Topamax Side Effects in Women

Topamax is a prescription anticonvulsant medication manufactured by Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson. Although anticonvulsant drugs were originally developed as a treatment for epileptic seizures, these drugs have been approved for additional purposes in recent years, and have even been used for off-label purposes when physicians see fit. Topamax, for example, was approved by the FDA in 1996 to treat individuals suffering from generalized tonic-clonic seizures and partial onset seizures associated with epilepsy. In 2004 however, the FDA added an indication for the prevention of migraine headaches. The active ingredient in Topamax is topiramate, and the drug works by slowing down certain impulses in the brain which are responsible for causing seizure-related episodes. Despite the fact that Topamax and other anticonvulsant drugs have come to be known as the first-line of defense against epileptic seizures, and have even become a major force against migraines, these medications in particular have come under fire recently due to new information regarding the potential side effects of Topamax in women.

Topamax Side Effects in Women During Pregnancy

In recent years, serious concerns have been raised about the safety of Topamax, especially in treating pregnant women. A number of studies have sought to evaluate the possibility of Topamax side effects in women who took the drug while pregnant. Researchers have found a potential connection between Topamax use during pregnancy and serious side effects, particularly birth defects among infants exposed to the drug in utero. According to credible medical journals like the New England Journal of Medicine and Neurology, taking Topamax in pregnancy may result in severe birth defects among infants whose mothers took the drug while pregnant. Among these alleged Topamax birth defects are craniofacial malformations like cleft lip and cleft palate, and genital birth defects like hypospadias.

Cleft lip is a birth defect occurring when a child’s upper lip fails to form properly in utero. If there is an inadequate amount of cells in the lip area as the fetus is developing, the child may be born with a cleft lip. This malformation is characterized by a vertical fissure in one or both sides of the upper lip, and can vary in degree from a mild notch in the lip to a significant opening that can extend up through the nose. Similarly, cleft palate occurs when a child’s palate, or roof of the mouth, doesn’t fuse together completely during fetal development. This results in an opening in the roof of the mouth, which can be severe enough to cause complications like chronic ear infections, feeding difficulties, hearing loss, and even delays in speech and language development.

Hypospadias is a genital defect involving the malformation of a male infant’s genitals. In infants with hypospadias, the opening of the urethra is located on the underside, rather than at the end, of the penis. In minor cases of hypospadias, the opening may be located near the tip of the penis, but on the underside. In more severe instances, the opening may be located at the midshaft or base of the penis, or even in or behind the scrotum. Male infants who suffer from hypospadias may struggle with difficulties like abnormal spraying of urine, a malformed foreskin which makes the penis look hooded, difficulties in toilet training, and even problems with sexual intercourse later in life.

FDA Warnings Regarding Topamax Side Effects

The FDA has 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 notification was directly influenced by data gathered by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. According to this information, the prevalence of oral clefts among infants exposed to Topamax was 1.4%, significantly higher than the prevalence among infants exposed to other anticonvulsant drugs (0.38-0.55%), and the prevalence among infants exposed to no anticonvulsant drugs (0.07%).

The FDA has also advised pregnant women against taking Topamax in pregnancy unless all other available treatment methods have failed. In 2008, the journal Neurology published a study in which researchers found an eleven-times increased birth defect risk of cleft lip and cleft palate among infants whose mothers took Topamax in pregnancy, compared to the rate among infants whose mothers received no anticonvulsant treatment. Researchers also found a fourteen-times increased risk of genital defects like hypospadias among infants exposed to Topamax in utero.

Potential Dangers of Topamax in Pregnancy

After reviewing new information concerning possible Topamax side effects in women, the FDA has increased the pregnancy category of Topamax from C to D, the second highest classification possible. Physicians have been advised by the FDA to avoid prescribing category D medications to pregnant women due to the concern that taking Topamax in pregnancy may result in serious birth defects. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your healthcare provider immediately to discuss alternative treatment options. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you and your child. With the help of a medical professional though, you can research and choose a medication that will effectively treat your condition without causing you or your child any unnecessary harm.

Topamax Attorneys for Topamax Side Effects in Women

The alleged side effects of Topamax use in women are serious and have the potential to cause severe physical difficulties for an affected child, as well as a significant emotional and financial burden for the child’s family. If you or a loved one has suffered from a serious side effect or birth defect, and you believe Topamax to be the cause, contact a Topamax attorney to discuss your legal options. You may have grounds to file a Topamax lawsuit against manufacturing company, Ortho-McNeil (Johnson & Johnson), or be part of a potential Topamax class action lawsuit in order to seek financial compensation for your injuries and medical bills, as well as the pain and suffering sustained by you and your family. Victims of dangerous drug injuries should not be held accountable for their injuries or the extensive medical expenses resulting from treating their injuries. The main goal of Topamax lawyers is to protect the rights of alleged Topamax birth defect victims, and to help these victims collect the compensation they are entitled to. With the help of a qualified Topamax attorney, you can feel confident that you will be respected and your case will be represented in an effective and professional manner.