Topamax Possibly Linked to Birth Defects
According to the Center for Disease Control, approximately 2.3 million Americans struggle with epilepsy, and 200,000 new cases of this condition are diagnosed every year. Epilepsy is a neurological disorder which causes recurrent uncontrolled seizures in an affected person. Additionally, nearly 30 million Americans suffer from migraines, with women being three times more likely to suffer from debilitating migraines than men. In order to treat these conditions, physicians typically prescribe one of group of anticonvulsant medications, which includes the drug Topamax. In fact, Topamax has become one of the most widely-prescribed antiepileptic drugs on the market, particularly for women of childbearing age who are especially vulnerable to migraine headaches. Unfortunately, recent research has indicated a possible connection between Topamax use and a significantly increased risk of birth injuries like cleft lip, cleft palate, and genital defects such as hypospadias, in infants whose mothers took the drug while pregnant. Despite these risks, Topamax remains on the market today.
Topamax is a prescription anticonvulsant medication used to treat epileptic seizures, namely partial onset seizures and primary generalized tonic-clonic seizures, in individuals ten years and older, as well as migraine headaches in adults. Topamax is currently manufactured by Johnson & Johnson and was originally approved in the U.S. by the FDA in 1996 for the treatment of epilepsy in adults and children. In 2004, the FDA approved Topamax for the additional use of treating severe headaches, or migraines. Although the drug has only been approved for these two uses, Topamax is often used for off-label purposes like bipolar disorder. The active ingredient in Topamax is topiramate, which functions by slowing down the impulses in the brain which are responsible for causing seizure-related episodes. Topamax is used alone or in combination with other anticonvulsant medications to treat the seizures associated with epilepsy.
Topamax and Birth Defects Connection
In response to alleged Topamax and topiramate birth defect information, the FDA recently increased the drug’s pregnancy category from C to D, which means that the drug has the potential to cause significant, unreasonable harm to a human fetus. The FDA released a safety announcement regarding the alleged connection between the use of Topamax and topiramate during pregnancy and the development of oral malformations, like cleft lip and cleft palate, in infants who are exposed to the anticonvulsant drug in utero. The FDA advisory warns patients about the potential for Topamax birth defects and advises health professionals to avoid prescribing Topamax to women of childbearing age unless all other available treatment methods have failed.
According to a 2008 Topamax side effects study conducted in Ireland and published in the journal, Neurology, of the 203 women who became pregnant while taking Topamax, the risk of birth defects was allegedly higher than in women not taking an anticonvulsant medication. Of the 178 lives births reviewed by the researchers, four infants were born with cleft lip or cleft palate, which is a rate eleven times higher than would be expected among women not taking an antiepileptic medication. In addition, four male infants were born with genital defects, such as hypospadias, which is a rate fourteen times higher than normal.
According to recent research, the incidence of birth defects among women taking topiramate is higher than the birth defect rate of the normal population. Data collected by the North American Antiepileptic Drug Pregnancy Registry suggests that 1.4% of infants exposed to Topamax during pregnancy will develop cleft lip or cleft palate, compared to 0.38-0.55% of infants exposed to other anticonvulsant drugs, and 0.07% of infants whose mothers did not take anti-seizure drugs while pregnant. Additionally, for women who take Topamax in combination with the valproate drug Depakote, another anti-epileptic medication, the risk of giving birth to children with birth defects is exponentially higher, even when compared to women who take topiramate and another anti-epileptic drug together.
Topamax Use and Pregnancy
Topamax has been classified by the FDA as a pregnancy category D medication. Unfortunately, because nearly half of all pregnancies are unplanned, and because facial deformities like cleft lip and cleft palate are established during the first trimester of pregnancy, women of childbearing age who take Topamax during pregnancy may cause irreversible harm to their unborn child before they are even aware they are pregnant. If you are currently taking Topamax for migraines or epilepsy and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It is never encouraged to discontinue use of a prescription medication without consent, as this may cause further adverse side effects. However, with the aid of your doctor, you may be able to find a safer alternative to Topamax for treating your epilepsy.
Topamax Lawsuit Help is Available
The FDA estimates that approximately 32.3 million individuals filled prescriptions for Topamax or a generic form of the antiepileptic medication between January 2007 and December 2010. Unfortunately, a significant percentage of these prescriptions were issued to women of childbearing age suffering from migraine headaches, a condition for which Topamax may no longer be considered an appropriate treatment method. According to a spokesman for the American Academy of Neurology, the tolerance for risk is different for epilepsy patients, as seizures can pose a significant danger for a fetus. Although migraines can be painful for the mother, they generally do not pose a risk to the fetus. Therefore, the potential risks of a treatment for migraines which may result in the development of severe birth injuries may significantly outweigh the possible benefits of the drug.
If you or a loved one has suffered from a side effect or birth defect which you believed to be associated with the use of Topamax, contact a Topamax attorney to discuss the benefits of possibly filing a Topamax lawsuit. The goal of Topamax lawsuits or class action lawsuits for Topamax is to seek financial compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering sustained by you and your family. Defective drug lawsuits also bring public attention to the importance of safer medications and the need for more stringent regulations on the potentially dangerous drugs already on the market. Topamax lawyers are extremely qualified in defective drug litigation and with the help of this valuable resource, alleged Topamax birth defect victims can collect the compensation they deserve.