Epilepsy and Migraine drug- Topamax
The Food and Drug Administration has re-categorized Topamax to Pregnancy Category D to Pregnancy Category C (see categories below). This indicates that the drug poses a significant risk to a growing fetus, and that there is data which indicates birth defects in humans.
In a study by the American Antiepileptic Drug Pregnancy Registry, it was shown 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 about the increased risk for development of a 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.
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 reclassified 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 revealed that women using antidepressants during pregnancy, as well as their newborns, have increased pathology. As a result, the categorization of SSRIs were questioned.
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)
FDA PREGNANCY CATEGORIES:
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is also 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 done 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. However, potential benefits may warrant use of the drug in pregnant women despite potential risks.
There is substantial evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. However, potential benefits may warrant use of the drug in pregnant women despite the potential risks.
Studies in animals or humans have demonstrated fetal abnormalities and/or there is substantial evidence of human fetal risk based on adverse reaction data from investigational or marketing experience. The risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Please call today to schedule your FREE consultation with Tucson Attorney Sarah J. Showard to discuss your case: (520) 622-3344 or toll free (866) 307-2147
Showard Law Firm
4703 E. Camp Lowell Drive, Suite 253
Tucson, AZ 85712
Sarah J. Showard, Attorney At Law
Se Habla Español
Trademark Notice: The use of the name of any product is strictly for identification purposes in attorney advertising. Showard Law Firm is in no way affiliated with the manufacturer of any product referenced on this site