Topamax Migraine Side Effects

Topamax belongs to a group of prescription medications known as anticonvulsants or anti-epileptics. The drug was first approved by the FDA in 1996 specifically for the treatment of generalized tonic-clonic and partial onset seizures associated with epilepsy. In 2004, the FDA added an additional indication for the prevention of severe headaches, or migraines. The active ingredient in Topamax is topiramate, and the drug functions by slowing down the firing of certain impulses in the brain which are responsible for causing seizure-related episodes. Topamax is currently manufactured by Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson.

While national estimates predict that 2.3 million Americans currently suffer from epilepsy, with 200,000 new cases diagnosed each year, an alarming 30 million Americans are believed to struggle with migraine headaches. Migraines can be an extremely serious condition, affecting three times more women than men, especially women of childbearing age who are particularly vulnerable to the debilitating headaches. According to the FDA, approximately 32.3 million prescriptions were filled for Topamax or generic Topamax between January 2007 and December 2010; a number of these prescriptions were presumably filled by pregnant women or women of childbearing age suffering from migraine headaches. Unfortunately, according to a number of studies, Topamax may no longer be considered a safe method of treatment, especially for pregnant women suffering from migraine headaches.

Topamax for Migraine Prevention

Anticonvulsant drugs like Topamax were initially developed to treat epilepsy and have since become a first-line defense against epileptic seizures. The medications have been approved for additional uses since their introduction, and have even been prescribed for off-label purposes when physicians find the treatment appropriate. Since its inception, Topamax has become extremely popular in reducing the frequency and intensity of migraine headaches, a purpose for which the drug may no longer be appropriate. Unfortunately, women of childbearing age across the United States continue to take anticonvulsant drugs like Topamax. Because many birth defects are established during the first trimester of pregnancy, and because nearly half of all pregnancies are unplanned, all women of childbearing age taking Topamax may be at risk of suffering Topamax migraine side effects.

Potential Topamax Birth Defect Side Effects

According to studies published by the New England Journal of Medicine and the journal Neurology, as well as data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, women who take Topamax for migraine prevention may significantly increase their risk of giving birth to infants with major birth defects, including cleft lip, cleft palate and genital defects like hypospadias. Cleft lip and cleft palate are malformations affecting an infant’s upper lip or palate, respectively, in which a lack of adequate tissues prevents the oral structures from forming properly in utero.

Cleft lip is characterized by a vertical fissure in one or both sides of the lip, varying in severity from a mild notch in the lip to a significant opening which may extend up through the nose. Cleft palate presents as an opening in the roof of the mouth, or palate, which can range from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth. These birth defects can lead to serious complications for an affected child, including feeding difficulties, frequent ear infections, hearing loss, and speech and language delay.

Hypospadias is a malformation affecting a male infant’s genitals in which the opening of the urethra is located on the underside, rather than at the end, of the penis. In minor cases, the opening may be located near the tip of the penis, while more severe instances are characterized by an opening at the midshaft or base of the penis, or even in or behind the scrotum. Without treatment, hypospadias can cause problems with urination, having to sit down to urinate, a malformed foreskin, difficulty during toilet training, and problems with sexual intercourse later in life.

FDA Warnings and Topamax Birth Defect Studies

A number of studies have been conducted in recent years in which researchers have sought to examine potential Topamax migraine side effects among women who take Topamax in pregnancy. According to this emerging body of research, infants whose mothers take Topamax while pregnant may have a significantly increased risk of being born with one or more major birth defects. In fact, according to a study published in the NEJM in 2001, anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.

More recently, the FDA issued a safety announcement warning patients and healthcare providers about the increased risk of cleft lip and cleft palate among infants exposed to topiramate (Topamax) during pregnancy. This FDA decision was made based on information provided by the NAAED Pregnancy Registry that same year. According to data collected by the registry, the prevalence of oral clefts was 1.4% among infants exposed to Topamax in utero, compared to the prevalence among infants exposed to other anticonvulsant drugs (0.38-0.55%), and the prevalence among infants not exposed to any anticonvulsants (0.07%).

In 2008, the journal Neurology published a study which indicated that infants born to women who took Topamax while pregnant had an increased chance of being born with serious birth defects. According to this report, infants whose mothers took Topamax during pregnancy were eleven times more likely to develop birth defects like cleft lip and cleft palate, and fourteen times more likely to be born with genital defects like hypospadias. Despite these potential Topamax migraine side effects, Topamax remains on the U.S. market today, available to millions of consumers across the country, including women of childbearing age suffering from migraine headaches.

Alleged Dangers of Topamax Use in Pregnancy

The pregnancy category has been elevated by the FDA from C to D, which means there is positive human evidence of the drug’s potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. According to a spokesperson for the American Academy of Neurology, the tolerance for risk is different for epilepsy patients, compared to patients taking Topamax to prevent migraine headaches, since seizures can present a significant danger to the fetus. Although migraines can be a debilitating condition for the mother, they generally do not pose a danger to the fetus.

If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately to discuss alternative treatment options. Because taking Topamax during pregnancy may result in severe birth defects in exposed infants, the potential risks of the treatment may significantly outweigh the possible benefits of the treatment. While women with epilepsy may be aware of the alleged dangers of taking Topamax, many women taking Topamax to prevent migraine headaches may be unaware of potential Topamax migraine side effects.

Topamax Attorneys for Topamax Migraine Side Effects

Women taking Topamax to treat epilepsy are likely to have received extensive information concerning the potential side effects of Topamax use. Unfortunately, women suffering from migraine headaches may have been taking the medication for a shorter period of time, and may not be aware of the potential risks of the drug, which may be severe enough to actually outweigh any advantages the medication may have. If you or a loved one has suffered from a potential Topamax migraine side effect, contact an experienced Topamax attorney to discuss the benefits of filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson). The goal of Topamax lawsuits and potential Topamax class action lawsuits is to seek financial compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs already on the market. With the help of an experienced Topamax lawyer, victims of alleged Topamax side effects or birth defects can feel confident that their rights are being protected and their case is being respectfully and effectively represented.