Birth Defect Lawsuits
Epilepsy and Migraine drug- Topamax
The Food and Drug Administration has re-categorized Topamax to Pregnancy Class D. This indicates that the drug poses a significant risk to a growing fetus and that there is data to indicate birth defects in humans. Topamax was previously classified as a Class C drug. (See classifications below)
A study by the American Antiepileptic Drug Pregnancy Registry indicates that mothers taking Topamax during the first trimester of pregnancy were 21 times more likely to give birth to a child with cleft lip and/or palate than women who did not take the drug.
The FDA notified the medical community and the public on May 4, 2011 that there is an increased risk for development of cleft lip and/or cleft palate in infants born to women who took Topamax during the first trimester of their pregnancy. The FDA recommends that women of childbearing age find treatment options other than Topamax and use effective birth control.
If you would like additional information regarding Topamax please contact us at 622-3344.
SSRIs- Paxil, Lexapro, Celexa, Fluvoxamine, Symbyax, Zoloft
Antidepressants known as selective serotonin reuptake inhibitors (SSRIs) have been shown to increase the risk for birth defects when taken by the mother during early pregnancy.
In 2005 the Food and Drug Administration issued a warning of a possible link between Paxil and birth defects. At that time Paxil was re classified as a Category D drug rather than a Category C drug. (See classifications below) Currently no other SSRI antidepressants are classified as Category D drugs, however a recent study published in the New England Journal of Medicine indicated that women using antidepressants during pregnancy and their newborns have increased pathology, thereby putting the classification of all SSRIs into question.
The congenital abnormalities linked to use of SSRIs include:
- Heart defects
- Persistent pulmonary hypertension (PPHN)
- Anal atresia (a malformation of the anus)
- Omphalocele (an abdominal defect)
- Craniosynostosis (a skull defect)
- Club foot and other limb malformations
- Spina bifida (a neural tube defect)
If you would like additional information regarding SSRIs, please contact us at 622-3344.
FDA PREGNANCY CATEGORIES
The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows:
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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