SSRI Antidepressants – Pregnancy, Side Effects & Birth Defects

Since the FDA approved the first SSRIs, or selective serotonin reuptake inhibitor, in 1991, this class of antidepressants has gained in popularity. But SSRIs are also associated with serious side effects, including life-threatening birth defects, sexual dysfunction, and suicide. An SSRI pregnancy describes the taking of the antidepressant while pregnant. Recent studies suggest that doing so may expose the fetus to a range of long-term health consequences.

What are selective serotonin reuptake inhibitors (SSRIs)?

Serotonin reuptake inhibitors are a class, or type, of antidepressant medication. SSRI antidepressants have evolved over the years, and are considered a third-generation antidepressant. They are developed to treat depression – they have been shown most effective in treating severe, not mild depression – but are also prescribed for panic attacks, anxiety, and personality disorders, such as obsessive-compulsive disorder (OCD).

The first SSRI, Prozac, was introduced in the United States in 1988. Today, Prozac, the most popular of SSRIs, is the third-most prescribed antidepressant in the United States. Since the introduction of Prozac, other SSRIs have soared in popularity. By 2005, they were the most prescribed drugs in the United States. There are a number of SSRI antidepressants available today, and popular name brands include Prozac, Zoloft, and Paxil.

SSRIs earn their name from how they work: this type of antidepressant blocks re-absorption of serotonin. Serotonin is a brain chemical that is naturally produced in the body and influences mood. SSRIs work by blocking the brain (specifically, the neural receptors in the brain) from re-absorbing serotonin, thus allowing the chemical to improve a person’s mood. However, each specific SSRI medication works differently – and not all work for every person. If one SSRI is ineffective, a patient discontinues use and may try another SSRI. Some SSRI medications may interact with other drugs, so anyone taking one of these antidepressants must be monitored under medical supervision.

An overview of SSRI antidepressants

There are about a dozen SSRIs currently available. These medications are listed below by their generic forms and corresponding tradenames:

• Citalopram: Celexa, Cipramil, Cipram, Dalsan, Recital, Emocal, Sepram, Seropram, Citox, and Cital
• Dapoxetine: Priligy
• Escitalopram: Lexapro, Cipralex, Seroplex, Esertia
• Fluoxetine: Depex, Prozac, Prozac Weekly, Fontex, Seromex, Seronil, Sarafem, Ladose, Motivest, and Flutop
• Fluoxetine combined with the atypical antipsychotic olanzapine: Symbyax
• Fluvoxamine: Luvox, Fevarin, Faverin, Dumyrox, Favoxil, Movox, Floxyfral
• Paroxetine: Paxil, Paxil CR, Seroxat, Sereupin, Aropax, Deroxat, Divarius, Rexetin, Xetanor, Paroxat, Loxamine, and Deparoc
• Sertraline: Zoloft, Lustral, Serlain, and Asentra

The three most common SSRIs in the U.S.:

• Prozac: Prozac, or fluoxetine, is the third-most prescribed antidepressant in the United States. Prozac users report many of the common side effects of SSRIs, which include anorexia, anxiety, drowsiness, insomnia, nausea, nervousness, sexual dysfunction, tremors, and weakness.
• Zoloft: First introduced in 1991, Zoloft (sertraline) is manufactured by Pfizer and has been linked to an increased risk for serious birth defects in children who were exposed to the drug in utero (the drug is FDA-approved for use by those who wish to continue an SSRI pregnancy). Though using Zoloft while pregnant may negatively affect the baby in the first trimester, and perhaps even before the mother even knows she is pregnant, most studies so far have focused more on the use of Zoloft after the 20th week of pregnancy, where it has been associated with an increase in the risk for heart defects.
• Paxil: Manufactured by GlaxoSmithKline, Paxil was first introduced to the U.S. market in 1992. Though Paxil was approved to treat depression, it soon became the first SSRI approved to also treat panic attacks. The FDA has issued a public safety warning about use of Paxil during pregnancy, and the drug has been classified as Class D for pregnant women.

Side effects from SSRI medications

Like all prescription drugs, SSRIs have been linked to a range of side effects. For both men and women, the potential side effects of SSRIs include decreased libido and difficulty reaching orgasm; men may also experience erectile dysfunction. In teenagers, SSRI antidepressants have been linked to suicide ideation (suicidal thoughts) and suicidal behavior.

Other mild side effects of SSRIs include:

• Agitation
• Diarrhea
• Drowsiness
• Dry mouth
• Excessive or increased sweating
• Fatigue
• Headaches
• Insomnia
• Nausea
• Rash
• Weight loss or weight gain

SSRI and pregnancy linked to birth defects

In pregnant women, SSRIs may slightly increase the risk for damage to a fetus, even in the earliest stages of pregnancy.

Some of the most serious birth defects linked to an SSRI pregnancy:

• Anencephaly
• Autism spectrum disorder (ASD)
• Cleft lip / cleft palate
• Craniosynostosis
• Persistent pulmonary hypertension of the newborn (PPHN)
• Respiratory distress at birth
• Septal defects, including atrial septal defects (ASD) and ventricular septal defects (VSD)

SSRI black box warnings and other FDA alerts

To protect the public from serious and even life-threatening SSRI side effects, the FDA has issued ever-evolving safety updates, communications, and other FDA warnings. These have also included mandatory black-box warnings – additions to each drug’s warning label detailing very serious or life-altering side effects linked to the medication.

• In 2004, the FDA required SSRI manufactures add a black-box warning to inform the public of the risk of suicidal thoughts and behavior in children and adolescents.
• In 2006, the FDA sounded the warning regarding SSRI interaction with Triptan medications (migraine medications). When used together, SSRIs and Triptans can cause a serotonin overdose known as serotonin syndrome – a potentially fatal side effect.
• In 2006, the FDA also issued an official public health advisory warning of the link between SSRI antidepressants and persistent pulmonary hypertension of the newborn (PPHN), a very serious birth defect that can cause brain and organ damage.

Antidepressant lawsuits

Unforeseen and severe complications from SSRIs have fueled thousands of lawsuits around the nation. The most commonly litigated drugs are the most popular – Prozac, Zoloft and Paxil – since more patients take these medications than any other antidepressants.  Birth defects resulting from a combination of SSRI treatment and pregnancy are among the most commonly alleged injuries.

In most cases, plaintiffs who have filed these SSRI lawsuits seek compensatory damages. These are economic damages that compensate, or reimburse, for the financial hardship associated with injuries: costly hospital bills, surgeries and medical treatments, medications, and associated lifestyle changes. SSRI lawsuits may also seek other damages, such as punitive damages. These are designed to hold the drug manufacturers responsible for negligence and fraud in failing to warn the public of the risk of known side effects, including birth defects.