Published June 01. 2011 4:00AM Updated June 01. 2011 5:11PM
A smoking-cessation pill whose active ingredient was developed by scientists at Pfizer Inc. campuses in Groton and New London has been removed from a list of state-approved remedies in France following questions about the drug's side effects.
The pill, called Champix in Europe and Chantix in the U.S. but known generically as varenicline, has been tied to everything from violent rages to suicidal thoughts. Reported side effects of Chantix have led to hundreds of lawsuits nationwide, including one filed last month in Pennsylvania following a 2009 murder-suicide.
French health Minister Xavier Bertrand said Tuesday he decided to remove the drug from a list of approved treatments available for reimbursement through his country's social security funds because of questions about its safety.
"It will no longer be covered by health insurance," Bertrand told a French television network, according to Reuters news service.
Chantix contributed $755 million in worldwide sales to Pfizer's bottom line last year, up from $700 million the year before. In the U.S., however, sales declined 15 percent, from $386 million to $330 million, as reports of side effects stunted market growth.
In another controversy surrounding the drug, the U.S. Food and Drug Administration announced late last week that Pfizer had been asked last year to resubmit thousands of reports on adverse events related to Chantix, a request that came after it was revealed the company had not sent the information through proper channels.
The adverse-event information had been sent as a periodic safety summary rather than as a report required within 15 days for unexpected or fatal events, the FDA said.
Still, the FDA said the updated information - which more than doubled the reported number of suicides tied to Chantix through the third quarter of last year - didn't change its views of the benefits and risks of the smoking-cessation aid.
"These reports confirm what we already knew about Chantix," the agency said in a statement. "At this point, based on the data, FDA does not have any new safety concerns with Chantix, though those that have been established remain under active review."
The Institute for Safe Medication Practices, a nonprofit group that tracks the safety profile of marketed drugs, released a study of Chantix's side effects last month that tied the Pfizer product to a much higher number of serious events than previously had been known.
"The ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly," explained Ed Silverman in the pharmaceutical blog Pharmalot. "Instead, the drugmaker apparently coded the suicides as 'expected adverse events' among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to the FDA."
The safe-medication group said Chantix first reached its radar screen in 2006 - the year the smoking-cessation aid received FDA approval - and became a red flag a year later, when it accounted for more serious side effects than any other drug on the U.S. market.
The FDA issued a black-box warning about Chantix two years ago, encouraging patients and doctors to monitor mood changes that could lead to suicidal thoughts. At the time, the agency ordered that Chantix undergo further clinical studies to determine if these effects are more pronounced in those with psychiatric histories than in the general population.
The FDA last year warned Pfizer about lax practices in reporting serious side effects from such drugs as pain medication Lyrica, erectile-dysfunction treatment Viagra and cholesterol pill Lipitor. The warning came after inspections of data at Pfizer's corporate headquarters in New York City in 2009, though problems with Chantix reportings weren't mentioned at the time.
Pfizer resubmitted to the FDA in July 2010 a large volume of adverse-event reports that initially did not allow the agency to complete a comprehensive safety evaluation.
"Pfizer has complied fully with FDA requirements regarding adverse events reports it has received related to the use of Chantix," the company said in a statement released previously.
Pfizer did not respond to questions about France's decision to stop reimbursing patients using the smoking-cessation drug, or about general concerns regarding the safety of Chantix. It also didn't respond to questions about potential liabilities related to Chantix lawsuits.
Despite France's move, Pfizer's stock price rose to its one-year high of $21.45 a share on Tuesday on the New York Stock Exchange, a 2.5 percent increase.