Topamax (topiramate) is a medication prescribed to patients suffering from epileptic seizures. Physicians have also prescribed Topamax to treat individuals with migraine headaches. The anti-seizure medication was developed by a Johnson & Johnson subsidiary, Ortho-McNeil-Janssen Pharmaceuticals Inc.
In March 2011, the U.S. Food and Drug Administration (FDA) acted to increase public and healthcare provider awareness about the birth defects caused by the use of Topamax during pregnancy. The warning released by the FDA noted the change in Topamax from a Pregnancy Category C drug to a Pregnancy Category D drug, meaning that there is direct evidence of the risk in unborn children to develop birth defects, especially oral malformations, if exposed to Topamax in the womb.
Birth defects that have been linked to Topamax exposure have been primarily those related to oral malformations. These oral birth defects are seen in the development of a cleft lip or a cleft palate. According to data released in 2011 from the North American Antiepileptic Drug (AED) Pregnancy Registry, the risk of developing an oral defect is 16 times higher in children exposed to Topamax while in the womb.
Furthermore, women currently taking Topamax who are considering pregnancy must consult with their physicians in order to weigh the risks. Topamax exposure for children in the womb is demonstrably dangerous, and adversely, discontinuing the use of a drug like Topamax may place both the mother and the child at risk in the event of an epileptic seizure.
Choices regarding Topamax must be weighed very carefully.
Our pharmaceutical product litigation attorneys at Carey Danis & Lowe have a proven track record of success in lawsuits that require battling huge pharmaceutical corporations such as Ortho-McNeil-Janssen Pharmaceuticals Inc. and Johnson & Johnson.
The experienced attorneys at Carey Danis & Lowe work hard to represent clients and provide them with expert legal counsel in Topamax birth defects lawsuits.
Winning our clients the justice and compensation they deserve is our top priority. To receive a free legal consultation and to file a Topamax birth defects lawsuit, submit a claims form today, or contact an attorney at Carey Danis & Lowe by calling 800.721.2519.
The FDA has categorized Topamax as a Pregnancy D drug meaning that there is positive evidence of an increased risk for congenital birth defects when taken during pregnancy.
Common Topamax birth defects include but are not limited to:
- Peripheral Arterial Disease (PAD)
- Persistent Pulmonary Hypertension (PPHN)
- Ventricular Septal Defects (holes in heart)
- Atrial Septal Defects (holes in heart)
- Gastrointestinal Malformations (GI Tract)
- Atrial Enlargement
- Tetrology of Fallot
- Transposition of Great Arteries (TGA)
- Pulmonary Stenosis
- Hypoplastic Right/Left Heart
- Truncus Arteriosus
- Neural Tube Defect
- Ebstein’s Anomaly
- Omphalocele (organs outside abdomen)
- Pierre Robbins Sequence
- Undescended Testes
- Club Foot
- Coarctation of the Aorta
- Other Related Injuries
Manufacturer: Janssen Pharmaceuticals
FDA Approval: December 24, 1996 for treatment of seizures and migraine headaches
Generic Availability: March 27, 2009
Pregnancy Risk: Category D