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Wednesday, May 21, 2008

Federal Aviation Administration Bans Use of Chantix by Pilots and Air Controllers, Due to Side Effects Risks

Chantix has been linked to serious neuropsychiatric symptoms, which include, but are not limited to, "changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide."
We have all seen the commercials for medications where to get rid of one problem you risk a whole slew of other problems, via side effects. Today we see that the Federal Aviation Administration banned use of Chantix by pilots and air controllers.

In February, the Food and Drug Administration (FDA) issued a warning about a change in warnings and precautions about prescribing the use of Chantix to help smokers quit their habits.

On May 16, 2008, the FDA issued another public health advisory which stated:

At the request of FDA, Pfizer, the manufacturer of Chantix, has updated the Chantix prescribing information to include warnings about the possibility of severe changes in mood and behavior in patients taking Chantix. FDA is highlighting the following related important safety information on Chantix:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix.

Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

(Chantix has been linked to serious neuropsychiatric symptoms, which include, but are not limited to, "changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide.")

Which brings us to todays news that following a new report from the Institute for Safe Medication Practices, the Federal Aviation Administration has banned the use of Chantrix by pilots and air controllers because of the potential side effects involved in using the drug.

The report shows that their are additional risks that stem from using the drug varenicline aka Chantrix. Those risks include loss of consciousness and seizures and we see that over 3,000 incidents have been recorded in the U.S. from the use of Chantix.

According to this report by the Institute for Safe Medication Practices, it asserts that the data studied provides "a strong signal that the risks of varenicline treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers. In addition to the data analyzed for this report are 1608 foreign reports that are consistent with the results reported here. Drug regulatory authorities in Canada and Europe have also issued alerts about possible psychiatric effects."

The report also states that in the 3rd quarter of 2007, Chantix (varenicline) produced more serious reports than any other drug for multiple types of events: more potential cases of angioedema, cardiac arrhythmia, diabetes and severe cutaneous injury.

By the 4th quarter of 2007 varenicline accounted for more reports of serious drug adverse events in the United States than any other drug.

Not surprisingly, a medical director from Pfizer, Dr. Anjan Chatterjee, Pfizer is the manufacturer of Chantix, defends the drug by saying that smoking "is one of the largest problems we face in the world. 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."

I respectfully disagree.

I would rather take my chances with smoking that may or may not lead to lung cancer, than to risk multiple side effects like, changes in behavior, agitation, depressed mood, suicidal ideation, and attempted, completed suicide, unconsciousness, vision problems, heart rhythm disturbances, seizures, skin reactions and hallucinations, and that is just naming some of the problems that have been linked to Chantix.

A FDA spokesperson, 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."

That is good but it leaves me with a glaring question.... shouldn't the FDA have conducted reviews and done some investigating before approving the drug to begin with?