Zoloft (sertraline) is an antidepressant medication is a member of the serotonin-specific reuptake inhibitor (SSRI) class, which works by increasing serotonin levels in the brain. Though Zoloft was intended to be safer than older medications, it has been shown to increase the risk of suicide, birth defects and other serious side effects.
The FDA has issued multiple warnings about Zoloft and has required changes to its prescribing information and Pfizer, Zoloft’s manufacturer, has faced lawsuits for injuries caused by the medication.
Zoloft Side Effects
Zoloft may cause common side effects including nausea, diarrhea or constipation, insomnia, agitation, drowsiness or dizziness, headache, weight changes, sweating, dry mouth and sexual dysfunction.
It may also cause more severe side effects or complications which may be serious or life threatening such as:
- Suicide Risk – increased risk of suicide in those with depression, especially in those who are under 25, have a history of suicide or who are bipolar. This information is included in a black box warning issued by the FDA and printed on all prescribing information.
- Birth Defects – increased risk of birth defects may include miscarriage, heart and lung defects including persistent pulmonary hypertension of the neonatal (PPHN), and brain, skeletal or abdominal defects such as anencephaly, craniosynostosis or omphalocele. May also include autism spectrum disorder and serotonin withdrawal syndrome in infants.
- Serotonin Syndrome – caused by a buildup of serotonin in areas of the brain which may be severe or life-threatening. Symptoms include changes in mental function, severe nausea or vomiting, elevated blood pressure, increased or irregular heart rate, muscular symptoms, and sudden or severe fever.
- Withdrawal or Discontinuation Syndrome – sudden discontinuation may cause symptoms such as dizziness, nausea, diarrhea, chills, headache, cognitive deficits, and electrical or other odd skin sensations. When possible, Zoloft should be slowly tapered over a period of time.
Severe or sudden side effects should be reported to a medical professional and may require emergency treatment.
Zoloft is the brand name of the generic medication, sertraline. It is a member of the SSRI class of antidepressants and is approved for major depression, anxiety and panic disorders, post-traumatic stress disorder and premenstrual dysphoric disorder in adults and for obsessive-compulsive disorder in adolescents and adults. It has also been used “off-label” for bipolar disorder, premature ejaculation, headaches and other conditions.
Neurotransmitters like norepinephrine, dopamine and serotonin are used as chemical messengers by the brain cells. Antidepressants work by increasing neurotransmitter levels in the brain’s mood centers. SSRI medications were invented to only affect serotonin which was thought to be make it more effective and safer, with fewer side effects.
Since Zoloft was introduced in 1994, it has been used in millions of people. Though most people do not have severe side effects, it has shown to cause serious injury in some patients. Beginning in 2004, the FDA has issued multiple warnings about the risks of Zoloft and Pfizer has faced multiple lawsuits for injuries caused by the medication and for improper marketing practices.
Zoloft Suicide Risk
Zoloft has been shown to increase the risk of suicide in those with depression, especially in those who are under 25, have a history of suicide or who are bipolar. The FDA issued a “black box warning” in 2004, which required that information about the risk of suicide be printed at the top of prescribing information, enclosed in a black box.
Zoloft Birth Defects
Zoloft was the second of the SSRI medications and was thought to be fairly safe during pregnancy because it does not affect norepinephrine. It was used in millions of pregnant women but has been found to have an increased risk of miscarriage and birth defects.
An FDA warning about Zoloft birth defects was issued in 2006 and it has since been listed as a Pregnancy Category C medication. These medications should not be taken by pregnant women unless absolutely necessary.
Birth defects linked to Zoloft use may include:
- PPHN or Persistent Pulmonary Hypertension in Newborn, fatal in 10% of infants
- HLHS, HRHS/Hypoplastic Left/Right Heart Syndrome, may be fatal in infants
- Anencephaly (missing portion of brain, skull and scalp), fatal shortly after birth
- Spina Bifida (missing part of vertebrae with spinal cord exposed), requires surgery and is 15% fatal by age 4
- Cleft Palate or Lip (missing portion of upper front jaw or roof of mouth), may require surgery
- Omphalocele (abdominal organs on outside of body), requires surgery and sometimes fatal
- Scoliosis (curved spine), may require surgery
- Club feet (feet curl inwards), may require surgery or extensive therapy
- Autism Spectrum Disorder/ASD or Delayed Development Disorder/DDD
- Withdrawal symptoms in infants
Zoloft Serotonin Syndrome
Zoloft and other SSRIs may cause serotonin to build up in the brain which results in “serotonin syndrome”. This is most common when Zoloft is taken with other serotonin medications including cough suppressants, migraine treatments and some herbal supplements.
Serotonin syndrome symptoms may include:
- Unexpected high fever
- Increased heart rate, abnormal heart beat
- Loss of balance or coordination
- Confusion or hallucinations
Severe cases of serotonin syndrome may be life-threatening. To reduce the risk, all medication use should be discussed with a doctor.
Patients who take SSRIs for a long period of time may become physically dependent. When Zoloft is suddenly discontinued, serotonin withdrawal symptoms can occur. Some withdrawal symptoms may last for a long time.
Symptoms of SSRI discontinuation syndrome may include:
- Chills or shivers
- Brain “zaps”
- Electric sensations in skin
Many physicians recommend tapering off of Zoloft rather than sudden discontinuation. This may help minimize the withdrawal symptoms.
Common Side Effects of Zoloft
Zoloft also has a number of common side effects which are related to serotonin activity. Most are mild-to-moderate and will go away with time.
Common side effects include:
- Diarrhea or constipation
- Weight loss or gain
- Dizziness and drowsiness
- Insomnia and agitation
- Dry mouth
- Sexual dysfunction (males and females)
Bothersome or persistent side effects should be reported to a health care professional.
Pfizer is facing a number of lawsuits related to Zoloft use. Patients or loved ones of those harmed by Zoloft may be eligible for compensation for medical costs, lost wages and pain and suffering. People or loved ones of those who experienced harm due to Zoloft, should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.