Pfizer Ignored Depressed Patients in Tests of Chantix Side Effects

Shay Morrigan | February 21st, 2012

One of the main complaints in current Chantix side effects lawsuits is the fact that manufacturer Pfizer failed to test their product on the mentally ill or those with depression. By doing so, the company neglected to study the safety of their smoking-cessation drug in a large population of the people who would eventually be using it.

Meanwhile, since its approval in 2006, Chantix has been the subject of hundreds of reports of serious side effects like Chantix suicide, aggression, and heart problems.

Pfizer failed to study Chantix side effects in depressed individuals

Laura Pratt and Debra Brody of the National Center for Health Statistics conducted a government survey in 2010 on smokers who are depressed. Overall, they found 43 percent of adults over 20 with depression smoked.

Yet Pfizer failed to test their product on those with a recent history of depression, a move that has been criticized by plaintiffs in Chantix litigation who allege to have suffered psychiatric side effects, including Chantix suicide ideation.

Unfortunately, after the FDA approved the drug, it failed to request a follow-up study on Chantix side effects in mentally ill patients, even though the agency’s own safety reviewer reported that excluding this population may have undermined the clinical trials.

FDA requires additional studies on Chantix suicide

By mid-2009, the FDA had received reports of nearly 100 cases of Chantix suicide, 200 attempted suicides, and 5,000 other serious psychiatric side effects. They required Pfizer to conduct additional trials on people with a history of mental illness.

Independent study indicates link between drug and Chantix suicide

Though Pfizer has long defended itself against Chantix litigation by maintaining that side effects like depression and suicidal thoughts in those with mental illness may be caused by the mental illness itself, or even by nicotine withdrawal, a study published in November 2011 disagreed.

Researchers from the Wake Forest Baptist Medical Center analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban, or nicotine replacement drugs, which were reported to the FDA from 1998–2010. Of all the reports, 90 percent were linked with Chantix. In addition, 92 percent of completed suicides were associated with Chantix use.

“The FDA’s own data show that Chantix is more dangerous than other treatments to stop smoking,” said Dr. Curt Furberg, one of the study’s authors.

In November 2011, the FDA reported that two federally funded clinical trials studying more than 26,000 patients showed that Chantix did not increase depression and suicidal thoughts compared to other smoking-cessation treatments.

The FDA acknowledged that the reports came only from those patients who were hospitalized, which excludes any and all patients suffering from side effects that did not go to the hospital.