BernieHund: The Political Watchdog

It seems that the FAA is acting quickly on this one.  In a report that was delivered to the FDA today, a medical safety group warned that Chantix, the anti-smoking drug contributed to automobile accidents and posed other risks.  The FAA immediately acted to ban its use from those who pilot our commercial aircraft and those who direct air traffic.

The drug, called Chantix, had been hailed as an innovative treatment to help smokers quit. But a report from a medical safety group — also issued today –linked the medication to a variety of unusual and serious side effects, including loss of consciousness and seizures, and prompted the FAA to act, said spokesman Les Dorr.

The agency had approved the drug last summer, before drug safety regulators began investigating reports of serious psychiatric problems, including suicidal behavior, sharp shifts in mood and vivid nighttime episodes some patients call “Chantix dreams.”

The warning was contained in a report by the Institute for Safe Medication Practices based on an analysis of “adverse events” reports submitted to the Food and Drug Administration.

Now it will be curious to see how quickly the FDA reacts, if it does at all.  We know that over the past year or so the FDA has allowed many drugs to stay on the market, allowing the manufacturers to earn as much as possible before removing the drug from the market.  Chantix is a Pfizer product.

The study reported:

“We have immediate safety concerns about the use of [Chantix] among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,” the study said.

The study went on to say

The study also cited a range of other serious reported side-effects, including vision problems, heart rhythm disturbances, seizures and skin reactions. The nonprofit group that conducted the study advises hospitals and doctors on the prevention of medication errors, and is based near Philadelphia.

“These data provide a strong signal that the risks of [Chantix] treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers,” the report said.

The FDA responded, as expected.

Responding to the study, FDA spokeswoman Susan Cruzan said: “We agree that these findings are a signal that requires further investigation and confirmation, and the FDA has been conducting a review of the adverse events associated with Chantix.”

The agency has recently issued warnings about the mental health effects of the drug, as well as the possibility that taking it could impair driving.

And, of course, Pfizer defended Chantix.  But, what would one expect?

Manufacturer Pfizer strongly defended Chantix. Smoking “is one of the largest problems we face in the world,” said Dr. Anjan Chatterjee, a Pfizer medical director. “When you think about it in that perspective, the risk-benefit analysis is still substantially toward benefit. Even medications most people consider innocuous have side effects.”

We can expect the FDA to move slowly on this one as we can expect Pfizer to fight a ban on Chantix.  It is a money maker.

A month’s supply of the drug costs $130, and treatment can last from three to six months. More than 3.5 million people in the United States have used the drug.

As with Heparin, Vioxx, and Ortho-Evra, we can expect little movement within the FDA until more deaths occur.  After all, if there is one thing we should have learned by now, it is that the FDA protects corporate interests before personal interests.