FDA Warning: Somnolence and Topamax
Many people are aware that Topamax causes birth defects in children born to mothers taking the drug at a rate of 20 times greater than those not using any antiepileptic medication. The U.S. Food and Drug Administration (FDA) is concerned because the types of birth defects, cleft lip and palate, form early enough in the pregnancy that women taking Topamax may not yet know they are pregnant. Consequently, it recommends women be extra careful and use birth control while on Topamax. Topamax, however, causes other side effects, in particular sleep disturbances, called “somnolence/fatigue” by the FDA. Somnolence means excessive tiredness, drowsiness, or being in a state of near-sleep.
In fact, the FDA requires a somnolence/fatigue warning on Topamax’s drug label in the “warnings and precautions” section. The severity of Topamax’s sleep side effects vary for those who use it to treat epilepsy and those who use it for migraines. For migraine sufferers, the incidence of somnolence and fatigue correlated with the dosage they used.
Topamax Sleep Side Effects in Epileptics
In epileptics, topamax sleep side effects are different. When used alone (you may have seen it as “monotherapy” in the medical literature), the rate of somnolence increased 1.7 times between 50mg/day and 400mg/day, but the rate of fatigue was equal between those doses at a rate of about 14%. By contrast, when Topamax was used with another antiepileptic drug (“adjunctive therapy”), the situation reverses. The incidence of fatigue is dose-dependent and increases above 400mg/day, but somnolence does not.
Somnolence can be quite dangerous. People engaged in dangerous, high-concentration tasks are at greater risk than those who feel rested. Those operating heavy machinery, especially automobiles, are far more likely to lose their alertness, stop paying attention, and may injure themselves and others in a car accident. It is very important to monitor this topamax symptoms and side effects and to consult your physician if there are any problems.
Additional Topamax Side Effects
Fortunately, somnolence and fatigue are easily monitored side effects of Topamax. Those who gave birth to children with cleft lip and palate, however, are not so fortunate. If this happened to your child, you may have legal rights against Ortho-McNeil and Johnson & Johnson for an amount of compensation relative to the harm your child suffered. If you are interested, the Rottenstein Law Group would like to extend to you a confidential consultation, free of charge, if you submit our contact form to the right or click on this link.