The Timeline of the SSRI Lawsuit

Early SSRI Research and Marketing

Despite Prozac® being the only drug approved for use in children over the age of eight years old, other drugs, including Lexapro® and Celexa®, were marketed as safe for children. By 2004, early research showed that SSRIs, Prozac® in particular, increased the risk of suicidal thoughts in children and adolescents, prompting the FDA to issue an official warning. In 2006, this warning was expanded to include children, adolescents, and young adults up to the age of 24 years old.

Despite the severe risks discovered through early research of SSRIs, they are still among the most frequently prescribed drugs in the country.

Other research in the early 2000s showed that women who took an SSRI antidepressant during their pregnancy were at a higher risk of their child being born with persistent pulmonary hypertension of the newborn, or PPHN. This is a serious and life-threatening condition that prevents the newborn’s lung from properly adjusting to breathing outside the womb. The U.S. Food and Drug Administration (FDA) issued an official warning in 2006 about the risks of PPHN from SSRI use during pregnancy.

Despite the severe risks discovered through early research of SSRIs, they are still among the most frequently prescribed drugs in the country. Serious side effects and risks of SSRIs include suicidal thoughts, birth defects, and drug dependency. Although SSRIs are not considered addictive drugs, they are likely to result in high rates of dependency.

First SSRI Drugs Prescribed

Prozac®, manufactured by Eli Lilly and Company in the late 1980s, was the first SSRI antidepressant approved to treat depression, obsessive-compulsive disorder (OCD), and panic disorder. More than 25 years later, it is still one of the most frequently prescribed antidepressants. Shortly after Prozac®’s release, Paxil®, manufactured by GlaxoSmithKline, was approved by the FDA to treat major depression, panic disorder, OCD, social anxiety disorder, and posttraumatic stress disorder (PTSD).

In the late 1990s, Celexa®, manufactured by Forest Laboratories, was approved to treat mood disorders in adults. Despite not being approved for pediatric use, Forest was accused of marketing Celexa® as safe for children. In 2010, the company settled criminal and civil complaints related to the promotion of the drug for over $300 million.

Lexapro®, another Forest Laboratories medication, was approved in 2002 to treat major depressive disorder in children over the age of 12 and adults. Zoloft®, manufactured by Pfizer, was also approved in 2002, and was marketed as a safer alternative to Prozac®.

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The more recently developed medications are thought to be safer alternatives than their predecessors, but are still associated with many severe complications. Common SSRI side effects may include:

• Fatigue
• Dry mouth
• Nausea
• Diarrhea
• Weight fluctuations
• Insomnia
• Drowsiness
• Rash
• Headaches
• Sexual Dysfunction

Despite the risk of these potentially serious side effects, SSRIs are still typically prescribed as the primary treatment for depression, anxiety, and other psychological disorders.

FDA Warnings and Requirements

Since being made available to the U.S. market, the FDA has issued several safety warnings and packaging requirements for SSRI medications.

Suicidal Behavior

• 2004 - The FDA began requiring SSRI drugs’ packaging to carry a black-box warning regarding the increased risk of suicidal thoughts and suicide in children and adolescents. The black-box warning is the FDA’s strongest warning before revoking approval of a drug.
• 2006 - The FDA expands the black-box warning to include the risk of suicidal thoughts and suicide in anyone age 24 or younger.
• 2007 - The black-box warnings were updated again to state that there is a higher risk of suicidal thoughts, attempted suicide, and suicide during the first two months of taking the medication.

Warnings about Serotonin Syndrome

• 2006 - The FDA issued a warning regarding the potential for a dangerous interaction between SSRIs and triptans, a class of medications used to treat migraines. The warning stated that the interaction of the two drugs can lead to serotonin syndrome, or an overdose of serotonin. This reaction can occur within minutes of the interaction and includes symptoms of high blood pressure, hyperthermia, increased body temperature, increased heart rate, and shock. Due to the sudden onset of symptoms, serotonin syndrome is often fatal.

Birth Defects

• 2005 - After many adverse events had been reported, the FDA issued a warning about Paxil® and the potential for serious birth defects.
• 2006 - The FDA issued a warning about the increased risk of PPHN when SSRIs are taken during pregnancy.

Although numerous studies have linked SSRI use during pregnancy to an increased risk of autism spectrum disorder and heart defects, the FDA has not yet issued an official warning.

Journal Articles Concerning SSRIs

Numerous studies have shown links between SSRIs and increased risk of suicide and birth defects.

• A 2001 study published in The Journal of Clinical Psychiatry found that 8% of 533 patients admitted for psychiatric services suffered from symptoms of mania or psychosis related to antidepressants.
• In 2003, the United Kingdom Committee on Safety of Medicines (CSM) reported that SSRIs increased the risk of suicidal thoughts and self-harm in children.
• A 2005 study conducted by the Medicines and Healthcare products Regulatory Agency (MRHA) reported that SSRI use may increase the risk of suicide.
• Another study published by JAMA Pediatrics in 2011 found that exposure to SSRIs during the first trimester increased the risk for autism spectrum disorder.
• The journal Pediatrics published a study in 2014 that showed an increased risk of autism spectrum disorder, especially for boys, with SSRI exposure during pregnancy.
• JAMA Pediatrics published a study in February 2016 that reported an increased risk of autism spectrum disorder when SSRIs were taken during the second or third trimester. The study found the risk of boys born with autism spectrum disorder was greater than for girls.

SSRI Litigation

There have been many claims filed against the manufacturers of SSRIs for complications experienced by patients and their families.

Prozac® - Manufactured by Eli Lilly & Company

• 2000 - Eli Lilly paid over $50 million to settle more than 30 claims concerning suicide, murder, and other violent behaviors.
• 2003 - The company settled a case in South Carolina with the family of a teen who had committed suicide just three weeks after beginning to take Prozac®.
• Lawsuits have continued to mount after the link between the drug and possible birth defects was discovered.

Lexapro® and Celexa® - Manufactured by Forest Laboratories

• 2006 - Fifty-seven lawsuits involving suicide from Celexa® use were transferred to the Eastern District Court of Missouri. As of the publication of this article, 32 of these cases have been settled.
• 2010 - Forest Laboratories settled a lawsuit regarding illegal marketing practices of the two drugs for $300 million. Celexa® was marketed as safe for children, though it was never approved by the FDA for pediatric use.
• 2012 - Lawsuits claiming birth defects, including limb defects, caused by Lexapro® use during pregnancy were filed in St. Louis.

Paxil® - Manufactured by GlaxoSmithKline (GSK)

• 2009 - Jury awarded $2.5 million to Kilker family after their son was born with heart defects thought to be caused by the mother’s use of Paxil® during pregnancy.
• 2010 - Over 800 cases involving birth defects from Paxil® use during pregnancy settled for about $1.2 million per plaintiff.
• 2011 - GSK paid $3 million to settle investigations conducted by the Department of Justice into illegal marketing of the drug.
• GSK has also settled numerous suicide cases for a total of $390 million.

Zoloft® - Manufactured by Pfizer

• Pfizer continues to maintain that Zoloft® does not cause birth defects.
• Several hundred lawsuits have been consolidated for multidistrict litigation (MDL) in a Pennsylvania district court, many of which are still pending.
• A majority of the claims involve heart defects in children born after in vitro exposure to Zoloft®.

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If you or a loved one has suffered due to the severe risks and side effects of an SSRI antidepressant, please contact a skilled pharmaceutical attorney in your area today to discuss your legal options.