FDA to Evaluate the Risk of SSRI Birth Defects

Sacramento, CAIn early February the Food and Drug Administration (FDA) announced that it would review a lengthy list of drugs for potential safety problems. Selective Serotonin Receptor Antagonist (SSRI) antidepressants are on that list. Specifically, the agency said they would be evaluating the risk of SSRI birth defects.

SSRIs are widely used in the US and many women who become pregnant while taking an antidepressant are advised by their physicians to remain on their medication. Some reports even indicate that the benefits of staying on medication outweigh the risks associated with untreated depression and post partum depression. There are likely many women who would disagree with this advice.

Sarah is one of those women. Sarah took Paxil while she was pregnant, and she believes her son is paying the price.

Sarah remembers that her son began throwing up from the minute he was born. The doctors told her that was normal, but that didn't explain why her newborn son appeared to have a pinched esophagus tube. He underwent many x-rays to try and determine what was wrong, but Sarah was never provided with an adequate explanation.

When she brought her son home she remembers that he would cry a lot, because he had stomach cramps and she wondered if this was normal. She suspected that given his medical history so far, it probably wasn't. She never did find out.

Now, Sarah's son is 6 and he is very hyper. He has difficulty sitting still, focusing. Could the SSRI she took while she was pregnant have impacted her son's health? The trouble is she doesn't know.

The FDA has listed SSRIs and birth defects as an area of concern; does that mean answers could be forthcoming? Not necessarily. The agency cautioned that it had not drawn any conclusions in drawing up the list and said that "The appearance of a drug on this list does not mean that the FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk."

What is Known So Far About SSRI Birth Defects
In 2005 the FDA issued a public health warning regarding Paxil, based on findings from 2 studies which showed an increased risk for birth defects in babies born to women taking the drug during pregnancy. In conjunction with the warning, the FDA placed Paxil in its second highest category of drugs known to cause birth defects. In a later warning, the FDA said that Paxil, "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."

Paxil was approved as an antidepressant in 1993 and is among the most heavily prescribed antidepressants on the market. But there are other well known SSRIs, such as Eli Lilly and Co's Prozac, Pfizer Inc's Zoloft, and Forest Laboratories Inc's Lexapro and Celexa.

In November 2008 a study published in the British Journal of Clinical Pharmacology reported a 3 times greater risk for heart defects in babies born to mothers taking either Prozac (fluoxetine) or Paxil. The study looked at babies born to 800 women who said they took either drug during the first trimesters of their pregnancies.

These are the medical studies, the clinical data that exist to prove there is a very strong likelihood of cause and effect associated with prenatal exposure to SSRIs. However, there are many women in the US with stories like Sarah's--of children born with health problems for which there were no apparent risk factors, or that are hard to diagnose. Worse, many children have problems that continue on through childhood. One wonders if the FDA has any plans to try to evaluate these issues in the context of prenatal SSRI exposure. And if so, how long will it take for Sarah and hundreds of mothers like her to get some answers?