Following the Federal Aviation Administration’s decision to
ban use of anti-smoking drug Chantix by pilots and air controllers on
Wednesday, now it is the Federal Motor Carrier Safety Administration’s turn to
warn against the medicine.
On Thursday, the agency urged medical examiners “to not
qualify anyone currently using this medication for commercial motor vehicle
licenses,” the Wall Street Journal reports.
The dramatic decisions follow a report by the Institute for
Safe Medication Practices, a non-profit watchdog group based in Horsham, Pa.,
which warns against “use of Chantix among persons operating aircrafts, trains,
buses and other vehicles, or in other settings where a lapse in alertness or
motor control could lead to massive, serious injury.”
The report linked Chantix to 988 serious events in the last
quarter of 2007 alone.
The
drug, made by Pfizer, was approved in 2006 for sale in the U.S. and the European Union. Sales
of the drug were $883 million last year and an estimated 6.5 million people
have used it worldwide.
Since
approval, Chantix has been under fire due to its serious side effects such as
depression, suicidal thoughts, aggression, or possible psychosis. Now, the new
report also found the drug responsible for potentially lethal heart rhythm
disturbances, heart attack, seizures and diabetes in its users. Of special
concern for those operating airplanes and trucks, there were 173 serious
injuries, some resulting from traffic accidents where drivers were dizzy,
mentally confused or became unconscious.
“We
would not have written this report if all we had seen were the psychiatric
effects, because the FDA has already issued a public health advisory on that.
The nonpsychiatric elements are the ones that concern us,” lead researcher of
the Institute for Safe Medication Practices, Thomas J Moore said.
Following
the release of the report, Pfizer issued a statement defending the drug saying
its label already contains safety warnings about driving or operating machinery.
“There are few things that provide greater health benefits than quitting
smoking. When considering the use of Chantix for their patients, health care
providers should discuss the risks of smoking, the health benefits of quitting
smoking, and the product’s efficacy and safety profile,” Francisco Gebauer, a
Pfizer representative wrote in the statement, the New York Times reported.
Pfizer
added new warnings to the drug’s label no further than February
this year, when the FDA warned about the risk of mood and behavior changes. The
warning also said Chantix could impair patient’s ability to drive or use heavy
equipment.
The
FDA representative Susan Cruzan said the agency was still investigating the
drug’s psychiatric effects. “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.” However, an
investigation into the nonpsychiatric effects of Chatix has not been initiated
yet, Cruzan said.
On
Friday, patients using Chantix were warned to stop taking it and to immediately
call their health care providers if they experience agitation, depression,
behavior changes or suicidal thoughts.
The
findings of the study were posted online because its co-author Curt Furberg, a
Wake Forest University Medical epidemiologist, thought the findings too
important to submit to a medical journal, which could take six months or more
to publish.