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Topamax
Topamax Has Been Linked to Severe Birth Defects
If You Took Topamax During Early Pregnancy and Had a Baby Born with Birth Defects, You Could Be Eligible for Compensation Through a Topamax Lawsuit.
Topamax® is a drug commonly prescribed to treat epilepsy and migraines. On March 4, 2011, the FDA announced new data suggesting that babies born to women who took Topamax during their first trimester have an increased risk of birth defects. In fact, the increased risks are severe.
Birth defects associated with Topamax use during the first trimester of pregnancy include but may not limited to:
- Cleft Lip
- Cleft Palate
- Genital Defects
- Fetal and Skeletal Malformations
A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a split or gap in the roof of the mouth. Such deformities may cause developmental issues and can lead to severe ear infections and problems with eating and talking.
If your child was born with a birth defect and you took Topamax while pregnant, you may be entitled to compensation. To learn more, contact us today to receive a free initial consultation with a Topamax lawyer.
Background Topamax Facts:
Topamax was originally approved by the FDA on December 24, 1996 to treat total and partial seizures. In 2004, Topamax was approved to treat migraines. Many women took Topamax to prevent seizures during their pregnancy. Unfortunately, such use could also harm the development of the fetus. Even so, on March 4th of 2011, the FDA reported to doctors that when Topamax is compared to other epileptic preventative drugs, the “alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.” The Topamax lawyers at The Byrd Law Firm believe that when a company should be held responsible when it endangers its customers unnecessarily like this.
The FDA also noted in their letter that many oral cleft and other malformations occur during the first trimester when the pregnant patient is taking Topamax. Because there is generally a two weeks gap between first conception and the first sign of pregnancy, often women taking Topamax for epilepsy or migraines will be taking Topamax during the first trimester before they even see a doctor or realize that they are pregnant. Topamax drug manufacturer Ortho-McNeil was required to update the Topamax warning label with the risk and the FDA moved Topamax from a “Category C” drug, to the more dangerous drug classification “Category D.” Pregnancy “Category D means there is “positive evidence of human fetal risk based on human data.”
The Topamax Studies:
On March 4, 2011, the Food and Drug Administration (FDA) issued a safety warning after a NAAED Pregnancy Registry study showed Topamax increases the malformation risk to newborns. In the study it was reported that the incidence of newborns with oral clefts more than doubled in women exposed to Topamax during their pregnancy than the women who were not exposed to Topamax.
Also, a Topamax study conducted in the UK titled “Topiramate in Pregnancy: Preliminary Experience from the UK Epielpsy and Pregnancy Register”, reported that of the 178 births studied, 31 (17.4%) resulted in some form of malformation and 16 (9%) resulted in a oral clefts, hypospadias or other major malformations.
Moreover, in the journal Epilepsia in 2006 a Topamax study titled “Pregnancy Outcomes in Topiramate-treated women” reported that 9 of the 78 pregnant women studied resulted in oral clefts or some other form of malformation
Topamax Manufacturer Has Plead Guilty to Government Allegation:
In 2003, the United Stated Government held that Johnson & Johnson subsidiaries Ortho-McNeil Pharmacueticals and Ortho-McNeil Janseen Pharmacuetical Inc. illegally marketed Topamax for off-label use. The government held that Ortho-McNeil had hired speakers to promote the off-label use of Topamax. In 2010, Johnson & Johnson and Ortho-McNeil plead guilty to one misdemeanor and settled for $81 Million to end the government’s investigation.
If your child was born with a birth defect and you took Topamax while pregnant, you may be entitled to compensation. To learn more, contact us today to receive a free initial consultation with a Topamax attorney.