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FDA Changes Chantix Warning Again


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The stop-smoking drug Chantix is responsible for severe psychological side-effects

Many people are given prescriptions to help them with a specific medical condition or problem. However, sometimes medications can cause more harm than good. When this happens and a drug that is prescribed to a patient actually causes harmful side effects, the drug manufacturer should be held liable.

Chantix is prescribed to many people to help them stop smoking. However, the drug may result in serious side effects.

How Chantix Works

Chantix was designed to help smokers quit by diminishing smoking cravings through blocking the pleasurable effects of smoking in the brain. Since the early trials, however, this drug has been linked to harmful drug side effects in the brain.

Many patients on Chantix complained of the following changes after taking the drug, including:

  • Depression
  • Anxiety
  • Suicidal thoughts
  • Confusion
  • Panic attacks
  • Extreme fear
  • Difficulty sleeping
  • Emotional changes
  • Changes in behavior, especially increased aggression and hostility

It appeared that Chantix was impairing many patients’ thoughts and behavior, and that it led to some harming themselves and taking their own lives.

The Food and Drug Administration (FDA) Takes Action…Then Reverses Course

In 2009, the Food and Drug Administration (FDA) required Pfizer to include a black box warning on Chantix. The black box warning—the most stringent of warnings—was meant to warn users of psychological issues such as hostile behavior, suicidal tendencies and depression.

In 2016 the FDA dropped the black box warning requirement. However, Pfizer must still continue to include psychiatric side effects in the standard precautions section of its label. The decision to discontinue the black box warning was reportedly based on a study—funded by Pfizer and GlaxoSmithKline—that found that people who used Chantix did not have a significantly higher rate of psychiatric side effects when compared to people who used a placebo.

Pfizer Settled Lawsuits for Chantix Psychiatric Side Effects

Despite the findings of the most recent study, Pfizer settled hundreds of cases for psychiatric side effects. Reports indicate that the company set aside more than $275 million to settle these claims.

Patients who are hurt by specific drugs and who did not receive adequate warnings about the potential side effects that the drug manufacture knew or should have known about may have a claim for damages. If this has happened to you, please contact us today via this website.

Jason F. Abraham
Managing Partner, Hupy and Abraham

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