 |
|
|
Following the negative publicity surrounding Chantix lately,
the U.S. Food and Drug Administration decided to run another safety review of
the drug.
This would be a second time when the federal agency makes
such an investigation after the first, undergone in February, revealed an association
between Chantix and serious neuropsychiatric symptoms. At the time, the FDA
requested that Pfizer elevate the prominence of this safety information to the
warnings and precautions section of Chantix prescribing information or
labeling.
As if this wasn’t enough, last week, a report by the
Institute for Safe Medication Practices, a non-profit watchdog group warned 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 224 cases of potential heart-rhythm
disturbances, 372 reports of possible movement disorders and 544 reports of
likely glycemic problems, including diabetes. Also, there were 173 serious
injuries, some resulting from traffic accidents where drivers on Chatix
treatment were dizzy, mentally confused or became unconscious.
These
findings prompted the Federal Aviation Administration and the Federal Motor
Carrier Safety Administration to ban Chantix’ use by their pilots, air
controllers and truckers.
Also,
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research
said the agency is reviewing all the reported cases, but this will take time,
Reuters reports. Until then, patients using Chantix are urged to stop taking it
and to immediately call their health care providers if they experience
agitation, depression, behavior changes or suicidal thoughts.
Meanwhile,
Pfizer decided to launch a nationwide campaign consisting in ads in the country’s
five largest newspapers to save Chantix.
The
company also plans to send letters to 300,000 health-care providers and to
organize conferences with reporters. Moreover, television commercials are
scheduled to run in June emphasizing the importance of smoking cessation, without
recommending or mentioning Chantix.
© 2007 - 2008 - eFluxMedia