First released in 2005, two FDA public health advisories have been issued involving Paxil, an SSRI antidepressant. The warning indicated that women taking paroxetine – the brand name of which is Paxil – during the first trimester of their pregnancy may have exposed their babies to the risk of developing serious congenital malformations, most especially one involving the heart. The second advisory that came out in 2006 warned patients and healthcare professionals on the potential risk of chronic pulmonary hypertension to the newborn. Such risk is persistent among infants whose mothers have taken Paxil within or after the twentieth week of conception.
As a backgrounder, the antidepressant drug, Paxil, is currently manufactured by pharmaceutical company, GlaxoSmithKline. Paxil is classified under SSRI, or selective serotonin reuptake inhibitors. Drugs under this categorization work by restoring the balance of serotonin in the brain, a chemical that acts as neurotransmitter affecting a person’s mood. As such, Paxil effectively relieves depression and improves some disorders affecting the mood of a patient. Originally approved by the FDA in 1992, Paxil is used in the treatment of major depression. In 1996, the FDA further included other indications such as major obsessive-compulsive disorder and panic disorder. It also added, in 1999, indication for social anxiety disorder; in 2000, indication for post-traumatic stress disorder; and, lastly adding in 2001, indication for generalized anxiety disorder.
After its review of two unpublished 2005 epidemiology studies, the FDA elevated the pregnancy category of Paxil from C to D. The category is the second most dangerous drug category available. Note that category D is earmarked for drugs which positive human evidence show may cause serious harm to a fetus when taken by a woman under pregnancy. The first study showed how women who took Paxil in early pregnancy could be exposed to increased risk of giving birth to an infant with a heart problem. On the other hand, the second study indicated that infants born to women under Paxil therapy on the first trimester of their pregnancy have a 1.5-fold increased risk for heart defects, and a 1.8-fold increased risk for congenital birth defects.
The American Journal of Nursing released a study by researchers who sought to examine the potential adverse side effects of fetal exposure to SSRIs like Paxil during pregnancy. Results of the study showed that the birth defects associated with Paxil include PPHN, neural tube birth defects, heart defects, cleft lip, cleft palate, limb defects, anal atresia, omphalocele, and craniosynostosis.
Because of these potential Paxil birth defects, women who are pregnant or planning to become pregnant are advised to immediately consult their physician, as it is never advisable to discontinue the use of a prescription medication without medical approval. Doing so may cause unprecedented harm to the mother as well as to her child. However, with a doctor’s help, a mother may be given a chance to find a safer alternative to Paxil.
Every child deserves a happy and healthy life. But infants with a birth defect, life can be unreasonably difficult. When a dangerous drug such as Paxil brings such defect, a lawyer is necessary to determine the extent of compensation for both mother and child. Paxil lawyers are a significant resource in every birth defect case. With their expertise, Paxil lawyers can easily access documents and testimonies of medical and scientific experts who are key to establishing a strong case.
If you or if you know somebody who took Paxil under pregnancy, and/or your baby was born with a major birth defect, you need to contact an experienced Paxil lawyer for defense. Know that your child’s life-long care or financial compensation for his or her injuries and medical expenses are at stake.