What is Lexapro?
Lexapro is the name brand for the generic medication escitalopram and is a selective serotonin reuptake inhibitor (SSRI) prescription antidepressant medication. It is predominantly used to treat depression and anxiety, though it may be prescribed to patients to treat other mental health disorders.
Lexapro is one of the “newer” antidepressants. The first antidepressants worked by affecting both norepinephrine and serotonin, had debilitating side effects, and were dangerous in certain conditions. SSRI medications, like Lexapro, only affect serotonin and were designed to be more effective with fewer side effects.
Lexapro works by increasing neurotransmitter activity in the brain. It is a selective serotonin reuptake inhibitor, or SSRI, which means that it only affects one type of neurotransmitter: serotonin. Serotonin regulates sleep and mood and may help provide the satisfaction sensation. Lexapro works by increasing the level of serotonin in the brain.
Though it was designed to have fewer side effects, it may also increase the risk of suicide in children and young adults and has been linked to a high risk of severe birth defects.
Lexapro is the name brand for escitalopram and is manufactured by Forest Laboratories*. Lexapro became commercially available in 2002 and quickly became Forest Laboratories’ largest generator of revenue with $2.8 billion in sales in 2008. In its first decade on the market, Lexapro generated $14 billion in revenue.
In 2009, Forest Laboratories was accused of improper marketing. The company paid $313 million in fines for promoting unapproved uses, hiding negative clinical research results, and paying kickbacks to doctors.
*Forest Laboratories became Allergan, and Allergan is now part of AbbVie.
The FDA approved Lexapro in 2002 for the treatment of major depressive disorder and generalized anxiety disorder in adults. It was approved to be both an initial and maintenance treatment for depression in adults. Lexapro was not originally approved to treat children. However, in 2009, the FDA approved Lexapro to treat major depressive disorder in youth ages 12-17.
Lexapro is not approved for use in children younger than 12.
What is Lexapro Prescribed to Treat?
Lexapro is only approved by the FDA for three usages:
- Acute and maintenance treatment of major depressive disorder in adults
- Acute and maintenance treatment of major depressive disorder in children ages 12-17
- Acute treatment of generalized anxiety disorder in adults
What is Major Depressive Disorder?
Major depressive disorder (MDD) is commonly referred to as depression. Depression is a disorder that affects a person’s mood, causing a constant feeling of sadness coupled with the loss of interest.
Symptoms of depression include:
- Loss of interest in normal activities
- Feelings of guilt or worthlessness
- Excessive crying
- Lack of energy
- Loss of concentration
- Changes in appetite
- Changes in sleep patterns
- Suicidal thoughts and tendencies
What is Generalized Anxiety Disorder?
Generalized anxiety disorder (GAD) is not just anxiety. It involves continuous, extreme worry that is tough to control, interferes with daily life, and lasts for at least six months.
Symptoms of generalized anxiety disorder include:
- Constant worry or anxiety
- Inability to make decisions
- Difficulty concentrating
- Difficulty sleeping
Lexapro is sometimes prescribed “off-label” to treat other conditions. When a medication is prescribed off-label, that means that it does not have FDA approval to treat that condition. Federal law allows for medications to be prescribed for non-approved conditions, but pharmaceutical companies are prohibited from marketing medications to treat those non-approved conditions.
Conditions for which Lexapro has been prescribed off-label include:
- Obsessive-compulsive disorder (OCD)
- Eating disorders
- Panic disorder
- Posttraumatic stress disorder (PTSD)
- Premenstrual dysphoric disorder (PMDD)
Before prescribing Lexapro for any of these off-label uses, doctors should justify their reasoning and discuss it with their patients.
Like all medications, Lexapro can cause side effects in people who take the medication. Most of these side effects are mild and will go away on their own over time. Unfortunately, some of the side effects caused by Lexapro are serious and may be life-threatening.
Mild side effects include:
- Diarrhea or constipation
- Weight changes
- Dizziness and drowsiness
- Fatigue and/or insomnia
- Dry mouth
- Sexual dysfunction (both males and females)
Like all SSRIs, Lexapro may cause serious side effects in some people.
Those serious side effects may include:
- Birth Defects
- Lexapro withdrawal
- Serotonin Syndrome
Lexapro and certain other SSRIs were initially considered much safer for pregnant patients because they had no effect on norepinephrine. They were widely used in pregnancy until they were found to increase the risk of miscarriage and certain birth defects, some of which may be fatal.
Prescription medications are categorized by the U.S. Food and Drug Administration (FDA) as A through D and pregnancy category X.
- Category C medications have shown birth defect risk in animals and there are no adequate studies in humans, but the potential benefits of the medication may outweigh potential risks.
The use of SSRIs during the first trimester of pregnancy is linked to an increased risk of miscarriage. Some studies have also suggested that these women may also be at risk of preterm birth or low-weight birth. Use of the medications in late pregnancy can lead to withdrawal symptoms in the infant such as tremors, high startle reflex, excessive crying, feeding difficulty, and even seizures.
Lexapro was originally approved as a Class B pregnancy category medication. In 2006, the FDA issued a warning about the risks of Lexapro-related birth defects, and it is now classified as a Pregnancy Category C medication. Lexapro should not be used during pregnancy unless absolutely necessary.
Lexapro may cause “non-teratogenic effects” in newborns. These effects are not birth defects, but they may include complications that require lengthened hospital stays, respiratory support, and the use of a feeding tube after delivery.
Serious effects in newborns noted with Lexapro may include:
- Respiratory distress
- Temperature instability
- Difficulty feeding
- Constant crying
Lexapro is linked to a number of birth defects. These include:
- Persistent Pulmonary Hypertension in Newborns (PPHN) – This prevents the infant’s lungs from circulating oxygen to the body and brain. This condition is fatal in 10% of infants.
- Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS) – Either the left or right side of the heart is severely underdeveloped. This condition is fatal without early intervention.
- Anencephaly – This is when the baby is born without part of the brain, skull, and scalp. This condition is usually fatal shortly after birth.
- Spina Bifida – The baby is born with an underdeveloped vertebra which leaves the spinal cord exposed. This condition requires surgery and has a fatality rate of 15% by age 4.
- Cleft Palate or Lip – The baby is born missing a portion of the roof of the mouth or upper front jaw. This may require surgery.
- Omphalocele – This is when the baby’s abdominal organs are on the outside of its body. This requires surgery, it is sometimes fatal.
- Scoliosis – The baby is born with a curved spine. This may require surgery.
- Club feet – This is when the baby’s feet curl inwards. This may require surgery.
- Autism Spectrum Disorder (ASD) or Delayed Development Disorder (DDD)
- Withdrawal symptoms or Serotonin Syndrome in infants
Because the medication is secreted in breast milk, mothers who are taking Lexapro should exercise caution. Their infants should be monitored for possible adverse reactions.
These possible adverse reactions include:
- Extreme drowsiness
- Decreased feedings
- Weight loss
Lexapro may increase the risk for suicide in patients who are depressed. Patients who are under 25 years of age, have bipolar disorder, or have a history of suicidal thoughts, are at an even greater risk. In 2004, the FDA began requiring that a “black box warning” be added to prescribing information for Lexapro which requires that information about the risk of suicide must be printed with a black border at the top of prescribing information for Lexapro.
Lexapro use may cause “serotonin syndrome” which occurs when too much serotonin builds up in the brain. It is more likely if it is taken with other medications that also affect serotonin including treatments for migraine, cough suppressants, and certain herbal remedies.
Serotonin syndrome may include symptoms such as:
- Unusually high fever
- Increased heart rate and changes in rhythm
- Loss of balance or coordination
- Confusion and hallucinations
In some cases, serotonin syndrome may be life-threatening. All medications should be discussed with a physician to avoid drug interactions.
Long-term use of Lexapro may lead to physical dependence in some patients. If the medication is suddenly stopped, it may cause withdrawal symptoms known as “SSRI discontinuation syndrome.”
Some of these symptoms of serotonin withdrawal may last for a long time and may include:
- Chills and shivers
- Brain “zaps”
- Electrical type skin sensations
Tapering off of Lexapro, rather than simply stopping, may reduce the chance of severe withdrawal effects but some symptoms may last for a long period of time.
Lexapro manufacturer Forest Laboratories and its parent company, Allergan, have faced multiple Lexapro lawsuits filed by patients or loved ones of those who took Lexapro and experienced serious injury, birth defects, or death. Forest has also faced a number of lawsuits for its sister drug, Celexa.
Many Lexapro lawsuits allege a lack of warning given to patients about the potential dangers of the medication. Research shows that the company may have been aware of the possibility of birth defects but chose to keep this information concealed from the public. Lawsuits filed against Forest for birth defects caused by Lexapro have stated that the women may not have taken the drug if they had been appropriately informed of the risks.
Mothers of children born with birth defects have filed numerous lawsuits against Forest Laboratories for the injuries as well as the failure to alert users of these potential risks. Three mothers in St. Louis, Missouri filed lawsuits arguing that, had they been aware of these potential side effects, they would not have taken the medication and would have chosen a safer alternative.
Forest Laboratories was found guilty of promoting Lexapro for use in children, even though it had not been approved for that purpose. The company paid a U.S. Department of Justice settlement of over $300 million and also agreed to settle a class action suit filed by people who claimed they were misled by inappropriate marketing.
Though Forest has faced hundreds of lawsuits for injuries caused by Lexapro and its sister drug, Celexa, most of these lawsuits have been settled, dismissed, or otherwise resolved. People or family members of those who were injured after taking Lexapro should seek legal advice.
There are two main types of lawsuits that have been filed regarding potential claims patients and their loved ones may have against the manufacturer of Lexapro.
These two lawsuit types are:
- Product liability
- Wrongful death
Both lawsuit types can result in monetary awards to the Plaintiff. They also help to raise awareness about dangerous products.
A medication manufacturer is charged with ensuring its medications are not unreasonably dangerous to patients and are safe for patients to take. Plaintiffs who have filed Lexapro lawsuits allege that the manufacturer did not provide adequate warnings about the possible severe risks of taking Lexapro. The plaintiffs argue that the injuries they or their loved ones sustained would not have resulted had they been properly warned about the risks associated with taking Lexapro.
A wrongful death lawsuit can be brought by certain immediate family members of a deceased person against the individual or company that caused the loved one’s death. Those family members or close loved ones who may sue vary depending on state laws. Wrongful death lawsuits have been brought against the manufacturer of Lexapro in situations where a baby died because of a birth defect linked to Lexapro and in situations where it is alleged that Lexapro led to suicide.
Choosing an attorney can be intimidating. It is important to find an attorney who is knowledgeable about the subject matter. Seeger Weiss, LLP specializes in cases involving Lexapro and will provide a free consultation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.