A drug manufactured by Pfizer, Chantix, administered for smoking cessation, and known in France under the name Champix (active ingredient: varenicline) has been implicated in the onset of many serious injuries due to cardiac events and losses motor control. More than 1,000 incidents involving Chantix consumers, as well as 50 deaths have been reported in the first quarter of this year, exceeding the number of adverse events related to prescription drug.
The new report highlights this anomaly has been published in the U.S. by ISMP (Institute for Safe Medication Practices) nonprofit organization dedicated to the study of drug safety. The information is based on the databases of the FDA collected across the United Etas referring fifteen events and reactions related to traffic accidents and 52 cases involving various types of ailments.
The retrospective analysis by ISMP quarterly data since 2004 and annual surveys of the 1990s revealed that the FDA has received nearly 21 000 reports of serious drug reactions, including over 4,800 deaths.
In a statement, Pfizer has questioned the conclusions of the report, saying, "We believe that the ISMP report is based solely on accounting for adverse events occurred after placing on the market," according to the company, " These reports are often unverifiable and medical information are not sufficient to draw conclusions. "As a further argument, the pharmaceutical company argued that the ISMP report itself acknowledges that adverse event reports are not enough to prove that the drug has a side effect.
Pfizer had added a warning more severe on the label of Chantix last year, after the use of this drug has been linked to psychiatric side effects such as depression and suicidal behavior. After conducting their own investigation, the FDA issued a Public Health Alert about side effects in May this year.
In addition, the initial report from the ISMP on possible links with the accident, also issued in May 2008, prompted the Ministry of Transportation, the Federal Administration of Aviation and the Department of Defense to limit the use of Chantix. Pilots and controllers of the air traffic have been instructed to immediately stop using Chantix.
In response to the ISMP report, Pfizer launched a public relations campaign and has published full page advertisements in major newspapers refuting the ISMP findings.
Pfizer and the ISMP have jointly said that negative publicity regarding the psychiatric side effects of Chantix may have contributed to increasing the number of adverse reports submitted to the FDA this year. Pfizer also noted that another factor to consider is that "Chantix patients undergoing nicotine withdrawal, itself responsible for behavioral changes such as irritability and depressed mood."
In 2007 sales of Chantix totaled $ 883 million of turnover. By cons, comparative sales for the third quarter of 2008 with figures for the third quarter of last year shows a decline in turnover of 49% in the United States from 186 million dollars, only 96 million.
The company still maintains that the benefits of Chantix outweigh unverified risks. In the statement, Pfizer, the company says "Based on this data set, we remain convinced of the efficacy and safety of Chantix. When used as prescribed, this drug is a therapeutic option important to help patients quit smoking. "
The FDA has received a copy of the report 'lISMP a week before it is released. and it has not made any comments about it.
The new report highlights this anomaly has been published in the U.S. by ISMP (Institute for Safe Medication Practices) nonprofit organization dedicated to the study of drug safety. The information is based on the databases of the FDA collected across the United Etas referring fifteen events and reactions related to traffic accidents and 52 cases involving various types of ailments.
The retrospective analysis by ISMP quarterly data since 2004 and annual surveys of the 1990s revealed that the FDA has received nearly 21 000 reports of serious drug reactions, including over 4,800 deaths.
In a statement, Pfizer has questioned the conclusions of the report, saying, "We believe that the ISMP report is based solely on accounting for adverse events occurred after placing on the market," according to the company, " These reports are often unverifiable and medical information are not sufficient to draw conclusions. "As a further argument, the pharmaceutical company argued that the ISMP report itself acknowledges that adverse event reports are not enough to prove that the drug has a side effect.
Pfizer had added a warning more severe on the label of Chantix last year, after the use of this drug has been linked to psychiatric side effects such as depression and suicidal behavior. After conducting their own investigation, the FDA issued a Public Health Alert about side effects in May this year.
In addition, the initial report from the ISMP on possible links with the accident, also issued in May 2008, prompted the Ministry of Transportation, the Federal Administration of Aviation and the Department of Defense to limit the use of Chantix. Pilots and controllers of the air traffic have been instructed to immediately stop using Chantix.
In response to the ISMP report, Pfizer launched a public relations campaign and has published full page advertisements in major newspapers refuting the ISMP findings.
Pfizer and the ISMP have jointly said that negative publicity regarding the psychiatric side effects of Chantix may have contributed to increasing the number of adverse reports submitted to the FDA this year. Pfizer also noted that another factor to consider is that "Chantix patients undergoing nicotine withdrawal, itself responsible for behavioral changes such as irritability and depressed mood."
In 2007 sales of Chantix totaled $ 883 million of turnover. By cons, comparative sales for the third quarter of 2008 with figures for the third quarter of last year shows a decline in turnover of 49% in the United States from 186 million dollars, only 96 million.
The company still maintains that the benefits of Chantix outweigh unverified risks. In the statement, Pfizer, the company says "Based on this data set, we remain convinced of the efficacy and safety of Chantix. When used as prescribed, this drug is a therapeutic option important to help patients quit smoking. "
The FDA has received a copy of the report 'lISMP a week before it is released. and it has not made any comments about it.