Paxil and Birth Defects
In 2005 the FDA announced that pregnant women who have taken the antidepressant Paxil during their first trimester have an increased chance of giving birth to a child with birth defects. The FDA cited 2 studies showing that the risks of birth defects, especially defects of the heart, were 1.5 to 2 times more likely in pregnant mothers using Paxil during the first three months of pregnancy.
Paxil, manufactured and marketed by GlaxoSmithKline (GSK) since 1992, is an antidepressant. Paxil is in a class of antidepressants known as SSRIs, or selective serotonin reuptake inhibitors. SSRIs change the balance of serotonin levels in the neurotransmitters of the brain to positively affect mood. Prior to 2005, Paxil was widely prescribed by doctors to their patients, including patients that planned to become pregnant or were pregnant. However, in 2005 the FDA required that GSK put a warning on the label of Paxil prescriptions reflecting the potential risk of birth defects. Now Paxil is a Category D drug. This means that studies have shown that Paxil may cause risks to a fetus.
Because GSK failed to warn users of Paxil and doctors who prescribed Paxil of the possibilities of birth defects, some in the medical and legal communities believe that there should be accountability on the part of GSK. You should contact an attorney if you or someone close to you took Paxil in their first trimester of pregnancy prior to 2005 and their baby was born with birth defects. Some of the medical problems linked to Paxil in newborns include:
- A hole in the atrial or ventricular septum
- Persistent pulmonary hypertension in the newborn (PPHN)
- Hypoplastic left heart syndrome (underdevelopment of the left ventricle of the heart)
- Coarctation (narrowing) of the aorta
- Omphalocele (abdominal defects)
- Craniosynostosis (misshapen head caused by the premature closing of the fetus’ skull)
- Hydrocephalus (water on the brain)
Please contact Brett H. Oppenheimer, PLLC a Kentucky attorney, who can help you to understand if you may be able to seek legal recourse for the injuries that your child has suffered. Call Brett at (502) 242-8877 for a free consultation.