Zoloft: Health Risks and Legal Information

Zoloft (sertraline hydrochloride) is an antidepressant doctors prescribe to treat depression, obsessive-compulsive disorder, posttraumatic stress disorder, and anxiety. Pfizer manufactures this selective serotonin reuptake inhibitor (SSRI).

The Food and Drug Administration (FDA) approved the drug in 1991. But the agency has issued numerous alerts about the side effects of Zoloft since then. Some patients have sued the drug manufacturer over Zoloft’s serious side effects.

This article discusses the benefits and side effects of Zoloft. It also describes the history of Zoloft lawsuits, including the injuries plaintiffs claim they experienced while taking the drug.

Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you have been harmed by Zoloft or another drug, you may have a legal claim. Discuss your situation with a product liability attorney near you. An attorney can determine if you have a valid claim and help pursue fair compensation.

Why Do Doctors Prescribe Zoloft?

Zoloft is one of the most popular SSRI antidepressants on the market. Doctors prescribe Zoloft to treat various conditions.

Specifically, patients take Zoloft to help with the following:

• Depression
• Major depressive disorder
• Obsessive-compulsive disorder (OCD)
• Panic disorder
• Posttraumatic stress disorder (PTSD)
• Premenstrual dysphoric disorder
• Social anxiety disorder (SAD)

Zoloft helps many people deal with depression and social anxiety. But some Zoloft side effects are severe. Some are so serious that patients have filed product liability lawsuits against Pfizer, Inc.

Zoloft Side Effects

Most prescription drugs have adverse side effects. Usually, these are minor. Most patients agree that the benefits of their medications outweigh the side effects.

With Zoloft, there are some minor side effects. But unfortunately, others can prove fatal. Minor side effects of Zoloft include the following:

• Difficulty sleeping
• Nausea
• Dry mouth
• Drowsiness

Most patients have no problem dealing with these side effects. However, some are more problematic. We discuss these in detail below.

Zoloft Health Risks

There are adverse health risks of taking Zoloft. This is in addition to the side effects discussed above.

The risks of using Zoloft include:

• An increased risk of suicidal thoughts or actions
• Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
• Mania
• Seizures
• Weight loss
• Sexual problems, including impotence

Seek immediate medical advice if you experience any of these health risks. You should never stop taking Zoloft suddenly. Doing so may result in harmful side effects. Your healthcare professional should slowly decrease your dose as necessary.

Zoloft and Pregnant Women

In 2006, the FDA also announced that taking antidepressants during pregnancy may cause a severe condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs. Babies born to women who took Zoloft during pregnancy were six times as likely to develop PPHN.

Studies also show that taking Zoloft during the first trimester can cause birth abnormalities. For example, a study in 2017 found that infants born to women who took Zoloft during pregnancy had an increased risk of developing cleft palate, club foot, cleft lip, and septal defects.

Clinical trials also show that Zoloft can cause heart defects that can be life-threatening for a baby. Always talk to your physician before taking any prescription medications during pregnancy.

Zoloft FDA Alert: Serotonin Syndrome

In July 2006, the FDA issued an alert regarding Zoloft. It stated that some patients taking the drug may suffer a life-threatening condition called serotonin syndrome. This condition can occur when patients take SSRIs (such as Zoloft) with medicines used to treat migraine headaches.

Signs and symptoms of serotonin syndrome include:

• Restlessness
• Hallucinations
• Loss of coordination
• Fast heartbeat
• Increased body temperature
• Rapid changes in blood pressure
• Overactive reflexes
• Diarrhea
• Coma
• Nausea
• Vomiting

Serotonin syndrome may be more likely to occur when starting or increasing an SSRI or a triptan dose. If you take migraine headache medicines, ask your healthcare professional if your medication is a triptan.

Zoloft and an Increased Risk of Suicidality

In October 2004, the FDA directed all antidepressant drug manufacturers to change their labels to include boxed warnings regarding suicidal behavior in young people. Studies show that children and adolescents taking Zoloft are at a greater risk of having suicidal thoughts.

The FDA ordered drugmakers to alert healthcare providers about this increased risk of suicidality. Pfizer Pharmaceuticals added a black box warning to Zoloft’s prescribing information in response to the FDA’s advisory.

Other studies have shown that adults who take Zoloft are also at risk of worsening depression and increased suicidality. It’s essential to monitor these patients, especially when treatment begins, and when their doctor increases their dosage.

Zoloft-Related Injuries

Patients who take Zoloft have reportedly suffered a wide array of side effects. When manufacturers fail to report these side effects, patients can sue for damages.

The three main side effects plaintiffs cite in Zoloft lawsuits are:

• Suicidal thoughts and behavior
• Congenital disabilities
• False and misleading advertising

Some users claim that Zoloft provided no relief, despite the drug manufacturer’s claims that the drug successfully treats depression. In many cases, patients experience the harmful side effects of the drug without the advertised benefits.

Liability for Zoloft Injuries

When a drugmaker fails to warn doctors and patients about their antidepressant medication’s side effects, they open themselves up to liability. Patients who suffer an injury from taking a drug can sue the manufacturer.

Like all product manufacturers, drugmakers must warn consumers about the foreseeable risks of harm their products pose. This includes potential side effects and health risks. The court may hold them liable for damages if they fail to warn.

Zoloft Lawsuits

In April 2012, more than 40 plaintiffs filed suit against Pfizer. The plaintiffs alleged that Zoloft caused severe congenital disabilities in babies born to women who took the drug during pregnancy. The courts consolidated the lawsuits into a multi-district litigation case in the Eastern District of Pennsylvania.

In June 2017, the federal judge overseeing the multi-district litigation case dismissed the lawsuits. The court held that there wasn’t sufficient evidence proving that Zoloft caused congenital disabilities in the plaintiffs’ children. By July of that same year, the federal courts dismissed the remaining cases related to Zoloft and congenital disabilities.

California Resident Sues Pfizer for False Advertising

A woman filed a class action lawsuit against Pfizer. The plaintiffs’ attorney filed the claim in the Northern District of California in San Jose. The plaintiffs alleged that Pfizer lied about Zoloft’s effectiveness. The plaintiff’s counsel argued that the drug worked no better than a placebo and that the drug company lied about it.

Pfizer denied the claims and asked the court to dismiss the complaint. The judge dismissed the complaint in September 2013.

Judge Dismisses Two Lawsuits Claiming Pfizer Withheld Information From the FDA

In 2016, two plaintiffs in West Virginia sued Pfizer, alleging that the drugmaker withheld information from the FDA regarding Zoloft’s approval. The plaintiffs argued that the drug company knew the drug was dangerous and ineffective.

The judge found that the FDA thoroughly evaluated the drug for its safety and effectiveness. The court dismissed the two lawsuits in February 2017.

Timeline of Zoloft News, Research, and Legal Updates

Follow along below for significant updates involving Zoloft.

September 2021: Zoloft May Decrease Risk of Suicide in Young People

Early research indicated that Zoloft may increase the risk of suicide in children and young adults. But a Swedish study published in September 2021 suggests the opposite.

Researchers found a minor spike in suicidal thoughts in early treatment for younger patients. But they also found that the odds of having these thoughts significantly declined over time. The research concluded Zoloft can help decrease suicidality in young adults and children. The same is true for other SSRIs.

June 2020: Extreme Shortage of Zoloft and Sertraline During COVID-19

The FDA reported shortages of Zoloft and Sertraline, the generic form of Zoloft. Pfizer, the company that manufactures Zoloft, said it was able to fill existing prescriptions. But the drugmaker feared it couldn’t handle the increasing number of prescriptions.

Other drug companies were not so lucky. Accord Healthcare reported a shortage in doses of sertraline. A lot of people suffered from anxiety and depression during the pandemic. Drug companies weren’t able to keep up with demand.

April 2016: Philadelphia Judge Dismisses Lawsuit Claiming Zoloft Caused Congenital Disabilities

A federal court in Pennsylvania dismissed more than 300 Zoloft lawsuits. The plaintiffs sued Pfizer for their infants’ congenital disabilities. They argued Zoloft caused their children’s injuries.

The federal judge found that there was not enough scientific evidence linking the drug and the plaintiffs’ injuries. The 300 cases were part of multi-district litigation (MDL) and included patients from New Jersey, New York, and Pennsylvania.

The plaintiffs argued that Zoloft caused their children’s health issues, including spina bifida and heart defects.

April 2015: St. Louis Jury Finds in Favor of Pfizer, Inc.

The first trial for plaintiffs who sued Pfizer for birth injuries took place in St. Louis. Plaintiffs argued that Zoloft caused their babies’ health issues.

This was the first such case that made it to trial. The jury decided that there was not sufficient evidence to prove the drug caused the children’s injuries. This ruling would have a significant impact on later cases.

June 2014: Study Shows Potential Risk of Cardiac Issues for Newborns

In 2009, BMJ published a study showing that babies born to mothers who took Zoloft were three times as likely to develop cardiac issues. There have been conflicting studies on this issue over the years.

In June 2014, a study in the New England Journal of Medicine reported an increased risk of cardiac issues and congenital disabilities for these babies. But the risk didn’t seem to be much higher than other selective serotonin reuptake inhibitors (SSRIs).

January 2013: California Class Action Lawsuit Against Pfizer

In January 2013, a group of plaintiffs in California asked a federal court to approve two class action lawsuits. One would be for California residents and the other for all citizens of the USA. The plaintiffs filed their product liability litigation in San Jose against Pfizer Inc., alleging fraudulent marketing.

The claimants argued that Pfizer lied by saying Zoloft was more effective at treating depression than a placebo. The complaint alleged that Pfizer withheld information about studies showing their drug was not effective at treating depression and other mental health disorders.

The courts dismissed the personal injury cases. It would have been the first lawsuit demanding refunds for a prescription drug that didn’t work the way the drugmaker advertised.

January 22, 2007: Study Links Antidepressants to Bone Fractures in Older Patients

A study in 2007 found that certain antidepressants increase older patients’ risk of bone fractures. Canadian researchers found that older patients who take SSRIs are twice as likely to suffer bone fractures.

The study, which appeared in JAMA, found that older adults taking Zoloft had an increased risk of fractures in the hip and spine.

July 2006: Combined Use of Zoloft and Migraine Medicines Risky

The FDA issued a public health advisory concerning the use of Zoloft and other antidepressants. The FDA said combining SSRIs and triptans can lead to a life-threatening condition called serotonin syndrome. Triptans are medications doctors use to treat migraine headaches.

July 2006: Zoloft Birth Defect Claims

In July 2006, the FDA issued a public health advisory. It warned about the potential side effects of using Zoloft during pregnancy. The FDA said the drug caused an increased risk of persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs. This condition can prove fatal in some infants. There were also claims that pregnant women were at an increased risk of having babies with heart defects.

A Lawyer Can Help With Your Zoloft Lawsuit

If you or your child suffer an injury due to Zoloft use, contact an experienced drug and medical device attorney today. You must file your claim before the statute of limitations period expires. These statutes dictate how long a plaintiff has to file suit against a potential defendant.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many attorneys offer free consultations.