FDA finally taking another look at rage-inducing Rx

How this drug kills people that don't even take it

It was supposed to help make you healthier.

And maybe it would…if you don’t kill yourself — or others — first.

Now, after eight long years on the market, the FDA is finally getting around to taking another look.

We know it’s not that they’ve been listening to our complaints. But maybe they’re taking their cues from other federal agencies.

The Veterans Administration requires that before someone starts up on this drug, their mental health needs to be “evaluated” first.

And the FAA has banned commercial pilots from using it. Truck drivers are also told not to take it.

So what took so long to get the FDA’s attention? And what might Pfizer have ups its sleeve to keep it on the shelf — no matter how many people end up dead as a result?

It’s hard to imagine someone going on a violent rampage after taking a fish oil supplement for a few days.

Same for someone looking for a sedative effect with melatonin or chasing the blues with St. John’s wort. I don’t think you’ll find any cases where nonviolent people used those supplements and then assaulted someone.

But prescription drugs? Better put your protective headgear on, because with certain types of drugs the side effects can get pretty rough. Especially for innocent bystanders.

And this drug looks like one of the worst.

A few years after Chantix, the popular smoking cessation drug, hit the market, a team led by the Institute for Safe Medication Practices took a close look at adverse-event reports for it.

A quick glance at the Chantix website, and you’ll see what they were looking for. The list of side effects reads like a Stephen King plot outline: hallucinations, suicidal thoughts, panic attacks, depression, and paranoia.

With a dramatic list like that, these other side effects don’t really pop out quite as vividly: anger, and aggressive or violent behavior.

When the ISMP team did some digging, they came up with dozens of wild reports that involved acts or thoughts of aggression or violence.

What’s most disturbing is that almost none of these people had ever displayed extreme moods or behaviors like this before. One subject, who had nightmares, anger, depression, and homicidal thoughts, reported: “It wasn’t me at all during the time I was taking the drug.”

Now, you might wonder if irritability from nicotine withdrawal could spill over into very aggressive behavior. But nearly all the adverse events took place soon after medication started–and BEFORE most of the subjects had actually stopped smoking.

Later, the same ISMP team expanded on their earlier research by combing through the FDA Adverse Event Reporting System. They examined 1,500 reports of homicides, physical assaults, physical abuse, and other acts of violence, along with murderous thoughts. About 80 percent of the reports were linked to antidepressants, sedatives, hypnotics, and ADHD drugs.

And can you guess which of the 31 drugs involved topped the list? Of course! Old, reliable Chantix.

But if Pfizer has anything to do with it, those warnings on the Chantix package and web site might get downplayed by a lot. Or who knows, maybe even go away entirely!

That’s because it’s getting ready to present data that the FDA had requested years ago. Studies to take a look at “the extent” of those side effects.

So did they comb through all those FDA reports for this research?

Well, not exactly. The data going to the FDA, both from Pfizer and two federally funded studies, apparently only looked at psychiatric problems in Chantix users that landed them in the hospital!

That sure leaves out a lot of cases of depression, anger and violence. It only counts, apparently, if you end up in a straitjacket.

And that presentation to the FDA is enough for Pfizer to proudly announce that because of this “new data” it will be proposing an update to the Chantix label.

Wow — I can’t wait to see that “update!”

A spokesperson for Pfizer told a trade pub several years ago that “There is no reliable scientific evidence that Chantix causes violent thoughts or actions.” Apparently, Pfizer’s definitions of “reliable” and “scientific” come out of the “Drug Maker to English” dictionary.

Sources:
“Quit-smoking drug Chantix comes under FDA scrutiny” April 26, 2014, NewsMax Health, newsmaxhealth.com

“FDA should warn smokers of increased danger of Chantix, study says” Carrie Gann, November 3, 2011, ABC News, abcnews.go.com

“Prescription Drugs Associated with Reports of Violence Towards Others” PLoS ONE, Vol. 5, No. 2, 12/15/10, plosone.org

“Chantix, Prescription Drugs and Violent Acts” Ed Silverman, Pharmalot, 12/16/10, pharmalot.com