Chantix, blamed in suicides, called poorly tested

Linda Ware wanted to stop smoking. Two years ago, she went to her doctor to get help and began taking a new prescription medication aimed at fighting nicotine addiction: Chantix. She experienced hallucinations a few days later. While driving in a remote area with her cousin, she saw a vision of a sign that read, "God is in the realm."

Ware pulled off the road, commanded the relative to get out of the car, and broke out in laughter. Ware, who suffered from depression, had never acted like that, said her daughter, Cary Ussery.

The next day, a family friend found her slumped in front of her bed with a suicide note by her side. At the age of 57, Ware, a real estate agent from Cypress (Orange County), overdosed on a lethal combination of pills.

Tragedy has plagued Chantix since it was approved in 2006, even as the drug has helped some smokers kick the habit. By mid-2009, the U.S. Food and Drug Administration had received reports of almost 100 suicides, 200 attempted suicides and 5,000 serious psychiatric events. Hundreds of reports of side effects have continued to stream in this year.

A review of the drug's history shows that Pfizer Inc., the giant pharmaceutical company that makes Chantix, failed in years of clinical trials to test the product on people with mental illness or those with a recent history of depression - even though millions of smokers suffer from psychiatric problems.

Moreover, FDA regulators approved Chantix after a speeded-up "priority review" process and did not request a follow-up study on mentally ill patients using the medication, even though the agency's safety reviewer reported that the exclusion of such smokers may have undermined the clinical trials.

It wasn't until three years later, after thousands of reports of serious side effects, that the FDA told Pfizer to conduct trials including people with a history of mental illness. The agency then also slapped a black box warning, the FDA's strongest alert, on the medication.

The controversy over Chantix's side effects, particularly for smokers with mental health issues, has brought a torrent of lawsuits. About 1,000 such cases have been filed in federal court, and plaintiffs' lawyers say they anticipate bringing forward more than 1,000 additional suits. Plaintiffs in more than half of the cases say the drug led to suicides or suicide attempts, and many say they suffered psychosis, blackouts, aggression, diabetes or other problems. No cases have yet been tried or settled.

Pfizer defends drug