Chantix Continues To Be a Cancer on Pfizer
Even with lawsuits mounting, the anti-smoking drug is still for sale.
Maybe if that drug killed people just like the dirty habit does.
Pfizer (PFE), which makes the smoking-cessation drug Chantix, isn't considering anything of the sort, despite mounting lawsuits on the behalf of Chantix users that have committed suicide or attempted suicide.
Last week, three more lawsuits added to Pfizer's list of problems with its would-be wonder drug. But Chantix is a far cry from what it once promised to be. In early 2007, analysts said they expected the drug to reach blockbuster status after it had only been on the market for a year. Soon after, reports of strange side effects started to creep up and sales slid just as quickly.
Chantix had sales of $524 million for the first nine months of 2009, down 21%, or $142 million, from the year-prior. Pfizer blames the sales drop on the slew of labeling changes that the company has had to make over the last two years.
Pfizer has been forced to change the labeling on Chantix, known as Champix in Europe, three times since it hit the market in 2006. The latest label change came in July 2009 when the FDA required the company to put a "black box" warning on the drug, the most severe warning the agency hands out.
From the time Chantix was approved in May 2006 to July 2009, when it received its warning, the FDA received 98 reports of suicide related to the drug, along with 188 suicide attempts. This is on top of the hundreds of complaints the FDA received concerning psychosis, aggression, and hallucinations.
For the past three years, reports have been popping up that describe weird scenarios of people committing out-of-character acts of violence or hurting themselves after starting the drug. One FDA report tells of two women who developed aggressive, erratic behavior shortly after starting the drug and then returning to normal once they stopped use of the drug.
The latest lawsuits were filed last week in New York State Supreme Court in Manhattan. According to the complaints, Pfizer intentionally, recklessly, and negligently concealed or misrepresented the Chantix health risks. This adds to a slew of other lawsuits that have been consolidated by the US Judicial Panel in October 2009, when 34 different Chantix suits that were pending in 16 different federal districts were put together into one multidistrict litigation suit.
Most of the lawsuits that involve Chantix place blame on the company for neglecting to properly notify the public of the side effects of the drugs and for not properly researching the drug prior to seeking approval. Pfizer's testing of Chantix prior to approval didn't include any patients that had depression or schizophrenia, despite the fact that many depression patients are heavy smokers.
So is the benefit of using Chantix to quit smoking great enough to account for the risk of suicide and depression? Pfizer certainly thinks it is, and so far it has been able to prove to the FDA that the risk/reward profile falls in its favor.
But the FDA isn't sitting quietly back while Chantix wreaks havoc on the lives of those who take it -- the agency has ordered Pfizer to do more testing in patients with depression problems and to increase the awareness surrounding the side effects of the drugs. Pfizer did not respond to requests for comment.
In reality, though, it's difficult for the FDA to remove a product from the market once it has been approved without the cooperation of the company. "Only the Secretary of the US Department of Health and Human Services may suspend the approval of a new drug application if there is an imminent hazard to the public health," said an FDA spokesman in an email to Minyanville. "The only other route for non-voluntary withdrawal of a drug product is quite time-consuming, requiring formal notices and an opportunity for a hearing. Therefore, the primary mechanism for removing risky medical products from the market requires FDA to obtain voluntary agreement from the manufacturer."
While smoking is not the best option for overall public health, Chantix may not be the best option to help you quit. Fortunately for smokers who are ready to kick the habit, other methods are available that won't make you jump off a bridge.
Update from Pfizer, 1/21: "We stand firmly behind Chantix, a proven aid to smoking cessation specifically developed to help adults over 18 quit smoking. At all times, Pfizer has clearly communicated important information about the safe use of Chantix, which is available only with a prescription. Smoking is a public health crisis – it is the leading cause of premature death in this country. We intend to vigorously defend this medicine, which has helped many smokers around the world quit."
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