Topamax While Breastfeeding

Topamax is one of a group of prescription medications called anticonvulsants, which were initially developed for individuals suffering from epileptic seizures. Topamax is commonly used by itself or in combination with other anticonvulsant drugs to treat epilepsy. Topamax was originally approved by the FDA in 1996 for treatment of generalized tonic-clonic and partial-onset seizures associated with epilepsy. In 2004, the FDA added an indication for the prevention of migraine headaches. The active ingredient in Topamax is topiramate, and the drug works by inhibiting the firing of certain impulses in the brain which are responsible for causing seizures. Topamax is currently manufactured by Ortho-McNeil Pharmaceutical, a division of drug company, Johnson & Johnson.

Although Topamax and other anticonvulsants have been embraced and prescribed by physicians across the United States, a number of recent studies have identified the side effects from the use of these medications as a risk factor for the development of major birth defects among infants. According to an emerging body of research, women who take Topamax while pregnant may significantly increase their risk of giving birth to infants with one or more serious birth defects. Among these alleged Topamax birth defects are cleft palate, cleft lip and genital defects like hypospadias. In addition, the FDA has alerted patients and healthcare providers that Topamax (topiramate) can and will pass into breast milk, raising serious concerns about the safety of taking Topamax while breastfeeding. Topamax is most often prescribed for epilepsy and as a preventative measure against migraine headaches. Unfortunately, Topamax may no longer be appropriate in the treatment of either of these conditions, especially in women who are pregnant, planning to become pregnant, or are breastfeeding.

Topamax and Epilepsy

Epilepsy is a brain disorder in which an affected individual suffers from repeated spontaneous seizures triggered by abnormally excited brain signals. Epilepsy can severely affect several aspects of a person’s life, including behavior and attention, due to disturbances in brain function. Unfortunately, according to the Centers for Disease Control and Prevention, epilepsy affects approximately 2.3 million Americans, with 200,000 new cases diagnosed each year.

The types of seizures most often associated with epilepsy are generalized tonic-clonic and partial-onset seizures. The presence of tonic-clonic seizures represents one of the most serious forms of epilepsy, typically affecting the entire brain. This type of seizure occurs in two stages, beginning with a stiffening of the limbs (tonic), followed by a jerking of the face and limbs (clonic). Partial-onset seizures are relatively common, accounting for nearly 60% of all seizures, and typically occur in one area of the brain. Partial-onset seizures are classified as either simple or complex: simple partial-onset seizures are less severe and are characterized by an unpleasant smell, abnormal sensations, or an irregular body movement, such as a jerk of the arm or leg. Complex partial-onset seizures, however, are most significant and typically involve staring, a loss of awareness, confusion, and irregular body movements, including uncontrolled shouting or rubbing hands together.

Topamax and Migraine Headaches

Migraine headaches occur when blood vessels become enlarged, causing the release of chemicals from nerve fibers surrounding the large arteries of the brain. These chemicals cause pain, inflammation, and further enlargement of the artery, which magnifies pain. Migraines are believed to activate the body’s sympathetic nervous system, which controls primitive responses to pain and stress. This activation is what causes many of the symptoms commonly associated with migraine headaches, including nausea, diarrhea and vomiting. According to national estimates, nearly 30 million Americans suffer from migraine headaches, an extremely debilitating condition which can affect personal and social relationships and performance at work or school, among other aspects of daily life. Migraines affect three times more women than men, with women of childbearing age being especially vulnerable to these severe headaches.

Potential Dangers of Topamax While Breastfeeding

According to the FDA, topiramate (Topamax) can pass into breast milk and may harm a nursing baby. For this reason, you should never take Topamax without telling your healthcare provider that you are breastfeeding your child. Topamax is passed through breast milk in relatively low amounts and in a few small studies involving Topamax use while breastfeeding, no problems were seen in the infant. However, children as young as two years old who take Topamax may experience side effects like confusion, aggressiveness, drowsiness, infections, weight loss and appetite loss. It is possible that these side effects may also present in children who are exposed to Topamax through breast milk. If your physician recommends taking Topamax while breastfeeding, you should be aware of these side effects and watch out for them in your infant. Because of the side effects that may affect a nursing infant exposed to Topamax through breast milk, physicians are advised to consider all risks and benefits before recommending Topamax to women who are breastfeeding. If you are taking Topamax, talk to your physician about the best way to breastfeed your baby; in most cases, mothers who require Topamax treatment are encouraged to bottle feed their infants.

Topamax Use During Pregnancy

While the potentially harmful side effects in children of Topamax use while breastfeeding is largely unknown, there is a large body of research which has examined the adverse effects of fetal exposure to Topamax during pregnancy. After reviewing the results of this research, the FDA has elevated the pregnancy category of Topamax from C to D, signifying that there is positive human evidence illustrating the drug’s potential to cause significant, unreasonable harm to a fetus when taken during pregnancy. The FDA has also advised healthcare providers to avoid prescribing Topamax to pregnant women unless the possible benefits of the treatment justify the potential side effect risks to the fetus including the development of cleft palate, cleft lip, and hypospadias genital defects.

As a spokesperson for the American Academy of Neurology states, Topamax may no longer be considered an appropriate treatment for pregnant women suffering from migraine headaches. However, the tolerance for risk for migraine headache patients is different for epilepsy patients. Epileptic seizures can cause serious injury to both mother and child, making it necessary for pregnant women to control these seizures with Topamax, despite the potential for the drug to cause serious birth defects including cleft lip in infants. Although migraines can be a debilitating condition for the mother, they typically do not pose a danger to the fetus. Therefore, for women who are pregnant or breastfeeding, Topamax use may cause side effects that are significant enough to outweigh even the benefits of the treatment, especially for women taking the drug to prevent migraines.

Contact a Topamax Attorney for Help

Although there is currently no definite information concerning Topamax use while breastfeeding, the information that is available regarding the potential dangers of Topamax indicates that the drug may cause serious harm when taken during breastfeeding. If you took the anticonvulsant drug Topamax while breastfeeding and your child has suffered serious side effects, contact a Topamax attorney to discuss your legal options. Your child may be entitled to life-long care or financial compensation for his injuries and medical expenses, which you can collect by filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson).

According to a antiepileptic side effects study published by the New England Journal of Medicine in 2001, anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. Although a decade has passed since this study was conducted, the adverse side effects of Topamax use on children are still being examined. With new information concerning alleged Topamax side effects and the consequences of exposure to Topamax in breast milk, the FDA may apply new restrictions on the use of Topamax. For the time being, women who are pregnant, planning to become pregnant, or breastfeeding should avoid taking Topamax whenever possible. For those who have been adversely affected by Topamax, it is the main goal of Topamax lawyers to protect the rights of potential Topamax birth defect victims, and to help victims of alleged Topamax side effects collect the compensation they deserve by filing a Topamax lawsuit or join a potential Topamax class action lawsuit.