Topamax (topiramate) is in a class of medications called anticonvulsants. The drug is used to treat seizures in patients who have epilepsy, and to prevent the onset of migraine headaches. Your doctor may prescribe Topamax for other purposes, though the manufacturer is prohibited from marketing or promoting the drug for uses not specifically approved by the U.S. Food and Drug Administration (FDA).
Birth defects are among the most serious side effects associated with topiramate. Since 2011, the FDA has warned that infants born to mothers who used Topamax during pregnancy face an increased risk of developing cleft lip and/or cleft palate.
Cleft lip and cleft palate occur when a baby’s lip or mouth does not form properly. These malformations take place early during pregnancy and can occur together. Children with a cleft lip or cleft palate often have difficulty feeding and talking, and can suffer ear infections, hearing loss, and dental problems. Most cleft lip surgery is done before the child reaches the age of 12 months and cleft palate surgery before 18 months.
The FDA continues to advise women of childbearing age to carefully consider an alternative treatment option before using Topamax. If an alternative medication is not feasible, the FDA recommends that women use effective birth control in conjunction with Topamax. At the same time, topiramate may decrease the effectiveness of some types of birth control, so patients should consult their doctor about compatible contraceptive options.
Data on Topamax and Birth Defects
In 1997, Massachusetts General Hospital established the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of the registry is to determine the frequency of malformations such as heart defects, spina bifida, and cleft lip in babies born to mothers treated with different anticonvulsants during pregnancy.
The registry concluded that the prevalence of oral clefts was 1.4% in infants exposed to topiramate during the first trimester. Other antiepileptic drugs only carried a prevalence of 0.38% – 0.55%, while the prevalence in infants who were not exposed to any antiepileptic drugs was 0.07%. This means Topamax carries a 2 to 4-fold increase in risk compared to alternative seizure medications, and a 20-fold increase in risk over non-users.
The UK Epilepsy and Pregnancy Register reached similar findings, with a 3.2% increased prevalence of oral cleft with topiramate compared to 0.2% among non-users. This represents a 16-fold increase in the risk of oral birth defects with use of Topamax.
Other Side Effects of Topamax
In addition to fetal harm, Topamax side effects can include the following:
- Worsening of seizures
- Osteoporosis in adults
- Rickets in children (abnormal, curved bone growth)
- Slow growth and shorter height in children
- Depression
- Suicidal thoughts
- Speech problems
- Memory problems
- Lack of coordination
- Aggressive behavior and irritability
- Uncontrollable shaking
- Uncontrollable eye movements
- Change in taste and other oral conditions
- Excessive menstrual bleeding
- Skin and hair problems
- Ringing in the ears
- Sleep disturbances
- Chest pain
- Intense back or side pain
- Difficulty breathing
- Urinary problems
- Blurred or double vision
- Pounding or irregular heartbeat
As with other medications, patients can also overdose while taking Topamax and require emergency care.
Topamax Litigation
Lawsuits against the manufacturer of Topamax are ongoing for the company’s alleged failure to adequately warn consumers about birth defects. More information about the Topamax lawsuit is available on this website. You can also speak to one of our Topamax attorneys at no cost about a potential claim if your family has been affected by birth defects from this medication.