Product News and Recalls

FDA to Implement New Drug Safety Labeling System for Pregnant Women

FDA to issue new warnings on drug birth defectsThe U.S. Food and Drug Administration (FDA) has announced it will switch to a new drug safety labeling system that will provide more information to pregnant women and their doctors, the Chicago Tribune report. According to the article, this revision to prescription guidelines will be the first since 1979.

The new drug safety labeling system will replace the current A–X grading scheme and provide more detailed information on dosages and health risks during pregnancy, breastfeeding, and potential effects on fertility.

According to the FDA, the new system is intended to address the fact that many mothers-to-be take at least one prescription drug during pregnancy for serious conditions like diabetes and depression. Simply suspending treatment could prove more detrimental to women and newborns than continuing to use medications through pregnancy. The new standards for drug labeling will better allow patients and doctors to weigh the benefits and risks of using prescription drugs during pregnancy and breast-feeding.

For example, Zofran, an antiemetic intended to treat nausea and vomiting in chemotherapy, radiation therapy, and surgery patients, has been linked in studies to increased chances of birth defects. Zofran is frequently prescribed to pregnant women for the off-label use of treating morning sickness. However, a 2012 study found that pregnant women who used Zofran during their first trimester were twice as likely to give birth to a child with congenital defects. Another study from 2014 also suggested Zofran may double the chance of giving birth to a child with a cleft palate or other health defect. Plaintiffs in Zofran lawsuits have accused the drug’s manufacturer, GlaxoSmithKline, of marketing Zofran to pregnant women while hiding information about the increased risk of birth defects the drug may pose. They claim that the pregnancy category letter was inaccurate and inadequate to disclose the known risks of Zofran.

Another drug linked in research to birth defects is Pfizer’s Zoloft. Zoloft belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs are often prescribed to help treat depression, anxiety, bulimia, and obsessive-compulsive behavior. Unfortunately, multiple studies have linked Zoloft and other SSRIs to serious heart and lung birth defects in children. One study reported that women who took a certain SSRI during their first trimester of pregnancy were two times more likely to give birth to children with heart defects. In another study, researchers concluded that children whose mothers took an SSRI like Zoloft during the first three months of pregnancy had a 50 percent increased risk of developing a heart defect. In 2012, a judicial panel consolidated Zoloft birth defect lawsuits filed against Pfizer in the federal court for the Eastern District of Pennsylvania. Since then, the number of Zoloft lawsuits has continued to grow.

Always be sure to check with your doctor or physician before changing medications. If you or a loved one experienced birth defects or injury after taking Zofran, Zoloft, or another medication while pregnant, contact the birth defect and injury lawyers at Lopez McHugh today. Through a free legal consultation, we can help determine whether a birth defect or injury lawsuit is right for you.