Pharmaceutical

BMJ confirms FDA’s warning that SSRIs can cause birth defects

In January, the British Medical Journal reaffirmed a U.S. Food and Drug Administration (FDA) warning when it published a study that showed a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), were linked to serious birth defects in newborns when taken by the mothers while they were pregnant. SSRIs include the brand names Paxil, Zoloft, Celexa, Lexapro and Prozac, and the birth defects associated with these pills include heart defects, lung conditions, brain and spine defects, skull deformities, club foot, and abdominal defects.

That study followed warnings from several institutions and medical publications such as the New England Journal of Medicine, Boston University, University of California at San Diego, National Birth Defects Prevention Society of Infants, University of Ulm, and Aarhus University in Denmark.

SSRIs are among the most prescribed medication in the country and were considered safe to use during pregnancy because there was no data available to show how the drug affected developing fetuses. Yet, drug companies, such as GlaxoSmithKline (GSK), makers of Paxil, were slowly beginning to gather data from people who were using their drugs, but, lawsuits later claimed, the drug companies opted to protect their profits and not to go public with the data.

It wasn’t until an outside study  was conducted on Paxil that researchers noticed a frightening trend – that use of the SSRI during pregnancy was linked in particular to a life threatening lung condition known as persistent pulmonary hypertension (PPHN). The FDA warned doctors not to prescribe the drug to pregnant women unless the benefits outweighed the serious risks to fetuses.

Since then, GSK has paid out nearly $1 billion to resolve about 800 cases over claims of birth defects. The average payout per lawsuit was $1.2 million. Now maker of other SSRIs are facing the same type of lawsuits from women who claim that using the drugs during pregnancy caused their babies to be born with serious birth defects.

PAXIL and PAXIL CR are registered trademarks of GlaxoSmithKline. ZOLOFT is a registered trademark of Pfizer Inc. Celexa® is a registered trademark of Forest Labs. Lexapro® is a registered trademark of Forest Labs. PROZAC®is a registered trademark of Eli Lily and Company.

Source: eYugoslavia