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Chantix Smoking Cessation Treatment Linked to Heart Disease Risk, Questions Whether Pfizer Reported Side Effects to FDA, France Removes Reimbursement
  FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease - (06/20/11)
Chantix, Quit-Smoking Drug, Safety Concerns, Pfizer defends Chantix as study claims 72% heart risk - (07/07/11)
Up In Smoke: Pfizer's Chantix Raises Heart Risk, By Ed Silverman June 16 2011
Yet another problem for Pfizer and its controversial smoking-cessation drug. The FDA has just decided to add a warning on the product labeling about an association with a small, but increased risk of cardiovascular adverse events in patients with cardiovascular disease. These are people who, of course, should not be smoking, but they are now being told the drug may be off limits. In reaching its decision, the FDA reviewed a study in which 700 patients with cardiovascular disease received either Chantix or placebo, and the results showed the Pfizer drug was effective in helping them quit smoking and remain abstinent for up to year. But Chantix was also linked more frequently to "certain events, including heart attack" (here is the statement and data summary).
This is only the latest difficulty for Pfizer and its Chantix pill. For the past four years, the drug has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn't be issued to truck drivers taking the med (see this and this). The FDA subsequently imposed a risk management program and Pfizer added warnings.
In recent weeks, there was controversy over whether Pfizer correctly reported side effects to the FDA, which required the drugmaker to alter its methods for submitting the data (look here) and France removed from its register of medicines for which patients can be reimbursed from government funds (see this).
France pulls subsidy for Pfizer stop-smoking drug
Wednesday June 01, 2011
PARIS, May 31 (Reuters) - France will remove Pfizer's stop-smoking drug Champix from a register of treatments for which users are reimbursed from state social security funds, Health Minister Xavier Bertrand said on Tuesday.
"Questions have been raised about Champix, so I've decided it will no longer be covered by (state) health insurance," the minister said in an interview on France 2 television.
The drug, described by its maker as a non-nicotine pill, has been marketed since 2006-2007 as Champix in Europe and Chantix in the United States.
Pfizer faces legal action in the United States over the treatment. Plaintiffs say it can lead to suicide. Pfizer disputes their claims.
The U.S. Food and Drug Administration issued a statement in 2009 saying the drug should carry additional warnings advising users who experienced unusual changes in mood or behaviour to stop using the treatment or contact their doctor. (Editing by Jon Loades-Carter)
In France, Chantix Subsidies Go Up In Smoke
By Ed Silverman May 31 2011
France has decided to remove Chantix, the Pfizer smoking-cessation drug, from its register of medicines for which patients can be reimbursed from government funds. "Questions have been raised about Champix, so I've decided it will no longer be covered by (state) health insurance," Health Minister Xavier Bertrand told France 2 television, according to Reuters.
The move comes amid growing problems for Pfizer and its controversial pill, which has been named in connection with suicides and violent behaviors. Two weeks ago, a watchdog group reported that Pfizer incorrectly submitted hundreds of Chantix side effects to the FDA, raising questions about the extent to which the agency was properly briefed, although the FDA subsequently released a statement saying no safety concerns have arisen (back story).
There are also a growing number of lawsuits, such as one filed earlier this month by the children of a Pittsburgh man who killed his wife and himself in 2009 while taking the pill. According to the complaint, Sean Wain, 34, had been using Chantix for up to two weeks before he began experiencing side effects that allegedly prompted him to kill his wife and himself. The murder-suicide left behind four minor children (you can read the lawsuit here).
A Pfizer spokesperson says a statement will be forthcoming shortly. UPDATE: We received this: "Pfizer had received no prior notification of the French Health Minister's intention to remove reimbursement for Champix (the name used in Europe). This announcement came outside of the formal process and Pfizer is currently seeking immediate clarification. "In March of this year, Positive Opinion was received from the Committee for Medicinal Products for Human Use (CHMP) regarding the Champix EU Marketing Authorization renewal, stating that Champix continues to have a favorable risk-benefit profile and the EU Commission decision confirming this position is expected shortly."
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