Smoking Cessation Drug Linked to Serious Injury and Death

By: Drucilla Dyess Published: Thursday, 23 October 2008

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There has been a substantial increase in the number of serious injuries linked to Chantix, Pfizer’s smoking cessation drug, due to the incidents of seizure and loss of motor control. Over 1,000 incidents involving Chantix users, as well as 50 deaths, were reported in the first quarter of this year alone, exceeding the number of adverse events for any other prescription drug.The new report was released by the nonprofit drug-safety group known as The Institute for Safe Medication Practices (ISMP). The information was based on reports filed with the FDA from around the country that included accounts of 15 adverse events linked to road traffic accidents as well as 52 cases involving various types of blackouts.The ISMP’s analysis of quarterly data that dates back to 2004 and yearly totals dating to the 1990s revealed that the FDA has received almost 21,000 reports of serious drug reactions, including more than 4,800 deaths.In a statement, Pfizer expressed doubts about the report’s conclusions by saying, “We understand that the Institute for Safe Medication Practices report was based solely on a tally of post-marketing adverse events” and that these reports “are often unverifiable and lack sufficient medical information to draw any conclusions.” In further rebuttal, the company said that the safety-group’s report itself acknowledges that adverse event reports alone do not prove a drug caused a side effect.Pfizer added a tougher warning on the Chantix label last year after the drug was linked to psychiatric side effects including depression and suicidal behavior. After conducting their own review, the FDA issued a public health alert about these side effects in May of this year. In addition, the initial ISMP report about potential links to accidents, which was also in released May, prompted the Department of Transportation, the Federal Aviation Administration and the Department of Defense to restrict the use of Chantix. Pilots and air-traffic controllers were ordered to stop using Chantix immediately.In response to the ISMP’s initial report, Pfizer’s kicked off a public relations campaign and took out full-page ads in major newspapers to disprove the ISMP’s findings.Both Pfizer and the ISMP remarked that the negative publicity regarding Chantix and its psychiatric side effects could have contributed to the increase of adverse reports to the FDA this year. Pfizer also noted that another factor for consideration is that “Chantix patients may experience nicotine withdrawal, which can cause changes in behavior, such as irritability and depressed mood.”Although 2007 sales of Chantix totaled $883 million, when 2008 third quarter totals are compared to last year’s third quarter sales, the drug has experienced a decline of 49 percent in the U.S. going from $186 million down to only $96 million.The company still maintains that the benefits of Chantix outweigh the unverified risks. In Pfizer’s statement, the company upholds, “Based on that totality of data, we stand by the efficacy and safety profile of Chantix when used as directed, an important treatment option to help patients stop smoking.”The FDA received a copy of the ISMP report one week before it’s release to the public. However, the FDA has yet to comment on this latest report.