By Linda Martin, Ph.D. and Gretchen LeFever Watson, Ph.D, April 25, 2025 | From: The Disinformation Chronicle

FDA Commissioner Martin Makary can protect healthcare costs and increase public trust in federal health agencies by policing drug labels so patients and physicians have more complete drug safety information. Updating labels with the latest science should have minimal costs to taxpayers as the FDA already collects a great deal of safety data even though both drug companies and FDA employees seem to ignore it.

For example, FDA has disregarded its own data linking antidepressants and violence, no doubt misleading too many doctors to reach for a prescription pad when patients feel down. But if Americans knew more about these drugs’ side effects, they would probably stop overusing them.

Prozac is a case study, having first come to market in early 1988 to become one of the most popular medicines in the selective serotonin reuptake inhibitor (SSRI) class of antidepressants. Fueled by a medical perception that it offered a benign side-effect profile, Prozac prescriptions rose exponentially during 1990s. But the drug took a hit to its credibility in 2006 when, spurred to act after its British counterpart banned Prozac for kids, the FDA placed a “boxed warning” on Prozac’s label to highlight risk of suicide in children, adolescents, and young adults.

Nonetheless, the World Health Organization added Prozac to its model list of essential medicines in 2007. At the height of its popularity, Prozac sales reached $2.8 billion annually, with physicians writing over 24 million prescriptions in 2022, making it the country’s 22nd most popular drug.

Despite the black box warning, anyone looking through a public FDA database called FAERS (FDA Adverse Event Reporting System) would have serious concerns that antidepressants are neither as safe nor as effective as the FDA would have patients believe. FAERS documents physician, patient, and drug maker reports of serious side effects.

For Prozac these FAERS reports include adverse events that amount to relatively strong signals related to congenital, psychiatric, and nervous disorders.

By 2024, the FDA’s FAERS had received reports of 190 homicide-related adverse events due to Prozac use, including 96 completed homicides. On top of this, FAERS documents 4,920 suicide-related reports and 374 completed suicides reported for Prozac. FAERS also has many more reports of potential violence-triggering events for Prozac like hostility, aggression, and agitation.

The FDA claims that only 10% of adverse events get reported, so the true numbers of people harmed is likely much larger than what can be found in FAERS. We calculate the actual numbers of homicide-related adverse events due to Prozac at 19,000, with 1,000 completed homicides. Similarly, there may have been nearly 50,000 suicide-related adverse events and 3,700 completed suicides due to Prozac.

We need FAERS monitoring because adverse drug events often become known only after a drug is released on the market. During clinical trials, companies test a new drug in a small, select group of patients, but once the FDA gives approval, all kinds of people start taking them. And that’s when side effects start popping up.

For example, about seven years after the FDA approved GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone) a study combined all known data and found Avandia increased risk of heart attacks and death in some people. Drug safety monitoring is an ongoing process and the signal that Avandia was causing these problems was not obvious when the FDA first approved the drug.

In the case of Prozac, FDA is expected to closely monitor the FAERS database for signals of serious side effects—risks which are now glaring and include homicide. What can be more dangerous? Similar breakdowns in safety monitoring likely exist not just for Prozac but for all antidepressants, making this problem reminiscent of the FDA's failure to warn about the dangers of opioids to reign in prescriptions that caused an epidemic.

The label for Prozac, sold generically as fluoxetine, does warn about suicide risks among young people but the boxed warning fails to alert physicians that FAERS data reveals the potential for violence in users. This omission appears to place FDA out of compliance with the federal code, which mandates the agency put this information in a black box warning:

The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved…. Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box.

Researchers affiliated with the Southern Network of Adverse Reactions (SONAR) pharmacovigilance center have uncovered dangerous side effects in blockbuster drugs and delayed safety warnings for others. For example, it took the FDA 40 years to warn the public about serious toxicities from a class of commonly prescribed antibiotics that includes Cipro. This may never have happened without patients filing FAERS reports.

Drug companies obviously are in no rush to find out if their products are causing harm once the FDA approves them for the public, because doing so hurts their bottom line. SONAR published a 2021 study in The Lancet that identified 20 serious adverse reactions in patients taking 15 different drugs. Over 750,000 patients were injured resulting in $38 billion in legal settlements.

Twelve of the medicines were mandated to add a “boxed warning” to the drug label, while another six were removed from the market. Companies that manufactured four of these products paid a combined $1.7 billion in criminal fines for failing to inform the FDA and physicians what their medicines were doing to patients. Annual sales of these drugs dropped by 84 percent or were wiped out for those pulled from shelves.

There is no justification for the FDA’s failure to provide patients and doctors a full and transparent label about the true risks and benefits of antidepressants like Prozac, one of the most widely prescribed medicines in America. Risk in users for committing violent acts exists in the FDA’s own data. True and under-highlighted risks for other drugs is known by the FDA as well.