After the Food and Drug Administration (FDA) approved Paxil for sale in the United States in 1992, it was categorized as safe for women to take during pregnancy. However, after years of reports of birth defects and congenital malformations, the FDA changed that classification to a Category D, a level that covers all harmful drugs that “have demonstrated a risk to the fetus.” Many women who took Paxil during their pregnancy and lost their babies to severe birth defects are now questioning what role their so-called “safe” medication played in the death of their infants.

Another woman taking the drug also did not immediately make the connection. In this instance, ultrasound technicians discovered that her baby had no heartbeat at five months of pregnancy. Doctors had to induce the birth of her stillborn child. Years later she too heard about that in fact Paxil can increase the risk of birth defects, particularly heart problems.

In the face of growing evidence, the FDA finally confirmed the connection between Paxil and birth defects on December 8, 2005. The FDA Public Health Advisory released that day states that women taking Paxil in the first three months of pregnancy could experience up to twice the risk of birth defects, even over those taking another type of antidepressant. Although this still represents a slight risk, it is obvious that if there are other treatments than Paxil available, they should be used instead.

So why did it take 12 years to find out that Paxil could cause birth defects in general, and heart defects in particular? The structure of drug testing and approval in the United States is set up in such a way so that it is easier for drug companies to get their drugs to market. This obviously means that the pharmaceutical companies start bringing in profits faster, and ostensibly that patients can benefit from the drugs sooner.

However, getting to market faster usually means less testing, both in terms of the number of research trials and the amount of information they look for. And, due to several different circumstances, research data can be discarded, hidden, or manipulated to show the drug in the absolute best light. All in all, it is certainly “buyer beware” when it comes to the nation’s drug supply.

You have the right to expect a safe product and to have had all the risks explained to you. If your child was born with severe birth defects and you were taking Paxil during your pregnancy, contact Jim S. Adler & Associates for expert medical legal advice. We may be able to help you secure compensation for excess medical bills, lost wages and your pain and suffering. To find out if you may be entitled to a fair settlement, call Jim S. Adler & Associates today or fill in the form on this page with the details of your Paxil experience and birth defects for a free case review.

Jim S. Adler & Associates has additional offices and attorneys at City Place Building, 2711 North Haskell Ave., Suite 2100 LB40, Dallas, Texas 75204-2887; Bank of America, 12605 East Freeway, Suite 400, Houston, Texas 77015-5619 (serving Channelview, Texas); and San Pedro Plaza, 7330 San Pedro Ave., Suite 700, San Antonio, Texas 78216-6237.