Can Antidepressants Cause Birth Defects?

Antidepressants are once again in the news. A number of lawsuits have been filed against Forest Labs, maker of Lexapro, by mothers of babies born with birth defects. Class action lawsuits against GlaxoSmithKline, manufacturer of Paxil, have won consumers awards of billions of dollars in compensation. It has been proven both companies were aware of the dangers their products posed, but concealed the information.

The danger posed by Lexapro is well documented. The drug contains chemicals that travel through the placenta, creating the risk of serious complications and even death, for both mothers and their unborn babies. During the Paxil lawsuit, a long list of life-endangering and debilitating side effects was reported. Paxil is twice as likely as other antidepressants to cause birth defects, and some babies have been born with a dependency on Paxil.

Birth defects attributed to both drugs include:

Septal heart defects
Pulmonary hypertension of newborn (PPHN)
Anencephaly, a fatal neural tube disorder
Underdeveloped or missing parts of skull
Spina bifida
Pulmonary stenosis
Pulmonary atresia
Cleft lip or cleft palate
Autism Spectrum Disorder (ASD)
Scoliosis
Malformed limbs

Prosecutors also allege GlaxoSmithKline is guilty of illegal promotion of Paxil. The company has advertised it as “safe and effective” in children. In fact, Paxil had not been approved by the U.S. Food and Drug Administration (FDA) for use in patients under the age of 18.

The FDA also gave Lexapro a grade C for its level of safety when used during pregnancy. The rating was based on negative effects on reproduction during animal testing.

A key factor in the lawsuits in the Lexapro cases is the fact the company failed to issue a warning regarding the potential of birth defects. Although the FDA advises physicians to carefully review options with their patients before prescribing antidepressants, it is clear that Forest Laboratories concealed critical information from doctors and patients.

GlaxoSmithKline has now set aside more than $3 billion to settle court cases. Hundreds of new lawsuits against Paxil are emerging. More than 40 drug regulatory agencies in seven countries have issued warnings on the harmful effects of Paxil.