The U.S. Food and Drug Administration (FDA) had first issued a warning to healthcare professionals and patients about Paxil’s potential to cause birth defects among newborns whose mothers took the drug during their first trimester, in December 2005. Because the FDA had already approved Paxil for public consumption 12 years ago in 1993, the warning may have come a little too late. Paxil manufacturer The history of GlaxoSmithKline is littered with lawsuits and settlements. Another chapter of GSK’s entanglement with the law could be Paxil’s newly found side effects of birth defects.
Becoming one of the mostly prescribed drugs since its approval in 1993, Paxil or Paroxetine is an antidepressant which belongs to a group of medication known as selective serotonin reuptake inhibitors (SSRIs). First given the pregnancy category C classification by the FDA, it is not then surprising that the drug would be prescribed to some pregnant women who are prone to depression. Only 12 years after it was first approved for public consumption, the FDA issued a warning in 2005 and elevated the drug’s classification to pregnancy category D, which means there is human evidence of risk to infants, after medical studies have started linking Paxil to an increased risk of birth defects.
In the last 12 years, one could just imagine the number of pregnant women who were prescribed the drug and how many of them could have given birth to malformed newborns and never knowing their medication was responsible for it. The most common birth defect is a heart defect in the baby; however, premature births and a serious condition where there is not enough oxygen in the baby’s blood have also been reported by women who took Paxil during the first trimester of their pregnancy, according to the FDA. Women who took SSRIs during their third trimester were six times more likely to deliver babies born with persistent pulmonary hypertension (PPHN) than those who didn’t take SSRIs during their third trimester, based on a study by the New England Journal of Medicine.
It was also found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all based on a study from Sweden. Because of its potential to harm innocent newborns, the birth defects could be Paxil’s worst side effects, however, it is not the only side effect of the drug. The FDA had also issued a warning to healthcare professionals on reports of the occurrence of suicidal tendencies in clinical trials for various antidepressant drugs including Paxil in pediatric patients with major depressive disorder (MDD) in 2003. According to Bloomberg, Glaxo had to pay out more than $2 billion to resolve prior litigation over claims that Paxil caused suicides and withdrawal from the drug. Several Paxil lawsuits are continued to be filed in relation to its newly found birth defect side effects, this time around.