Introduced in 2002, Lexapro (escitalopram) has been prescribed to millions worldwide. This selective serotonin reuptake inhibitor (SSRI) is approved for treating major depressive disorder in adults and adolescents 12 or older, and generalized anxiety disorder in adults. Doctors may even prescribe the drug to pregnant women suffering from mental disorders.
Lexapro restores the chemical balance in the brain by increasing the brain’s serotonin levels, a chemical that influences mood. When the U.S. Food and Drug Administration (FDA) initially approved it, the medication was only to be used to treat adults. Later, the FDA approved it to treat depression in adolescents 12 or older. In 2012, the drug’s patent expired and a generic version was introduced to the market.
During the drug’s 10-year run, the controversy surrounding Lexapro and the drug’s manufacturer, Forest Laboratories, grew. In 2004, the FDA added a black-box warning to Lexapro and other antidepressants to alert patients to the increased risk of suicidal thoughts and behaviors, especially in patients younger than 25.
In 2006, the FDA issued a public health advisory noting that Lexapro and other antidepressants can cause serious birth defects if taken during pregnancy. In 2015, a JAMA Pediatrics study linked the drug to double the risk of autism spectrum disorder in babies born to mothers who took Lexapro or other SSRIs while pregnant.
In 2010, Forest was ordered to pay more than $300 million for illegally marketing Lexapro and two other drugs.
Lexapro is an antidepressant that is designed to treat both anxiety and depression. But when women take it while pregnant, their babies may suffer from autism and birth defects.
Uses of Lexapro
Lexapro is designed to improve generalized anxiety disorder (GAD), which occurs when day-to-day worries are exaggerated and become overwhelming. It also aims to improve depression, which is caused by an imbalance of serotonin levels and which affects the ability to work, sleep and enjoy once-pleasurable activities. Like other SSRIs, Lexapro works by blocking the reabsorption, or reuptake, of the neurotransmitter serotonin in the brain.
Lexapro generally takes several weeks to start working. Often the physical symptoms of depression and GAD, which include changes in sleep patterns, improve first. For most patients, it takes four to six weeks for significant changes to occur.
Common Side Effects of Lexapro
Clinical trials and studies show that patients taking Lexapro suffer from several common side effects that include headaches, nausea, insomnia and dry mouth. Problems that include dizziness and nausea are likely to go away as the body adjusts to the medication. Other side effects, including dry mouth and impotence, are less likely to go away. Some patients also complain that the drug causes decreased appetite, weight gain, vomiting, vivid dreams and a tingling sensation in arms, hands, feet and legs.
Serious Side Effects of Lexapro
Lexapro has been linked to several serious side effects that can be life-threatening, including suicidal thoughts and tendencies, serotonin syndrome and discontinuation syndrome. There is also an increased risk of autism and birth defects if taken during pregnancy.
Several studies linked Lexapro and other SSRIs to increased risk of autism and other developmental disorders in newborns and young children. In 2015, Anick Bérard and other researchers from the University of Montreal discovered women who took SSRIs while pregnant had a 200 percent increase in the risk of having a baby diagnosed with autism.
Before this pivotal study, Johns Hopkins published a study in 2014 showing women who took SSRIs while pregnant gave birth to boys who were three times as likely to be diagnosed with autism.
The FDA has listed Lexapro as a category C medication in pregnancy, meaning that animal studies have shown it to have an adverse effect on the fetus and there are no complete studies in humans. The FDA advises that pregnant and nursing mothers not take Lexapro unless the patient benefits outweigh the risks. Some experts consider Lexapro safe for pregnant women, because the risk of birth defects is low.
But researchers have found that SSRIs increase the risk of infant heart defects, including persistent pulmonary hypertension of the newborn (PPHN). PPHN is a rare condition seen in newborns whose circulatory systems do no adapt to breathing outside the womb. This leads to abnormal blood flow between the heart and lungs. Many infants born with this disorder die. Those who survive face disabilities that include cerebral palsy, erb's palsy, seizures and hearing loss. In 2006, the FDA issued an advisory warning to patients and physicians of the dangers, saying infants born to mothers taking Lexapro were six times more likely to be born with PPHN.
In addition, infants born to mothers who take Lexapro are known to have congenital heart defects, including atrial and ventricular septal defects, which disrupts the infant’s blood flow through the heart and forces the organ to work harder. Lexapro is also linked to infant neural tube defects, which can cause a malformed brain and skull, cleft palate, respiratory distress and possibly autism.
Lexapro carries a black-box warning for suicidal thoughts and tendencies. Patients taking Lexapro are known to become suicidal while taking Lexapro and other SSRIs, especially in the first weeks of treatment. The risk is so severe that the FDA issued a special warning about the risk of suicidality, or suicidal thoughts and behaviors, for patients up to age 25. The risk is even greater for patients with bipolar disorder, a family history of bipolar disorder or those who have attempted suicide previously.
Patients taking Lexapro should be aware of serotonin syndrome, a potentially life-threatening drug interaction that causes the body to have too much serotonin. This typically occurs in patients who simultaneously take two drugs that affect the body’s serotonin levels. For example, patients who take certain migraine medications, including triptans, along with Lexapro are at risk. Symptoms include restlessness, diarrhea, hallucinations, fever, vomiting and rapid blood pressure changes.
Discontinuing Lexapro rapidly can cause SSRI discontinuation syndrome, which leads to flu-like symptoms, including headache, diarrhea, nausea and chills. Patients can also experience electric-shock sensations, also called brain shivers or brain zaps, and restlessness.
Dozens of Lexapro patients have filed suit against Forest in two multidistrict litigations (MDLs) located in the U.S. District Courts in Massachusetts and Missouri; the suits allege the drug created a risk of suicide. Also, at least two nationwide class actions have been filed regarding the drug’s marketing practices. In addition, women have sued after taking Lexapro and then giving birth to a baby with birth defects.