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David Collins, a 59-year-old Indiana man, began taking Chantix in October 2007 after his doctor prescribed it to help him stop smoking.

Shortly after he began taking the medication, the normally easygoing, married father of two began experiencing mood swings and became aggressive and easily agitated.

On Jan. 3, 2008, his wife, Linda, left for work shortly before 7 a.m. She returned home around 11:30, expecting to have lunch with David. When she couldn't find him inside their house, she went out to the garage.

She found her husband in his van, covered in blood and dead from a self-inflicted gunshot to his head.

Linda Collins is suing Pfizer, the manufacturer of Chantix, alleging that the company failed to warn consumers that the popular smoking-cessation prescription medication may cause serious psychiatric symptoms, including erratic behavior and suicidal thoughts.

The lawsuit, filed in July in U.S. District Court for the Southern District of Indiana, is the first of what may be a torrent of claims.

Kristian Rasmussen, a pharmaceutical plaintiffs' attorney who is representing Linda Collins, said his firm, Cory Watson Crowder & Degaris in Birmingham, Ala., has received more than 1,400 inquiries from Chantix users and their families.

In addition to the Collins case, the firm has filed suits in state courts in Louisiana and New York. It has 200 cases, all involving suicides or suicide attempts by Chantix users.

Other clients include the family of a woman who used a handgun to kill herself in front of her two children, and a father in his late 30s who committed suicide in front of his wife and 8-year-old son.

"Tragically, almost without explanation, these people commit suicide, often without any prior diagnosis of family or individual history of depression, psychosis or any other type of psychological conditions," Rasmussen said.

Since its introduction in May 2006, Chantix has become hugely popular in the war against nicotine addiction. More than 4 million people have been prescribed Chantix, and sales of the medication totaled $883 million last year.

But the product has also raised serious public health concerns.

Red flags

On Feb. 1, 2008, the Food and Drug Administration issued an alert that "serious neuropsychiatric symptoms have occurred in patients taking Chantix."

The symptoms include "changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicides."

"It appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms," the FDA stated.

Chantix's main ingredient is varenicline tartrate. Available by prescription only, it is a "nicotinic receptor partial agonist." It is designed to decrease nicotine craving.

A study in May 2008 by the Institute for Safe Medication Practices, a prescription drug watchdog group based near Philadelphia, reported that in the fourth quarter of 2007, varenicline accounted for 988 serious injuries reported to the FDA, more than any other single drug.

Thomas Moore, a senior scientist at ISMP, said the drug's effect is not fully understood.

"There are numerous brain receptors with which Chantix is involved directly or indirectly, and all the wanted or unwanted effects are poorly understood and not expected," he commented.

In addition to psychiatric problems, adverse drug event reports for varenicline include accidents and injuries, vision disturbances, heart rhythm disturbances, seizures, muscle spasms and severe allergic reactions.

The Federal Aviation Administration has banned pilots and air traffic controllers from using Chantix; the drug has also been banned for use by commercial drivers.
"What does that mean for the soccer mom carting three children around in the back of her SUV or minivan?" Rasmussen asked.

Warnings revised

On Feb. 1, 2008, Pfizer strengthened its Chantix labeling to include stronger warnings about neuropsychiatric symptoms. In May 2008, it revised the warning again, advising physicians to discontinue Chantix immediately if patients become agitated, depressed or suicidal.

Marc Grossman is a senior partner with The Sanders Firm, a personal injury firm in Mineola, N.Y., which filed five Chantix suits in New York state court in early August. He said Pfizer's revised warning is still inadequate.

"I don't think the drug should be on the market," he stated.

Moore agreed: "The existing warnings are not adequate to deal with the actual and potential risks outlined in our paper."

Grossman's firm is investigating 175 claims involving suicides or attempted suicides by Chantix users.

David Benjamin, a toxicologist in Newton, Mass., said the biggest challenge for plaintiffs' lawyers will be proving causation in cases where Chantix users committed suicide.

Some of the psychiatric side effects – such as anxiety and depression – may also occur in people who stop smoking without taking Chantix, he noted.

A Pfizer spokeswoman did not return phone calls seeking comment.

Questions or comments can be directed to the writer at: nora.tooher@lawyersusaonline.com