Lexapro was approved in 2002. The manufacturer, Forest Laboratories has been fined more than $300 million for illegal marketing of Lexapro and two other medications and is facing multiple lawsuits regarding the use of the medication.
Lexapro (escitalopram) is a “next-generation” of the antidepressant citalopram, sold as Celexa. It is one of the newer members of the serotonin-specific reuptake inhibitors (SSRIs) class of anti-depressants which were designed to have fewer side effects than the traditional, older medications used for depression.
Lexapro is approved for the use in the treatment of major depressive disorder in both adults and adolescents. It is also used for the treatment of generalized anxiety disorder in adults and has been prescribed to millions of patients worldwide.
In 2004, the FDA began requiring that Lexapro and other SSRI type anti-depressants carry a “black-box” warning regarding the increased risk of suicide, particularly in young patients (children, adolescents and young adults). A black-box warning is the most severe warning that any medication can have and is placed at the top of all prescribing information for the medication.
The FDA also required additional warnings in 2006 regarding the possibility of birth defects in women who took Lexapro while pregnant. Despite warnings, sales of the medication exceeded $350 million in 2011, before it became available as a generic medication.
The manufacturer of Lexapro continues to face a number of lawsuits regarding birth defects and suicide risks.
What is Lexapro
Lexapro (escitalopram) is a newer member of the serotonin-specific reuptake inhibitor (SSRI) type of anti-depressants. Lexapro is approved to treat generalized anxiety disorder in adults and major depressive disorder in adults and adolescents.
It may also be used as off-label treatment for bipolar disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder (PTSD) and social anxiety disorder. Physicians may prescribe medications for off-label uses; however manufacturers may not advertise medications for uses that have not been approved by the FDA.
The SSRIs group of antidepressants target serotonin receptors in mood centers of the brain. Serotonin, a neurotransmitter (chemical messenger) helps to increase the mood level and may have a calming effect. It also may help promote sleep due to a tryptophan like effect.
When serotonin is released by a nerve cell in the brain, it interacts with a serotonin receptor which then sends a signal to the next cell. The serotonin is then gathered up to be reused at a later time. SSRIs work by blocking the “reuptake” of serotonin so that more signals are sent and the mood increases.
Most health practitioners warn that anti-depressants usually do not take full effect for two or three weeks after starting them.
Lexapro is available in 5 mg, 10 mg, and 20 mg tablets. It is also available in an oral solution. Escitalopram has been available generically since 2012.
Side Effects and Drug Interactions of Lexapro
Like most medications, Lexapro has a number of side effects. These side effects, similar to other SSRIs, are due to its involvement with serotonin. Lexapro may also interact with other medications that are taken. Most of the time, side effects are mild but in some cases effects may be more severe and even life-threatening.
Common side effects of Lexapro include:
- Weight changes
- Dry mouth
- Sexual dysfunction in both males and females
Lexapro can also have drug interactions with other medications including:
- Antianxiety agents , pain relievers and muscle relaxants(increased sedation)
- Dextromethorphan (increases chance of serotonin like reaction)
- Blood thinners such as warfarin and aspirin (may increase bleeding risk)
- Diuretics such as furosemide and hydrochlorothiazide (lowers sodium levels)
- Antihistamines such as diphenhydramine or chlorpheniramine (increased sedation)
- Other antidepressants (increased side effects)
- Appetite suppressants such as phentermine (nervousness, heartbeat irregularities and more severe effects)
- Caffeine and ergot combinations (serotonin syndrome – seizures, heart rate and blood pressure changes, fever and more severe effects)
Serious Adverse Events of Lexapro
Lexapro in Pregnancy
Like other SSRIs, Lexapro is now a “Category C” medication and may cause complications for women who are pregnant and their fetus. If taken by pregnant women, Lexapro may cause:
- Miscarriage or premature birth
- Persistent Pulmonary Hypertension in Newborn (PPHN), fatal in 10% of infants
- Heart defects such as Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS)
- Cranial defects such as anencephaly, spina bifida, cleft palate or lip
- Malformation of bones such as Scoliosis, Club Feet or other limb disorders
- Developmental disorders such as Autism Spectrum Disorder or Delayed Development Disorder
- Withdrawal symptoms in infants
Medical organizations such as ACOG (American College of Obstetrics and Gynecology) warn that SSRIs should be avoided in women who are or are planning on becoming pregnant unless potential benefits clearly outweigh the risks.
Lexapro and Suicide
In 2004, a black box warning regarding the increased risk of suicide in children, adolescents and young adults was required to be added to all prescribing information for SSRI anti-depressant medications. The FDA requires black box warnings to be placed at the top of prescribing information when a serious risk of danger exists but the benefits may outweigh risks of taking a medication. Black box warnings are printed at the top of prescribing information in a “black box” so that the information will be readily seen by practitioners.
All patients who take Lexapro should be closely monitored for symptoms indicating suicidal behavior, particularly when first beginning the medication.
Lexapro and other serotonin specific anti-depressants may cause “serotonin syndrome”. Serotonin syndrome effects can be severe and may warrant emergency treatment. The risk of developing serotonin syndrome is increased when certain medications such as dextromethorphan, meperidine and ergotamine medications. Herbal and nutritional supplements such as 5HT, tryptophan, and St. Johns Wort may also increase the risk.
Zoloft may cause side effects from a condition called “serotonin syndrome” these effects are more severe and may require emergency medical treatment. The risk of the development of serotonin syndrome may be increased with certain medications including dextromethorphan, meperidine, ergotamine and derivatives, and herbal supplements such as St. Johns Wort and tryptophan.
Symptoms of Serotonin Syndrome include:
- Increased heart rate and changes in rhythm
- Loss of balance or coordination
- Seizures or loss of consciousness
Though rare, taking an SSRI for a long period of time may lead to dependence. This is different than addiction but may cause significant withdrawal effects, known as SSRI discontinuation syndrome. Symptoms of Lexapro withdrawal may include:
Many physicians recommend that Lexapro be tapered when the medication is discontinued to avoid severe withdrawal effects. Some patients may experience additional effects that may continue for a long period of time after Lexapro have been described as:
- Brain zaps
- Brain shivers
- Electrical type skin sensations
Improper Marketing of Lexapro
In 2009, the US Department of Justice accused Forest Labs of improper marketing. The company was accused of promoting the medication for unapproved uses, failure to disclose negative trial results and of paying kickbacks to physicians for prescribing the medication. A document released by the US Senate Special Committee on Aging showed that Forest had included methods for physician compensation for the prescribing of Lexapro in marketing plans developed before the drug’s approval in 2002.
In 2010, Forest Pharmaceuticals, the subsidiary of Forest Labs, agreed to pay more than $313 million in fines to settle charges related to the marketing of Lexapro and two other medications manufactured by the company.
The first lawsuits regarding Lexapro were filed in 2012 by three mothers who had taken the medication during pregnancy. Attorneys for the plaintiffs claim that the manufacturers were aware of the increased risk of birth defects and continued to market the medication without adequate warning. They also allege that full disclosure was not provided regarding clinical study results and that the company continues in its failure to alert the public. The lawsuits claiming birth defects of spina bifida, club foot and cleft lip/palate have been filed in St. Louis Circuit Court.
Additional lawsuits are expected.