices (ISMP) posted this grim milestone: The number of serious drug reactions and deaths reported to the FDA set a new record in the first quarter of 2008 – almost 21,000 serious reactions were reported, and more than 4,800 deaths.
Two factors accounted for these high numbers: 1) Tainted batches of the blood thinner heparin imported from China, and 2) Chantix, Pfizer’s smoking cessation drug.
In previous e-Alerts I’ve told you about the woes linked to Chantix. Just a few of the side effects noted on the Chantix website include nausea, constipation, diarrhea, vomiting, dizziness (and who wouldn’t be dizzy after those first four side effects?), chest pain, depression, and hypertension.
The ISMP notes that not only did Chantix account for 1,001 of the serious reaction reports (the highest number of any prescription drug), but the number of serious reactions was higher in Chantix use than all of the 10 best selling brand name drugs COMBINED.
And it only took the FDA eight short months to get around to requiring a warning.
An Associated Press report included this speculation: “Officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.”
Riiiight – it’s not the drug that’s the problem, it’s the GROWING AWARENESS that the drug is a problem – THAT’S the problem. Got it.
Thin stuff
The October 2008 ISMP announcement also urged the FDA to forcefully warn Chantix users that they might experience blackouts – a pretty serious side effect when you’re driving or flying. That’s why the FAA has already banned pilots from using Chantix.
A Pfizer spokesperson told the AP that clinical trial results show the drug’s benefits “clearly outweigh its risks.” Or – put another way – the drug isn’t as dangerous as tobacco use, which accounts for more than 400,000 U.S. deaths each year.
As faint praise goes, that’s as faint as a puff of smoke.
Sources:
“Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)” FDA MedWatch, 7/1/09, fda.gov“Panel Calls for Vaccine for Adult Smokers” Mike Stobbe, Associated Press, 10/22/08, ap.org
“Reports of Serious Drug Reactions Hit Record” Richard Alsonso-Zaldivar, Associated Press, 10/22/08, ap.org
Jenny Thompson works with the team at Health Sciences Institute to uncover important health information and expose ridiculous health misinformation, most notably through the HSI e-Alert.
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Comments
Anonymous
This is not a black and white issue. There can be many significant adverse effects from chantix but it is very effective for smoking cessation, at least in my practice. Since tobacco use can cause so many health problems, chantix may be an option for people who have tried other options first. If a patient desires to start chantix I have a thorough discusion of all possible side effects and counsel them to stop the medication at the first sign of a significant side effect. I have had one patient with terrible nightmares that resolved quickly after stopping the medication but otherwise have not had patients with significant side effects.
Terri
I was a 54 year old female, smoked 4--5 cigarettes per day. Two hospital stays in 2008 thanks to Chantix.
January '08, middle of the nite, chest pains beYOND excruciating!!!...shooting stomach pains and extreme shortness of breath. Husband dialed 911. Spent a week in hospital. Underwent every test possible from head/toe. Put on oxygen 24/7. Headaches so bad they treated w/morphine. Diagnosis? Perhaps, a virus of some sort...? The doctors did not have a reason/cause.
May, '08. Took a ride to Walgreens after work...decided it was a good nite to die. Now, keep in mind, I have an awesome job (22 years), happily married 35 years, and six, beautiful grandchildren. Everything to live for!! Pulled into a used car parking lot in a rural area, wrote a short goodbye note, and downed over 240 sleeping pills in seconds.
Woke up four days later in ICU in a country hospital. Last rites were given and if, by some miracle I survived, most probably I would need a liver transplant. I was on a ventilator, surrounded by family and friends. It was a nightmare. Miraculously, I survived physically without any obvious permanent damage. Was admitted to a psyche unit, lost all credibility as a mother/wife/grandma. Babysitting rights were taken away indefinitely. Employer wasn't so sure about me anymore...and friends just shook their heads.
It's been 17 months since that awful incident...and 'm just NOW feeling whole mentally. It was a long, hard, road back.
Chantix is in my mind, a "lobotomy by mouth."
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