This one will go down in history as one of the most dangerous drugs ever

Adverse event roulette

They almost sound like movie trailers…

On a cross-country flight, a man charges the cockpit, forcing an emergency landing in North Dakota.

A Pennsylvania man and his wife take their own lives in a murder-suicide.

A Vermont woman is gunned down by her son.

Tragically, they are anything but fiction. These incidents, and many more, have one thing in common. In each case, violence was committed by someone using one of the most horrible drugs I’ve ever told you about: Chantix, Pfizer’s smoking cessation drug.

Commenting on the Vermont case, a Pfizer spokesperson said: “There is no reliable scientific evidence that Chantix causes this kind of behavior.”

For a minute, we’ll ignore the disgust I feel when I read that. Actually, I won’t. It’s like Pfizer is being run by robots instead of human beings. People are dying and being killed, possibly because they are using your product. Pretend for one second you care about anything other than your share price and your legal fees.

OK…back on topic. There may not be any “reliable scientific evidence,” but we are seeing a massive mountain of evidence from individual cases.

Last month, all that evidence was put in a spotlight that both Pfizer and the FDA would probably like to shine on something else.

Spinning the barrel

Chantix comes with a black box warning AND a mandatory Medication Guide. But in spite of those warnings, and in spite of declining use, Chantix was still “suspect in more possible cases of hostility-aggression, depression and psychosis than any other monitored drug.”

That review came from researchers at the Institute for Safe Medicine Practices (ISMP) after analyzing FDA MedWatch reports for the second quarter of 2010.

But if those researchers were expecting to find more of the same when they reviewed the third quarter reports, they were in for a shock.

Pharmalot reports that the ISMP team found 150 cases of completed suicides. The FDA requires suicides linked to a drug’s use to be reported within 15 days, but some of the suicides in the report were several years old — dating as far back as 2007.

So at first, it looked like Pfizer had classified the suicides as “expected adverse events” and catalogued them among 26,000 similar events.

When the ISMP exposed this move, the FDA issued a clarifying statement, explaining that the agency had simply asked Pfizer to resubmit previous adverse event reports that had actually been reported at the proper time.

FDA: “These reports confirm what we already knew about Chantix.” And: “FDA does not have any new safety concerns with Chantix.” (No new safety concerns?! That’s fine…but aren’t the old ones scary enough?)

What appeared at first to be a sneaky way to hide all those suicides turned out, at least according to the FDA, to be a misunderstanding.

But look what happened. Pfizer revealed just how completely devastating this drug really is — 150 reported suicides among the 26,000 adverse events on record! And the FDA revealed just how tolerant and patient the agency can be when dealing with the world’s largest drug company.

In a rational world, the revelations from this snafu would be an overwhelming wake up call. Sudden violent rages, murders, suicides — these aren’t drug side effects, they’re events that destroy lives and traumatize family members for a generation.

And yet: “FDA does not have any new safety concerns with Chantix.”

Well…maybe one concern…

Last week, the FDA issued a warning that Chantix “may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.”

If you’re a smoker with CVD, you just got lucky because now your doctor is far less likely to recommend this incredibly dangerous drug. You’ll find another way to quit smoking (check this link for three tips), and you’ll never have to play an insane game of Chantix adverse event roulette.

If you know someone who’s trying to quit smoking, Please warn them about the possible dangers of Chantix. And if you don’t want to nag them, pass along this email and I’ll be happy to do it for you.

Sources:
“Signals for Varenicline, Levofloxacin and Fentanyl” Institute for Safe Medicine Practices, 1/27/11, ismp.org
“Pfizer Did Not Report Chantix Side Effects Correctly?” Ed Silverman, Pharmalot, 5/18/11, pharmalot.com
“Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events” FDA MedWatch, 6/16/11, fda.gov