FDA Approves Generic Lexapro Despite Lexapro Side Effects and Lexapro Lawsuits

FDA Approves Generic Lexapro Despite Lexapro Side Effects and Lexapro Lawsuits

Lexapro is regularly being seen in courtrooms across the country as the basis for serious personal injury claims involving children being born with birth defects – their entire lives impacted by this drug – because, the plaintiffs argue, taking Lexapro during pregnancy under a doctor’s prescription to combat depression has permanently injured the unborn child.

Across the country, mothers who trusted their health care providers and the nation’s drug companies are giving birth to babies suffering from birth defects like:

  • spina bifidathe backbone and spinal canal do not close before birth;
  • cleft lip and palette – during the early stages of pregnancy, the baby’s roof of the mouth does not join in the normal way. The lip is sometimes cleft as well as the palate; and
  • club foot – foot turns inward and downward at birth, and is difficult to place in the correct position. The calf muscle and foot may be slightly smaller than normal.

Meanwhile, one company is making news on Wall Street because it’s putting its generic version of Lexapro out in the marketplace (read that as competition for the Lexapro meds out there already) and Forest-Janssen, the company that gave us Lexapro in the first place may get hurt by the generic competition because Lexapro has been its big moneymaker.

Meanwhile, what is the Food and Drug Administration doing about Lexapro and these babies?  The FDA has okayed spreading Lexapro even further through our country by giving a big thumbs up to the generic version being marketed here.  From the Food and Drug Administration:


For Immediate Release: March 14, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first generic Lexapro to treat depression and anxiety disorder

The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.

Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.

People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can’t relax, startle easily, and have difficulty concentrating.

“These psychiatric conditions can be disabling and prevent a person from doing every-day activities,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options.”

Teva Pharmaceutical Industries/IVAX Pharmaceuticals gained FDA approval to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths.

In the clinical trials for Lexapro, the most commonly observed adverse reactions were: sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and low sex drive (decreased libido).

Escitalopram and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period. Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic escitalopram can be obtained from Teva.

Bottom line: Don’t trust drugs as being safe just because a doctor says they’re just the thing for you!  Drugs are simply products sold for profit in this country. Be careful.  And, if you or a loved one has been harmed by Lexapro or another dangerous drug, contact an experienced personal injury attorney and learn if a law firm with know how with dangerous drug law suits may be able to help you with claims against the drug manufacturers, your doctors, or others who may be responsible for harm to your baby.  No, you cannot sue the FDA.

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