SSRI Antidepressants: Legal and Safety Concerns

Selective serotonin reuptake inhibitors, or SSRIs, are widely prescribed to treat depression and anxiety. But they’ve also been at the center of controversy. Government-mandated label warnings, lawsuits and safety concerns have raised questions about risks.

SSRIs work by increasing the amount of serotonin in your brain, which can improve mood and overall well-being. As a result, the U.S. Food and Drug Administration (FDA) has approved them to treat several mental health conditions.

Common side effects of SSRIs include sleep disturbances, gastrointestinal issues, sexual dysfunction, weight changes and increased anxiety, among others. These issues are often temporary. However, they can also cause rare but severe side effects.

The FDA has issued multiple warnings, investigated reported risks and faced legal pressure related to the safety of antidepressants. These concerns have included increased suicide risk in young people, issues with pregnancy, birth defects, heart complications and persistent sexual side effects.

Black Box Warning of Suicide Risk in Youth

In 2004, the FDA started requiring a black box warning — the agency’s most stringent type of warning — regarding suicidality in young people taking antidepressants, including (but not limited to) SSRIs.

The FDA added the warning after reviewing 372 studies with nearly 100,000 participants. They found that about 4% of those taking antidepressants had thoughts of suicide or acted on them, compared to only 2% of those taking a placebo. This raised important safety concerns about SSRIs and other antidepressants.

While subsequent studies highlighted heightened suicide risk in children under the age of 18, there was no increased risk for adults over 24 years old. In fact, those over 65 were more protected from suicidal thoughts once on antidepressants.

Persistent Pulmonary Hypertension of the Newborn

The FDA rejected adding a warning about persistent pulmonary hypertension of the newborn (PPHN) to SSRI labels in 2011. When a baby is born and takes their first breath, their lungs need to adjust to getting air and oxygen. PPHN happens when the blood vessels in the lungs don’t open properly. This limits the oxygen that reaches the baby’s brain and vital organs. PPHN is a serious issue that requires immediate medical attention.

The FDA said that some studies have indicated a possible link between SSRI use during pregnancy and PPHN, while others have found no apparent connection. Due to these mixed findings, the FDA concluded that the evidence isn’t strong enough to warrant changes to how SSRIs are prescribed.

Celexa Heart Warnings for Adults

In 2011 and 2012, the FDA made important updates to the warning label for Celexa (citalopram hydrobromide). They discovered that taking more than 40 mg a day could lead to serious heart problems, particularly affecting the heart’s rhythm or number of beats per minute. Patients over the age of 60 have a lower maximum recommended dosage, which is detailed on the drug’s label.

Further, a warning was issued stating that any person with specific health conditions is at an increased risk of their heart taking more time to contract and relax than it should (QT prolongation). However, the FDA concedes that the need for citalopram may outweigh the risk for patients with certain health issues, regardless of dosage.

No other SSRI labels required the changes.

Request for Warning About Lasting Sexual Side Effects Denied

In 2024, Antonei Csoka, a scientist at Howard University, took legal action against the FDA, claiming that the agency had failed to act on a petition he helped write back in 2018. This petition called for new warning labels on two popular types of antidepressants, SSRIs and SNRIs, stating that sexual side effects might continue even after they stop taking the medication.

Current labels warn of sexual side effects while taking the drugs but say nothing about the side effects lasting after people discontinue their use. While the FDA did give a temporary response in 2018, it hasn’t made any further moves since then.

However, the U.S. District Court for the District of Columbia ruled that Csoka’s complaint was a grievance about government operations in general and that he did not experience an informational or physical injury as a result of the lack of follow-up. As a result, the court dismissed the case on March 31, 2025.

Many SSRI lawsuits centered on heightened suicide risks for adolescents, pregnancy and birth defect side effects, and withdrawal or discontinuation syndromes. Typically, these lawsuits followed new warnings from the FDA or studies that suggested an increased risk of serious side effects.

Currently, Drugwatch knows of no attorneys taking on cases related to SSRIs.

SSRI Lawsuits Combined Into Multidistrict Litigation

Popular antidepressants like Prozac, Paxil and Zoloft have been involved in SSRI lawsuits claiming serious side effects. Similar lawsuits were grouped in multidistrict litigations (MDLs) to handle these cases more efficiently. This process helps expedite the legal proceedings through the courts.

There were five different SSRI MDLs beginning with Prozac in the 1990s. A federal judge closed the last SSRI MDL in 2020. Individual lawsuits have also played out in courts around the country.

SSRI Lawsuits Settled Privately

Eli Lilly reportedly paid $20 million to settle claims that Prozac led a man to carry out a mass shooting at his former workplace in 1989. The company fought in court for more than 20 years to keep the settlement secret.

An investigative report by the Indianapolis Star found that many SSRI lawsuits were resolved through private settlements, meaning they didn’t go to court. There was only one lawsuit that went to trial. That case occurred in 2001 and involved the company GlaxoSmithKline (GSK), resulting in a settlement of $6.5 million. But that, too, was settled after GSK appealed the verdict.

It’s important to note that while SSRIs have been blamed for suicidality and aggression, studies on the subject tend to discuss that the situation isn’t black and white. Researchers generally state that the majority of people taking SSRIs will not commit violent crimes and that the indications for SSRI use, gender, history of violence and other factors may affect these risks. You and your doctor should discuss the risks and benefits of the medications and ensure appropriate monitoring.

If you believe you’re experiencing negative side effects from an SSRI, contact your prescriber immediately. Never stop taking your SSRI or change your dose without first talking to your healthcare provider. Abruptly discontinuing SSRIs could trigger issues like ADS, which may include anxiety, agitation, dizziness, flu-like symptoms, insomnia, nausea and sensory disturbances.

It’s important to be alert to the signs and symptoms of SSRI harm. The possible serious complications of SSRI use include:

• Suicidal thoughts or behavior
• Serotonin syndrome
• Antidepressant Discontinuation Syndrome (ADS)

You should schedule regular appointments with your healthcare provider to monitor the effectiveness and mild side effects of your SSRI.

Serotonin syndrome is more likely to occur when SSRIs are combined with certain other medications, illicit drugs or supplements like St. John’s wort.

Ensure that all your healthcare providers are aware of any medications and supplements you are currently taking.