Are Opinions Changing Over the Potential for Lexapro Birth Defects?

Newark, NJIt will soon be a year since Michigan resident Chandra Shuck launched her Lexapro birth defects lawsuit against Forest Laboratories Inc. (Forest) and H. Lundbeck A/S (Lundbeck). It’s been a lot longer since Shuck held her infant daughter in her arms. The little girl died in the third week of April 2005 after enduring four open heart surgeries in an attempt to correct heart defects. The infant survived just two weeks.

Lexapro (escitalopram) is in a class of new-age antidepressants known as selective serotonin reuptake inhibitors (SSRI), a class that has been proven safe and effective for patients, if not for the offspring of women who continue to use SSRIs while pregnant. A growing debate in recent years has been whether or not it is prudent for a woman who suffers from depression to go off her SSRI while pregnant, or continue taking an SSRI such as Lexapro out of concern that untreated depression in the mother could, collectively, prove to be more harmful.

The latter has been described as the prevailing attitude amongst doctors. However, according to the New York Times (Wellness, 9/1/14)), a chorus of critics has begun to challenge such an assumption.

“If antidepressants made such a big difference, and women on them were eating better, sleeping better and taking better care of themselves, then one would expect to see better birth outcomes among the women who took medication than among similar women who did not,” said Barbara Mintzes, an associate professor at the University of British Columbia School of Population and Public Health, in comments to the New York Times. “What’s striking is that there’s no research evidence showing that.”

On the contrary, she said, “when you look for it, all you find are harms.”

There are plenty of studies that suggest a link between SSRI antidepressants such as Lexapro and birth and cognitive defects. One of the most recent studies, undertaken by researchers at Johns Hopkins University and released in April of this year, found that boys with autism were three times more likely to have been exposed to an SSRI antidepressant in the womb than male infants who had not been so exposed. However, the SSRI newborn birth defects that are cause for the most concern, and lay at the root of Shuck’s Lexapro lawsuit, are the links to congenital heart defects, including persistent pulmonary hypertension, or Lexapro pph. Several studies have found such an association.

Shuck’s Lexapro side effects lawsuit references these links to potential harms which, in her case, went from potential to reality and her daughter did not survive.

Shuck accuses Forest and Lundbeck of aggressively marketing Lexapro to women of childbearing age - including women who were actively pregnant - in spite of studies that suggested potential harms. The lawsuit also notes that approval of Lexapro by the US Food and Drug Administration (FDA) did not include use by pregnant women. Doctors have always possessed the ethical, moral and medical authority to prescribe drugs off-label (in other words, for uses not specifically approved by the FDA). However, Shuck asserts that Forest and Lundbeck were not forthcoming in noting the potential risk for newborn birth defects.

“Notwithstanding this knowledge…the defendants encouraged their sales force to promote Lexapro to women of child-bearing years and touted Lexapro as being a safe alternative for pregnant women,” Shuck says.

Shuck alleges violations to New Jersey’s Products Liability Act, Wrongful Death Act and Survivor’s Act.

The case is Chandra Shuck et al. v. Forest Laboratories Inc. et al., case number 1:14-cv-00114, in the US District Court for the District of New Jersey.