Pilots and air traffic controllers are no longer allowed to
use popular anti-smoking drug Chantix following findings of a study that linked
the drug to mental confusion and other problems that could put passengers at
risk, the Federal Aviation Administration said on Wednesday.
“It’s prudent to deem the drug no longer acceptable for
use,” FAA representative Les Dorr said, as quoted by Reuters.
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.
The new study made by the Institute for Safe
Medication Practices, a non-profit group, and reported to the U.S. Food and
Drug Administration 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 study linked Chantix to a wide array of health and
safety problems including accident and falls, potentially lethal heart rhythm
disturbances, heart attacks, seizures, diabetes and various psychiatric
disturbances.
The findings were based on an analysis of adverse events
reported to the FDA saying that from May 2006 through December 2007, there were
227 reports of suicide attempts or suicide, 397 cases of possible psychosis and
525 reports of hostility or aggression.
The Institute for Safe Medication Practices posted the study
online because its co-author Curt Furberg, a Wake Forest University Medical
epidemiologist thought the findings too important to submit first to a medical
journal, which could take six months or more to publish.
Pfizer defended the drug saying the 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,” said a Pfizer statement, issued by a company
representative, Francisco Gebauer, 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.
Now 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 study is intended to make the FDA to take further steps
in studying the negative effects of the drug, lead researcher of the Institute
for Safe Medication Practices, Thomas J Moore said. “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.”
