Do Not Use Until October 2005 Escitalopram (LEXAPRO) – The Sixth Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant

Escitalopram (LEXAPRO) was approved by the Food and Drug Administration (FDA) in August 2002 and brings to six the number of selective serotonin reuptake inhibitor (SSRI) antidepressants now on the market in the U.S. The other SSRIs currently available are citalopram (CELEXA), fluoxetine (PROZAC, SERAFEM), fluvoxamine (LUVOX), paroxetine (PAXIL), and sertraline (ZOLOFT).

Both escitalopram and citalopram are produced by Forest Laboratories, Inc. of New Jersey. We listed citalopram as a DO NOT USE FOR SEVEN YEARS drug (until October 2005) in the Companion to the 1999 edition of Worst Pills, Best Pills. Our Seven Year Rule is based on research published in the May 1, 2002 Journal of the American Medical Association showing that half of all new drug withdrawals for safety reasons or warnings about serious adverse drug reactions occur within a drug’s first seven years on the market (see Worst Pills, Best Pills News article June 2002). We have also listed escitalopram as DO NOT USE UNTIL OCTOBER 2005 because for practical purposes it is the same drug as citalopram and it has no therapeutic or safety advantage over citalopram or other SSRI antidepressants.

The primary purpose for developing escitalopram appears to be nothing more than a strategy to protect sales as citalopram nears the end of its patent protection. In the long run, escitalopram will cause economic harm to individuals and the healthcare system.

Many drugs exist in two forms that are chemically identical but mirror images of each other called isomers or enantiomers. Citalopram is such a drug and escitalopram is simply one of citalopram’s two isomers. There was nothing intellectually challenging or creative in developing escitalopram and clearly the new monopoly granted to this drug is an abuse of the intent of our patent laws.

Escitalopram is approved for the treatment of major depression. A major depressive episode implies a prominent and relatively persistent, nearly every day for at least two weeks, depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The other SSRIs are approved for various conditions such as bulimia, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and premenstrual dysphoric disorder.

Escitalopram, and other SSRIs, must not be used together or within 14 days of stopping the family of antidepressants known as monoamine oxidase inhibitors (MAOIs). The MAOIs include drugs such as isocarboxazid (MARPLAN), phenelzine (NARDIL), and tranylcypromine (PARNATE). Because this drug interaction is potentially fatal the approved product labeling, or “package insert,” for escitalopram carries the following warning in bold letters:

“The use of alcohol by patients taking escitalopram is not recommended. Escitalopram affects the central nervous system (CNS) and caution should be exercised when the drug is used with other drugs that either stimulate or depress the CNS.”

The unregulated herbal dietary supplement St. John’s Wort can interact with the SSRIs. The use of these drugs with St. John’s Wort can lead to an increased incidence of adverse drug reactions. The use of St. John’s Wort should be stopped.

There have been adverse reaction reports describing patients with weakness, exaggerated reflexes (hyperreflexia), and uncoordination when SSRIs are used together with the migraine drug sumatriptan (IMETREX). The use of citalopram in combination with the antifungal drug ketoconazole (NIZORAL) can result in a significant decrease in levels of ketoconazole. The same interaction may result when escitalopram is administered with ketoconazole. When escitalopram was administered in combination with the high blood pressure lowering drug metoprolol (TOPROL, TOPROL XL) there was a significant increase in the blood levels of metoprolol even though no clinically significant effects on blood pressure or heart rate were seen.

Escitalopram was found to activate mania-hypomania in one patient (0.1%) of 715 patients treated with the drug and in none of 592 patients treated with a placebo. Activation of mania-hypomania has also been reported in patients treated with citalopram and the other marketed SSRIs.

Escitalopram is similar to the other SSRIs in that nausea, diarrhea, drug mouth, insomnia, dizziness, increased sweating and fatigue have occurred with its use. Sexual adverse effects in clinical trials with escitalopram were reported in less than five percent of patients, except for ejaculatory disorder (mainly delay), that occurred in nine percent of men.

The editors of the internationally respected Medical Letter On Drugs and Therapeutics concluded in their September 30, 2002 review of the drug that “Escitalopram (LEXAPRO), the active enantiomer of citalopram (CELEXA), is effective for treatment of depression, but it has not been shown to be more effective, more rapid-acting or less likely to cause adverse effects, including sexual dysfunction, than citalopram or any other SSRI.”

We agree.

What You Can Do

You should wait until at least October 2005 before using escitalopram.