FDA Backtracking on PPHN Risks from Antidepressants
As if the dangerous side effects experienced by antidepressants (like Paxil) weren’t bad enough, the FDA has decided to backtrack on data that supported that fact. At one time, the FDA issued a warning that taking SSRI antidepressants like Paxil during pregnancy could cause babies to suffer from a rare heart and lung birth defect that is commonly referred to as persistent pulmonary hypertension in newborns (PPHN). But now the regulators are backtracking on that by claiming that conflicting studies have stymied the agency's ability to reach any real conclusions to that effect.
The announcement came down on December 14 in an SSRI drug safety communication, which concerned the labels for SSRI medications like Paxil, Zoloft, Prozac, Celexa and Lexapro. In the communication, the FDA said, “The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”
Due to this new opinion, the FDA is planning on updating warning labels on the link between SSRIs and PPHN to reflect this about face. The FDA also has explained to doctors that they have to use their own discretion in weighing the risks-to-benefits ratio when prescribing SSRIs to pregnant women.
This newfound opinion by the FDA seems like a serious backtracking for medical practitioners and patients alike. There are also many women who would sincerely disagree with the decision, namely those whose babies have been born with PPHN after they took SSRIs like Paxil while pregnant.
PPHN is a birth defect that causes newborns to have difficulty learning to breathe outside of the womb. The FDA's new position on PPHN and its connection to SSRIs is in stark contrast to its previous warnings, which most believe should still be in effect. Regardless of this decision, women and their families will continue to suffer and file lawsuits since there is ample studies to verify their claims that the drugs may be directly responsible for their babies’ afflictions.
