Zoloft® Side Effects Prompt FDA to Request Warning Label Changes
Warning labels on prescription medications educate consumers about risks a drug may pose. The problem is, many drug side effects aren’t discovered until after many consumers have been exposed to them.
Recently, a controversy erupted over allegations that warning labels on the antidepressant, Zoloft®, failed to inform female patients of the risk of congenital heart defects in children if the medication is taken during pregnancy.
Several Zoloft side effects studies showed that taking the drug while pregnant can lead to an increased risk of birth defects, such as persistent pulmonary hypertension or omphalocele.
The makers of Zoloft have maintained the drug is safe for pregnant women despite the findings.
An article from Bloomberg Business says the U.S. Food and Drug Administration has asked Pfizer, Inc., the drug’s manufacturer, to change the warning labels to address the risk of birth defects.