(NaturalNews) Pfizer's bestselling anti-smoking drug Chantix has been responsible for more than two dozen traffic accidents, due to side effects such as seizures and loss of consciousness, according to a study conducted by the Institute for Safe Medication Practices.
The institute reviewed the more than 3,000 serious "adverse event reports" submitted to the FDA on the drug, and concluded that current FDA-mandated warnings for the drug are insufficient.
Due to more than 400 reports of suicidal thoughts and more than 30 successful suicides by people who were taking the drug,
the FDA required Pfizer to add warnings to the drug's label about psychiatric
side effects such as anxiety, depression and
suicidal thoughts. Other known psychiatric side effects include strikingly vivid
dreams that have earned the nickname "
Chantix dreams."
But the institute's
review also found reports of dizziness, muscle spasms and even loss of
consciousness.
"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 researchers wrote.
In response to these concerns, the Federal Aviation Administration no longer allows pilots or air
traffic controllers to use the
drug. The military has prohibited its use by flight and missile crews, and is considering expanding that ban.
Pfizer said that it had added warnings about operating heavy machinery to Chantix prescribing literature in May 2007, but apparently the change was never noticed by
doctors or federal transportation officials.
"That is a problem," said
FDA drug evaluation head Janet Woodcock. She admitted that the FDA needs to improve its methods for communicating drug safety information to doctors and other concerned parties.
Chantix helps people quit
smoking by acting directly on the brain to simulate the effects of
nicotine, and also by blocking the effects of real nicotine if the patient should start smoking again while still taking the drug.
Sources for this story include:
www.latimes.com.
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