Serious concerns have been raised about the safety of the antidepressant Paxil, due to research suggesting GlaxoSmithKline’s drug may be linked to serious birth defects like persistent pulmonary hypertension of the newborn (PPHN). Paxil (paroxetine) was initially approved by the FDA in 1992 as a treatment for major depressive disorder, and has since been additionally …
Serious concerns have been raised about the safety of the antidepressant Paxil, due to research suggesting GlaxoSmithKline’s drug may be linked to serious birth defects like persistent pulmonary hypertension of the newborn (PPHN). Paxil (paroxetine) was initially approved by the FDA in 1992 as a treatment for major depressive disorder, and has since been additionally indicated to treat conditions like social anxiety disorder, obsessive-compulsive disorder, major panic disorder, post-traumatic stress disorder, and generalized anxiety disorder. Paxil is manufactured by drug firm GlaxoSmithKline, and belongs to a class of antidepressants called SSRIs, or selective serotonin reuptake inhibitors.
Paxil Elevated to Pregnancy Category D
According to a public health advisory issued by the FDA in 2005, exposure to Paxil in the first trimester of pregnancy may increase a child’s risk of being born with birth defects, particularly heart malformations. The FDA warning was influenced by two unpublished epidemiological studies – one found a 2-fold increased risk of heart defects among children exposed to Paxil in pregnancy compared to the entire Swedish national registry population, and one found a 1.5-fold increased risk of the same, compared to children exposed to other antidepressants in utero. It was this discovery that prompted the FDA to elevate the pregnancy category of Paxil from C to D.
Pregnancy Risks Associated With Paxil
In 2006, the FDA issued a second advisory, this time warning patients about the pregnancy risks associated with SSRI antidepressants as a whole. According to the FDA notice, which came on the heels of a New England Journal of Medicine study published that same year, women who take SSRI antidepressants like Paxil after the twentieth week of pregnancy may have a six-times increased risk of giving birth to children with the birth defect PPHN. PPHN is a life-threatening heart and lung defect in which a baby’s circulation continues to bypass the lungs after birth, depriving the rest of the body of the oxygen it needs to survive.
Legal Help for Birth Defect Victims
In light of the alleged risk of PPHN birth defects in children exposed to Paxil in pregnancy, the FDA has advised patients and physicians to carefully consider the possible benefits and potential risks associated with the antidepressant drug before beginning or continuing Paxil treatment. Paxil patients should also be aware that the antidepressant may increase a child’s risk of being born with birth defects like cleft lip, neural tube defects, heart defects, cleft palate, and other malformations. The pregnancy risks linked to Paxil may outweigh the benefits for some pregnant patients, in which case a safer alternative to Paxil may be a better treatment option. For those who have suffered from birth defects like PPHN possibly linked to Paxil use, contact a Paxil attorney for legal help.