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On January 14, 2010, three new personal injury lawsuits were filed against Pfizer Inc. claiming its smoking cessation drug Chantix caused attempted suicides and death. The lawsuits, filed in New York State Supreme Court in Manhattan, state that at the time the plaintiffs took Chantix, Pfizer did not inform doctors and patients about risks it allegedly knew were related to the drug, including depression and thoughts of suicide.

Two lawsuits claim the plaintiffs tried to kill themselves as a result of using Chantix. The third is a wrongful death lawsuit filed on behalf of Indiana resident, claiming she committed suicide after using Chantix.

The lawsuits claim that each of the plaintiffs used the drug properly. They also claim that in each case the plaintiffs and their doctors were “not aware and through diligent efforts were not able to discover the risk of serious injury, and/or depressed mood and/or suicide associated with and/or caused by Chantix.”

On May 11, 2006, the FDA approved Chantix to assist people quit smoking. On November 20, 2007, the FDA began reviewing reports of suicidal behavior submitted to the administration by the drug maker, Pfizer, as well as instances of other side effects associated with Chantix.

On July 1, 2009, the FDA announced that the agency will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts. The new requirement is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., the manufacturer of Chantix, had already updated its labeling following the beginning of an FDA investigation into the potential side effects in 2007 after receiving several reports of psychiatric problems in patients.

Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Last fall, the FDA also began looking into scores of patient reports about blackouts and injuries while taking Chantix.

The Federal Aviation Administration later banned use of Chantix by pilots and air traffic controllers. The drug’s label also warns that patients may be too impaired to drive or operate heavy machinery.

Chantix was approved in 2006, and reached sales of $846 million in 2008.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer.

Pfizer said it made the revised label warnings in agreement with the FDA and is immediately making the information available to health care providers and patients.

FDA regulators announced on June 4, 2009, that they are still investigating the safety of Pfizer’s anti-smoking drug Chantix, a probe that began last year after thousands of patients reported blackouts and other complications.

Chantix was among the 20 medications under investigation for potential safety issues, according to an updated list from the FDA. The FDA is investigating reports of injury, visual impairment and other problems connected with Chantix, which is designed to help smokers quit.

Pfizer said it’s continuing to track side effects with the medication. “As with all our medicines, we work with the FDA to ensure our labeling reflects the latest safety information,” Sally Beatty, a spokeswoman for the New York-based company, said in a statement.

Regulators initially began investigating Chantix in 2007 after receiving numerous reports of psychiatric problems, including suicidal thoughts. That prompted Pfizer to update the drug’s labeling that patients should be monitored for unusual behavior.

The FDA last fall began looking into scores of patient reports about blackouts and injuries while taking Chantix. A nonprofit group highlighted 1,001 reports to the FDA of serious injuries linked to the drug over a three-month period, more than for the 10 best-selling brand name drugs combined. Pfizer said at the time that the high number of reports might be linked to greater publicity about the side effects.

The Federal Aviation Administration (FAA) later banned use of Chantix by pilots and air traffic controllers.

Current warnings on the drug say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications.

The FDA began publishing quarterly lists of drugs under investigation last year to give consumers and doctors early notice about emerging safety issues. Drugs on the list have a “potential safety issue,” but have not necessarily been directly linked to a problem.

First approved in May 2006, Chantix quickly became one of the fastest growing products for Pfizer, with sales $846 million in 2008.