U.S. Antidepressant Drug Labels Still Lag Behind Canada

0
519

A trial underway in Massachusetts for Lindsay Clancy, the mother who killed her children and then attempted suicide following the birth of her third child, has put a spotlight on postpartum depression and its treatment. While few details have been released, the public is already asking whether North Carolina’s Andrea Faust—like Clancy—was taking an SSRI when she killed her child during the postpartum period, given reports that she is planning an insanity defense and had recently been hospitalized for psychiatric concerns.

The Clancy trial quickly exposed multiple weaknesses in our mental health system: the subjective nature of psychiatric diagnoses, questionable practices of suicide hotlines, and the risks of both starting and stopping psychiatric medications. As members of the Southern Network of Adverse Events (SONAR), a postmarketing drug surveillance team at the University of South Carolina College of Pharmacology, we are aware of an unmentioned oversight.

Since 2004, SSRI drug labels in Canada have warned about the risk of suicide as well as “violence,” including “harm toward others,” without age restrictions. Health Canada issued these warnings after reviewing reports from SSRI manufacturers and other corroborating evidence, including lawsuits linking the drugs to suicide and violence. In the United States, comparable “harm to others” warnings do not exist.

U.S. labels for the exact same drugs limit the suicide warning to individuals 24 and younger and make no mention of “harm toward others.” Yet buried in the fine print of the medication guides given to patients by the pharmacy are references to “violent” behaviors.

A woman reads the instructions for her pills

SSRI medications may be an important treatment for many people struggling with mental health problems, including postpartum depression. Medical ethics, however, requires that patients receive accurate—not misleading—information about potential risks. Why is it acceptable to omit or bury known and potentially life-threatening risks on an American drug label when the same risks are stated explicitly on the Canadian label?

Innumerable civil cases have been settled out of court for SSRI-induced suicide and violence. In a smaller number of criminal cases, the drugs have been legally implicated in murder.

As of July 2026, the FDA’s Adverse Event Reporting System (FAERS) includes 643 SSRI-related reports of actual homicide and 746 reports of homicidal ideation. FAERS is estimated to capture only about 10 percent of actual cases; they are not confirmed through medical records. Are these homicide-related numbers not sufficient to warrant investigation?

Drug companies selling SSRIs in the United States have already acknowledged an SSRI association with violence, given that their medications and have acknowledged that their medications are associated with “harm to others,” evidenced by the Canadian labels—which have carried this warning for more than 20 years now. There is no reason to believe these drugs affect people differently simply because they live in the United States.

Federal law does not require a “definitive causal connection” between a drug for the FDA to issue a warning. It requires a warning as soon as there is “reasonable evidence of a causal association.” Based on FAERS data, court cases, and Canadian SSRI labels—not to mention accumulating reports of personal experiences of violent SSRI reactions, as expressed in memoirs like May Cause Side Effectsthe FDA should promptly require that SSRI labels be updated to match those used in Canada.

Expanding the boxed warnings to explicitly advise patients and families to watch for behavioral or emotional changes—including suicidal and violent ideation and behavior—can mean the difference between life and death, freedom and prison, corporate liability and corporate deniability.

We do not know what legal consequences, if any, should follow for Lindsay Clancy or Andrea Faust. We do know that SSRI manufacturers and their executives should be held legally accountable for failing to warn U.S. patients of the risk of “harm to others.” For more than twenty years, these companies have failed many patients, including Lindsay Clancy.

***

The author is grateful for the assistance of Dr. Linda Martin, a SONAR colleague, in preparing this essay.

***

Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.

LEAVE A REPLY