Depression and Pregnancy Good Combo for Lexapro Sales

New York, NYThe maker of the popular antidepressant Lexapro lost millions in sales when the drug’s patent expired in early March of 2012. Lexapro brought in $13.8 billion for Forest Laboratories in just one decade - that’s a whole lot of depressed people, including pregnant women, some of whom gave birth to babies with birth defects.

While recent research shows that SSRI drugs, including Lexapro, have been linked to birth defects, health professionals continued to treat pregnant women with the drug.

How is this for a mixed message:

A: Lexapro is used to treat depression.
B: The onset of pregnancy can trigger depression.
C: Lexapro is often prescribed to pregnant women.
D: Lexapro is category C regarding pregnancy safety rating.*

If a pregnant woman takes Lexapro to treat depression and her baby is born with birth defects, would it be likely that she would suffer even greater depression? Lexapro is also linked to suicidal thoughts. However, some experts and even the FDA still say that, in some cases, Lexapro benefits outweigh the risks. Of course that would be the case if a pregnant woman can potentially do damage to herself and her unborn baby, but there are other effective treatments for depression besides SSRIs.

On its FDA Drug Safety website, the FDA says that “It is not known if Lexapro will harm your unborn baby” and to “Read the Medication Guide that comes with Lexapro before you start taking it and each time you get a refill. There may be new information.” It is a fact that a lot of people never read the medication guide and chances are, a pregnant woman who is severely depressed won’t read it either.

The jury still seems to be out on the SSRI link to birth defects. In a study published in Human Reproduction (October 31, 2012), author of the study Dr. Adam Urato, chairman of obstetrics and gynecology at MetroWest Medical Center and a maternal-fetal medicine specialist at Tufts Medical Center, said the following in a press release:

“There is clear and concerning evidence of risk with the use of the SSRI antidepressants by pregnant women, evidence that these drugs lead to worsened pregnancy outcomes. Second, there is no evidence of benefit, no evidence that these drugs lead to better outcomes for moms and babies. And third, we feel strongly that patients, obstetrical providers, and the public need to be fully aware of this information.”

Forest was ordered in 2010 to pay $313 in fines after pleading guilty to federal charges of illegally promoting Lexapro, a drop in the bucket considering those billions of dollars in Lexapro sales. Legal analysts predict that the number of lawsuits filed by women who allege their children suffered birth defects as a result of them taking Lexapro during pregnancy will put a bigger dent in Forest’s pot. They say that the Lexapro settlement amount will exceed $1 million for each affected family.


*Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. BUT human data indicate risk in the 3rd trimester.