Birth Defect Lawsuits | Showard Law Firm

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. 

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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:

FDA PREGNANCY CATEGORIES:

Category A
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.

Category B
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.

Category C
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.

Category D
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.

Category X
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
info@showardlaw.com

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Showard Law Firm-Tucson's Local Law Firm for defective drug & medical device claims.

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Showard Law Firm is dedicated to compassionate representation for our clients who have been injured by defective products, dangerous drugs or the negligence of any individual or company. We are experienced in litigation and ready to ensure you receive the maximum possible settlement for your injuries, medical bills, mental anguish and other losses.

Showard Law Firm celebrates 10 years

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This year marks the 10th anniversary of Showard Law Firm. After 18 years of practice, and a prior ten-year partnership, Sarah Showard and her longtime assistant, Maria De La Rosa, opened the doors of Showard Law Firm in October 2006. Sarah and everyone at Showard Law Firm is proud to serve Southern Arizona as the local law firm for defective drug and medical device claims and personal injury. The entire team will be celebrating with an anniversary trip to San Francisco in October.