Daniel Williams hoped Chantix would help him quit smoking and become healthier. Instead, he believes, it nearly killed him.
By Ricardo Alonso-Zaldivar
Los Angeles Times
May 25, 2008
WASHINGTON — Daniel Williams decided he'd listen to his girlfriend and his
8-year-old son and finally quit smoking, with the help of a new prescription
drug called Chantix.
He started taking the medication, and a couple of nights later, as he was
driving his pickup truck on a country road in Louisiana, Williams suddenly
swerved left.
His girlfriend, Melinda Lofton, who was with him, later told him that his eyes
had rolled back in his head and that it had seemed as if he was frozen at the
wheel, accelerating.
Moments later, they were in a bayou, struggling to escape the murky water,
Williams said.
"Since I was a kid, never had anything like this ever happened before," he
said.
"It never happened before, and it hasn't happened since. And all the tests
I've taken say I have nothing wrong with me at all."
The nonprofit Institute for Safe Medication Practices last week linked Chantix
to more than two dozen highway accidents reported to the Food and Drug
Administration, saying the mishaps may have resulted from such drug side
effects as seizures.
The FDA had earlier issued a warning about suicidal thoughts and suicides
among patients taking Chantix and is now evaluating whether it needs to expand
and strengthen that precaution.
Pfizer, the drug's manufacturer, said that as early as May of last year, it
had added a warning to the prescribing literature for Chantix that patients
should exercise caution when driving or operating machinery until they know
how the medication affects them.
But such admonitions apparently didn't get much notice from busy doctors. Even
some government transportation agencies missed them.
The Federal Aviation Administration continued, until last week, to list the
drug as approved for pilots. The federal truck safety agency was also unaware
of the risk.
"That is a problem," said Janet Woodcock, head of the FDA's drug evaluation
center, adding that her office needs to find ways to communicate safety
information more effectively.
The military, which bans Chantix for flight and missile crews, is considering
whether other precautions are needed, Pentagon officials said.
Woodcock said the FDA believes the medication should remain on the market as
an option for smokers trying to quit.
Approved two years ago, it differs from other smoking-cessation drugs by
acting directly at sites in the brain affected by nicotine, blocking the
pleasure that comes from smoking as well as the cravings.
But Williams, 28, said he was surprised that a drug he had hoped would help
turn him into a healthier person instead, he believes, caused an accident in
which he could have been seriously hurt, even killed.
Lofton is still struggling with a neck injury she suffered.
Williams, a telephone service technician, lives near Rayville, La., between
Shreveport and the Mississippi River.
He said he went to see his doctor last year for help quitting his nearly
two-pack-a-day habit. He'd started smoking in high school and had failed in
previous attempts to quit.
But he knew people who recommended Chantix.
"They were talking about how good it was supposed to be, and it seemed like
the right thing to do since I was trying to quit," Williams said.
The crash occurred July 15, two days after he started taking Chantix.
He said the last thing he remembers is heading home after checking on the
house of a friend who was out of town.
"I woke up in the bayou, with water coming into the truck," he said. "I didn't
know where I was."
Lofton had gotten out first and was on the bank, calling to him. He followed
the sound of her voice and paddled to safety.
Williams said he had no history of seizures and does not drink alcohol.
His doctor, who has treated Williams from childhood, made the connection to
Chantix.
Williams said he was considering suing Pfizer. His lawyer, Kristian Rasmussen
of Birmingham, Ala., said he was aware of at least one other Chantix accident,
involving a deliveryman who fell out of a moving truck.
The FDA has received more than 3,000 reports of serious problems involving
Chantix, but Pfizer said that had to be put into context, since more than 5
million people in the U.S. had taken the medication.
The company said that no direct cause and effect had been proved between the
drug and the problems.
The FDA is most concerned about reports of mental health problems, including
more than 400 cases involving Chantix users who reported suicidal thoughts and
more than 30 who killed themselves.
Yet many patients report success with the medication.
Kathy MacInnis, 44, of Kingston, Mass., said she had been smoking for more
than 30 years and quit on New Year's Day.
"Without Chantix, I had never been able to quit," she said. "It just put me in
a calm place."
She was smoking close to two packs a day when her 12-year-old daughter
confronted her.
"She came home from school and said her health teacher asked her if her
parents smoked, because she could smell it on her," MacInnis said. "That was
my turning point."
MacInnis videotaped her story for Pfizer but she said the company did not pay
her other than covering the costs of traveling to New York for an interview
session.
She reported no unpleasant side effects while taking the medication, only
vivid dreams that some call "Chantix dreams."
"The first few days, I kind of felt funny," said MacInnis. "You kind of feel
high."
http://www.latimes.com/features/health/la-na-smokedrug25-2008may25,0,4540550.story