Popular smoking cessation drug gets new FDA warning

Slow on the Draw

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