Topamax Birth Defects

Topamax birth defects may stem from side effects of Topamax use in pregnancy and attorneys are filing Topamax lawsuits on behalf of families affected. Contact a Topamax lawyer for class action and lawsuit information.

New Topamax side effect studies indicate that Topamax use during pregnancy may be associated with a significantly increased risk of Topamax birth defects among exposed infants. Topamax is a prescription anticonvulsant drug manufactured by Ortho-McNeil Pharmaceutical, which is a subsidiary of pharmaceutical giant Johnson & Johnson. Topamax was approved by the FDA in 1996 for the treatment of epilepsy, and again in 2004 for the prevention of migraine headaches. The active ingredient in Topamax is topiramate, and the drug works by slowing down the firing of certain impulses in the brain which are responsible for causing seizures. Since its introduction, Topamax has become one of the most commonly prescribed anticonvulsant drugs available, particularly for the prevention of migraine headaches, a condition which affects more women of childbearing age than any other population in the U.S. Unfortunately, an emerging body of research has identified Topamax use during pregnancy as a possible risk factor for the development of serious birth defects among children. If you took Topamax while pregnant and your child was born with a birth defect, contact a Topamax attorney to discuss your legal options.

As new Topamax birth defect studies are published, researchers and FDA officials have warned pregnant women and women of childbearing age about the potential for the anticonvulsant drug to cause serious fetal harm. In fact, the FDA has elevated the pregnancy category of Topamax from C to D, which means there is positive human evidence of the drug's potential to cause severe harm to a fetus when taken during pregnancy. The FDA has also advised physicians to consider all benefits and risks of Topamax before prescribing the drug to women of childbearing age, especially for conditions not usually associated with permanent injury or death. The agency suggests that alternative medications associated with a lower risk of birth defects be considered for these patients.

Cleft Lip and Cleft Palate Birth Defects

Among the birth defects potentially associated with Topamax use in pregnancy are craniofacial defects like cleft lip and cleft palate, and genital defects like hypospadias. Cleft lip is characterized by a vertical fissure in one or both sides of the upper lip, which may even extend up through the nose in serious cases. Cleft palate is caused by the incomplete development of the palate, or roof of the mouth, during fetal development. This birth defect can range in severity from a small opening at the back of the mouth to a large gap in the roof of the mouth. Both cleft lip and cleft palate can cause major side effects like difficulty feeding, chronic ear infections, hearing loss, missing or malformed teeth, and speech and language delays.

Hypospadias Birth Defects

Hypospadias is a congenital defect involving the malformation of a male infant's genitals in utero. In children born with hypospadias, the opening of the urethra is located on the underside, rather than at the end, of the penis. In some cases the opening may be located near the end of the penis, but more severe instances present with the opening located at the mid-shaft or base of the penis, or even in or behind the scrotum. Infants with hypospadias may struggle with major complications like problems during urination, a malformed foreskin, a curved penis, and difficulties during toilet training and sexual intercourse later in life.

Topamax Use in Pregnancy and FDA Warnings

In March 2011, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of cleft lip and cleft palate among infants whose mothers took Topamax during early pregnancy. This FDA notice was largely influenced by Topamax birth defect data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. According to this data, infants born to women who took Topamax during the first trimester of pregnancy were twenty times more likely to develop an oral cleft than infants whose mothers received no anticonvulsant treatment while pregnant. According to another study published in the journal Neurology in 2008, infants exposed to Topamax during pregnancy were eleven times more likely to be born with an oral cleft, and fourteen times more likely to be born with hypospadias, compared to the expected birth defect rate among the general population.

Topamax Birth Defect Legal Help

One of the most important steps to take following a birth defect diagnosis is to hire a Topamax attorney to represent your case. Children born with birth defects typically require significant medical treatment, which may extend throughout the course of their lives. Unfortunately, the medical costs associated with birth defect treatment may be an overwhelming financial burden for many families. With the help of an experienced Topamax lawyer, potential birth defect victims and their families can receive the legal help they need in order to collect financial reimbursement. If you or a loved one has suffered from a birth defect which you believe to be associated with Topamax, you may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Topamax lawsuit against Ortho-McNeil (Johnson & Johnson). By hiring a Topamax attorney to represent your case, you can collect the compensation you deserve and protect yourself and your family from further harm.

Prescription Drugs in The News