http://www.nationalpost.com/news/story.html?id=2760945

VICTORIA - A Canadian woman has launched a class-action lawsuit against the Pfizer drug company, claiming her 22-year-old daughter committed suicide after taking the prescription drug Champix to help her quit smoking.


Patricia Clow of Colwood, B.C., and two other women in British Columbia are suing Pfizer, alleging the company failed to provide adequate warning to Canadians about the potential risk of serious injury and death related to Champix. The suit also alleges Pfizer was negligent in its testing, design, labelling, manufacturing and marketing of the medication.


The claims in the lawsuit have not been proven in court.


In June, 2009, Heidi Megan Clow received a prescription for Champix. Four months later, in the early hours of Oct. 4, 2009, without showing any signs of depression, according to her mother, Heidi committed suicide by taking an overdose of painkillers.


"I would like to see it taken off the shelves," said Patricia Clow. "And at the very least, I would like to educate people about the risks."


Heidi wanted to be as healthy as possible, said her mother. "She was changing everything in her life. She had lost weight and was working out every day, running downtown, reading all the packaging on everything she ate or drank. And quitting smoking was part of that."


Ms. Clow insists her daughter wasn't depressed on the evening of Oct. 3, the last time she saw her alive.


"I dropped her off at her friend's house and she had a big smile on her face. And when she left his house, she made plans to see him the next day. She had tickets to a concert later in the week. So whatever made her do it, she just snapped like that."


When Heidi didn't show up for work on Monday, Oct. 5, Ms. Clow went to her apartment. She couldn't get in - and is thankful for that now.


"I have an image of her smiling and walking away, looking beautiful, after I dropped her off. I was thinking to myself, 'How did I get so lucky? She was the perfect daughter.' "


Heidi had left her mother a note, telling her she loved her, telling her she was sorry. But her death was a shock to everyone who knew Heidi, Ms. Clow said. "Nobody saw it coming."


Afterwards, Clow learned that Heidi had complained to a friend that the drug was "f-ing her up," but the friend thought this meant the drug was giving her an upset stomach.


Ms. Clow started looking at Champix websites and found information on links between the drug and the potential for Depression and suicide, she said.


"I wonder if the Pfizer shareholders would give Champix to their children," said Ms. Clow.


The class-action suit alleges that Pfizer failed to follow up on evidence that arose during clinical trials of the drug. One of the participants in a 2004 study committed suicide, says the claim. In a March, 2005 study, there were multiple reports of adverse psychiatric effects among test subjects, including cases of acute psychosis, the suit alleges.


In July 2009, the U.S. Food and Drug Administration required Pfizer to insert a "black box" warning into its labelling about the risk of suicide or psychiatric harm. Pfizer did not strengthen the warning on its Canadian label - which remains inadequate, the plaintiffs charge.


Pfizer said in an e-mailed statement that it is aware of the lawsuit but that it would be inappropriate to comment on specifics at this early stage.


The company stated that all medications carry potential risks and patients should consult with their doctors to determine what's right for them.


Pfizer noted the benefits of quitting smoking are immediate, and that Champix is a proven prescription aid that has helped many smokers quit. Since it was introduced in Canada in April 2007, about two million prescriptions for the drug have been written.


The company said it works closely with Health Canada to get information to patients, is vigilant in monitoring adverse effects and has extensive systems in place to collect, review and report findings.


"Pfizer acted responsibly and appropriately at all times in connection with the development, approval and marketing of Champix," the company stated.


Likewise, Health Canada, also responding by e-mail, said it has posted warnings - as recently as Jan. 6, 2009 - suggesting patients and caregivers keep note of any unusual thoughts, especially those related to depression, aggression and self-harm.


Health Canada is working with Pfizer to update product information available for health professionals and patients using the drug. The federal department posted a notice stating that between April, 2007 and November, 2007, it received 107 reports of adverse reactions to Champix, 46 of which were psychiatric in nature - including 14 involving aggression, suicide or depression.


The agency also noted, however, that symptoms like depressed mood, insomnia, irritability, frustration, anger and anxiety are often reported while quitting smoking, with or without drug treatment.


Alicia Pickering of Sechelt, B.C., is also part of the class-action suit, alleging she became deeply depressed and catatonic within days of taking Champix. Pickering took a leave of absence from work, thought of committing suicide and was ultimately hospitalized.


A third plaintiff, Nicole McIvor of Princeton, was prescribed Champix in December, 2007 and became severely depressed. In May, 2008, she tried to kill herself by smashing her car into an oncoming logging truck.


According to the statement of claim, Pfizer obtained regulatory approval to sell Champix in Canada under the Food and Drugs Act in January 2007. The drug is supposed to work by inhibiting nicotine receptors in the brain. It acts as both "agents" and "antagonist" to decrease cravings and psychological rewards associated with smoking.



Read more: http://www.nationalpost.com/news/story.html?id=2760945#ixzz0k57f46uZ