Topamax During Pregnancy

Taking Topamax during pregnancy may increase the risk of developing birth defects such as cleft lip, cleft palate and genital defects. Topamax lawyers can provide important individual and class action lawsuit information for side effect victims.

Millions of Americans are currently suffering from debilitating seizures associated with epilepsy, and hundreds of thousands of new epilepsy cases are diagnosed each year. One of the most common treatment methods for epileptic seizures is the use of anticonvulsant medications like Topamax. Antiepileptic drugs like Topamax have also become one of the primary methods of migraine headache prevention, a condition which affects a shocking 30 million people in the United States alone, primarily women of childbearing age. Unfortunately, recent research has indicated that women who take anticonvulsant drugs like Topamax while pregnant may significantly increase their chances of giving birth to children with one or more major birth defects. Because nearly half of all pregnancies are unplanned, women of childbearing age who take Topamax may cause irreversible harm to their unborn children before they are even aware they are pregnant. More information regarding the potentially harmful side effects of Topamax use during pregnancy and the birth defects allegedly associated with the drug can be found below.

Topamax Described

Topamax is a prescription anticonvulsant medication which has been approved by the FDA for use by itself or in combination with other anticonvulsant drugs for the prevention of migraine headaches in adults and the treatment of epilepsy in individuals ten years and older. The drug was FDA-approved in 1996 to treat primary generalized tonic-clonic seizures and partial onset seizures associated with epilepsy, and the indication for the prevention of migraines was added by the FDA in 2004. Topamax functions by interfering with certain impulses in the brain which are responsible for causing seizure-related episodes, thereby decreasing the frequency of seizures. The active ingredient in Topamax is topiramate and the drug is currently manufactured by pharmaceutical giant, Johnson & Johnson.

Topamax and Birth Defects

“Victims of serious injuries or birth defects possibly associated with the use of Topamax are not at fault.”

The birth defects allegedly associated with the use of Topamax during pregnancy may cause severe complications for an affected child, some of which may have long-term consequences requiring extensive and costly medical care, including reconstructive surgery.

• Cleft lip
• Cleft palate
• Genital birth defects like hypospadias

Cleft lip and cleft palate are both craniofacial malformations which affect the development of certain oral structures in utero. In infants with cleft lip, there is a lack of tissue in the lip area during fetal development, which can result one or two vertical fissures in the upper lip. A cleft lip can occur on one or both sides of the mouth and can vary in severity from a mild notch in the upper lip to a severe crevice which may extend up through the nose. A cleft palate is similar in nature to a cleft lip, but involves a lack of tissue in the palate area, or roof of the mouth, during fetal development. A cleft palate can involve the bony front portion of the mouth or the soft back portion of the mouth, and can vary in degree from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth. Children with cleft lip and cleft palate typically suffer from significant complications, including chronic ear infections, hearing loss, feeding difficulties, speech and language delay, and missing or malformed teeth.

Hypospadias is a congenital birth defect affecting the structure of the genitals in male infants. Children with hypospadias are born with the opening of the urethra located on the underside, rather than at the end, of the penis. In some instances, the opening may be near the tip of the penis, but on the underside, while more severe cases present with the opening at the midshaft or base of the penis, or sometimes in or behind the scrotum. Infants with this condition typically struggle with abnormal spraying during urination, which may require the child to sit down to urinate, and a malformed foreskin which makes the penis look hooded. Without treatment, infants with hypospadias may suffer from major difficulties later in life, including during toilet training and sexual intercourse.

Topamax and Birth Defect Studies

Two of the most credible Topamax birth defect sources have provided revealing information regarding the possible link between Topamax use during pregnancy and the development of major birth defects among infants exposed to the drug in utero. According to a 2008 study on antiepileptic side effects published in the journal Neurology, infants born to women who took Topamax during pregnancy were significantly more likely to be born with birth defects like cleft lip, cleft palate, and genital defects like hypospadias, compared to infants whose mothers didn’t take the drug while pregnant. Researchers indicated that, of the 178 live births reviewed in the study, sixteen infants were born with major birth defects. Three of the sixteen mothers took Topamax by itself while pregnant, and thirteen mothers took Topamax in combination with another anticonvulsant drug. Among the sixteen affected infants, four were born with cleft lip or cleft palate, a rate eleven times what would be considered normal among the general population. Four other infants were born with genital defects like hypospadias, a rate fourteen times what would be considered normal. Furthermore, researchers determined that the birth defect rate was even higher among infants whose mothers took Topamax in combination with valproate, the active ingredient in the anticonvulsant drug, Depakote.

According to data collected by the North American Antiepileptic Drug Pregnancy Registry and reviewed by the FDA, 1.4% of infants whose mothers became pregnant while taking Topamax were born with cleft palate or cleft lip, compared to 0.38-0.55% of infants born with these defects whose mothers took other anticonvulsant drugs while pregnant, and 0.07% of infants whose mothers received no anticonvulsant or antiepileptic treatment during pregnancy. Shortly after this data was revealed, the FDA issued a safety announcement concerning the potential connection between Topamax use during pregnancy and the risk of oral defects like cleft lip and cleft palate.

Topamax Use During Pregnancy

The FDA has elevated the pregnancy category of Topamax from C to D, which means there is positive human evidence regarding the potential for Topamax side effects to cause harm to a human fetus when taken during pregnancy. Because of this, the FDA has advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately. It is never advised to terminate use of a prescription medication without your doctor’s consent, but together you may be able to find a safer alternative to Topamax for treating your medical condition.

Contact Topamax Attorneys for Help

Victims of serious injuries or birth defects potentially associated with the side effects of an allegedly defective drug are not at fault. If you or a loved one has suffered from an antiepileptic adverse side effect or birth defect which you believe to be linked to the use of the anticonvulsant drug, Topamax, contact a Topamax attorney to discuss your legal options. You may be entitled to reimbursement for your injuries which you can collect by filing a Topamax lawsuit against manufacturing company, Johnson & Johnson. The goal of potential Topamax lawsuits and Topamax class action lawsuits is to seek financial compensation for your injuries and the medical expenses resulting from treating your injuries, as well as the pain and suffering endured by you and your family.

Drug manufacturing companies should be held accountable for any adverse side effects sustained by consumers of their products, since it is their responsibility to manufacture safe drugs and to alert the public of any dangers potentially associated with their medications. Unfortunately, some pharmaceutical companies intentionally conceal this information in order to ensure their drug is well-received by the FDA and by the public. This puts consumers at risk of suffering severe injuries without the information necessary to make educated decisions regarding pharmaceutical drug use. The only way to protect your rights and receive the compensation you deserve is to hire an experienced Topamax lawyer to represent your case.