Paxil Birth Defects Caution Came A Little Too Late
The U.S. Food and Drug Administration (FDA) had first issued a warning to healthcare professionals and patients about Paxils potential to cause birth defects among newborns of mothers who 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. Lawsuits and settlements have become part of the history of GlaxoSmithKline (GSK), which manufactured Paxil. Another chapter of GSKs entanglement with the law could be Paxils 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). With some pregnant women prone to depression, it is not then surprising that the drug would be prescribed to them especially that it was first given the pregnancy category C classification by the FDA. Only 12 years after it was first approved for public consumption, the FDA issued a warning in 2005 and elevated the drugs 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.
One could just imagine the number of pregnant women who were prescribed the drug in the last 12 years 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 reported by women who took Paxil during the first trimester of their pregnancy is a heart defect in the baby; however, also reported are premature births and a serious condition where there is not enough oxygen in the baby's blood, according to the FDA. A New England Journal of Medicine study also found that 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.
According to a study from Sweden, birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all. The birth defects are not the only side effects of Paxil but it could be the worst because of its potential to harm innocent newborns. In 2003, 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). Glaxo had to pay out more than $2 billion to resolve prior litigation, according to Bloomberg, over claims that Paxil caused suicides and withdrawal from the drug. This time around, in relation to its newly found birth defect side effects, several Paxil lawsuits are continued to be filed.
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). With some pregnant women prone to depression, it is not then surprising that the drug would be prescribed to them especially that it was first given the pregnancy category C classification by the FDA. Only 12 years after it was first approved for public consumption, the FDA issued a warning in 2005 and elevated the drugs 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.
One could just imagine the number of pregnant women who were prescribed the drug in the last 12 years 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 reported by women who took Paxil during the first trimester of their pregnancy is a heart defect in the baby; however, also reported are premature births and a serious condition where there is not enough oxygen in the baby's blood, according to the FDA. A New England Journal of Medicine study also found that 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.
According to a study from Sweden, birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all. The birth defects are not the only side effects of Paxil but it could be the worst because of its potential to harm innocent newborns. In 2003, 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). Glaxo had to pay out more than $2 billion to resolve prior litigation, according to Bloomberg, over claims that Paxil caused suicides and withdrawal from the drug. This time around, in relation to its newly found birth defect side effects, several Paxil lawsuits are continued to be filed.
Source...