According to the Food and Drug Administration, Topamax should be closely monitored for increases in depression and potential mood changes that may result in an increase of suicidal thoughts. Topamax is a migraine and anticonvulsant medication linked to an increased risk of birth defects, specifically oral. Oral birth defects include cleft lip and cleft palate and occur in the first trimester of pregnancy when the lip or palate fails to fuse properly during development.
A pregnant woman taking Topamax during the first trimester is 20 times likely to risk their child developing an oral birth defect than a woman not taking the medication, says Reuters. The FDA warns pregnant women that they are at risk of having a baby develop the facial anomalies when exposed to dangerous drugs such as Topamax.
While Topamax has an FDA-approved seal to treat seizures and migraine headaches, it is being used off-label by doctors and health care providers for treatment of psychiatric conditions. Topamax made Johnson and Johnson $2 billion last year, thanks in part to its successful drug sales rep marketing campaign.
The FDA fined Johnson and Johnson for illegally marketing Topamax for psychiatric conditions. Despite the action, it has become a catch-all drug for a variety of pain conditions and other unapproved uses. It is used in the military and is known to cause brain-fogging, says Army Times.
In 2004, the FDA issued another warning to the drug maker, alleging its sales material downplayed the serious side effects associated with Topamax. The FDA raised concern over dangerous side effects such as acute myopia, secondary angle closure glaucoma, hyperthermia, metabolic acidosis and serious public health concerns in pediatric patients.
