SSRIs Lawsuit – Birth Defects Risks

Studies have shown that use of selective serotonin reuptake inhibitors (SSRIs) may increase the risk of suicide in children and young adults.  SSRIs may also increase the risk of certain birth defects including persistent pulmonary hypertension of the newborn (PPHN) which can be fatal.

SSRI Lawsuits

Drug manufacturers of selective serotonin reuptake inhibitors (SSRIs) have faced thousands of lawsuits filed by patients and their loved ones for injuries caused by the medications.

Injuries or serious medical problems claimed in lawsuits have included:

  • Birth Defects
  • Suicide
  • Withdrawal
  • Serotonin syndrome
  • Other serious effects

Many of these lawsuits have been settled or resolved but more may remain in federal, state and local courts.  In addition, several manufacturers have faced lawsuits and fines for improper marketing of SSRI medications. Settlements, damage awards, and fines have reached into the $billions for several companies.

What are SSRIs?

Selective serotonin reuptake inhibitors (SSRIs) are used as antidepressants which work by increasing the amount of the neurotransmitter, serotonin, in certain areas of the brain.

Drugs included in the SSRI class are:

CelexacitalopramAllergan, Forest Laboratories
LuvoxfluvoxamineJazz Pharmaceuticals, Solvay Pharmaceuticals
ProzacfluoxetineEli Lilly
SarafemfluoxetineWarner Chilcott
LexaproescitalopramAllergan, Forest Laboratories

Other medications have been used in Europe or Japan but have been withdrawn from the market due to Guillain Barre Syndrome or other serious side effects.  These medications have included Upstene, Zelmid, and Normud. Another SSRI, Priligy is was used for premature ejaculation but is only effective for a short period of time and not thought to be useful for mental disorders.

Other antidepressants which work similarly to SSRIs and may have some of the same side effects include:

Serotonin–norepinephrine reuptake inhibitors, or SNRIs

  • Effexor (venlafaxine)
  • Cymbalta (duloxetine)
  • Pristiq (desvenlafaxine)
  • Savella (milnacipran)
  • Fetzima (levomilnacipran)

Atypical antidepressants

  • Wellbutrin (bupropion)
  • Remeron (mirtazapine)
  • Desyrel (trazodone)
  • Viibryd (vilazodone)
  • Brintellix (vortioxetine)

Selective Serotonin Reuptake Inhibitors (SSRIs) Linked to Birth Defects

Recent studies have shown that using of SSRIs (selective serotonin reuptake inhibitors) while pregnant increases the risk of birth defects. The birth defects associated with SSRIs include persistent pulmonary hypertension of the newborn (PPHN) and other lung and heart problems.

Women who take SSRIs during their third trimester may be six times more likely to deliver babies born with PPHN—or to have babies that would develop primary pulmonary hypertension—than women who do not take SSRIs during their third trimester.

Symptoms of PPHN include:

  • Rapid Breathing
  • Rapid Heart Rate
  • Difficulty Breathing
  • Bluish Skin
  • Heart Murmurs
  • Low Blood Oxygen Levels

PPHN is a very serious birth defect, and even with treatment a child suffering from PPHN may experience shock, heart failure, brain hemorrhage, seizures, kidney failure, organ damage and even death. Infants who survive PPHN may have long-term breathing difficulties, seizures, developmental disorders and hearing loss.

In addition to PPHN, studies have also shown that women who take antidepressants during pregnancy may give birth to children who experienced withdrawal symptoms such as seizures, tremors, gastrointestinal problems and sleep disturbances.  Some advocacy groups have also suggested that SSRI use may be linked to development of autism, though no statistical link has been proven.

SSRIs and Suicide Risk

The U.S. Food and Drug Administration (FDA) has required that manufacturers of SSRI medications and other antidepressants include a black box warning about the risk of suicide in children, adolescents and young adults up to the age of 25.  A black box or boxed statement warning is the most serious warning that can be made by the FDA. The increased risk of suicide with SSRI use appears to be worse right after medication is started or after dosage changes are made.

SSRI Withdrawal

Patients who have been on SSRI medication therapy may experience withdrawal symptoms when the drug is discontinued.  Unfortunately, little information was known or acknowledged about the chance for withdrawal and patients were told their symptoms were not related to withdrawal for a number of years.

Symptoms of SSRI withdrawal can include:

  • anxiety
  • dizziness
  • problems sleeping
  • fatigue
  • headache
  • sweating
  • vomiting or nausea
  • diarrhea
  • electric shock-like sensations

Symptoms of withdrawal appear to be worsened if the medication is discontinued suddenly.  Tapering down of dosage amounts may reduce withdrawal symptoms but, in some cases, symptoms will persist for several months.

Other SSRI Side Effects

In addition to the dangerous and potentially life-threatening side effects of SSRI medications, they may also cause a number of side effects which are milder including:

  • Nausea or vomiting
  • Constipation
  • Dry mouth
  • Dizziness
  • Sleepiness
  • Insomnia
  • Headache
  • Sweating
  • Anxiety
  • Shakiness
  • Loss of appetite

SSRI use may also lead to “serotonin syndrome” which may have more serious symptoms including:

  • agitation, hallucinations or mental changes
  • muscle twitching, loss of coordination
  • high or low blood pressure
  • racing heartbeat
  • flushing, sweating and/or fever
  • muscle rigidity
  • seizures, loss of consciousness

Any of these symptoms should be treated as an emergency as they may worsen.

SSRI Manufacturer Lawsuits

Thousands of lawsuits have been filed against SSRI manufacturers. Most of these lawsuits have been settled or resolved but more may still remain in multiple court systems.  SSRI lawsuits have included:

  • Prozac – thousands of lawsuits, $billions in fines, settlements and judgements reaching back to the 1990s for suicide, withdrawal, birth defects and other serious injuries
  • Paxil – thousands of lawsuits, GSK has paid $billions for birth defects, suicides, withdrawal and other injuries.  GSK also accused of illegal marketing practices
  • Cymbalta – 200 withdrawal lawsuits settled
  • Zoloft – 250 or more birth defect and other side effects lawsuits, less than 100 may have been settled

Though no lawsuits are currently gathering in court systems, SSRI attorneys at Seeger Weiss are watchful for harm than can potentially be caused by these dangerous drugs.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.


Since its establishment in 1999, Seeger Weiss has led some of the most complex and high-profile litigations in the U.S.