Category D for Topamax Side Effects

Pregnant women are often vulnerable to side-effects for drugs they are relatively safe under different circumstances, such as the anti-epilepsy drug Topamax (topiramate). While the mothers themselves may not suffer permanent damage, birth defects can ensue with certain drugs. An unborn child is in rapid development; changes in the mother’s food and medication intake has a significant impact on the child. For this reason, the US Food and Drug Administration (FDA) created a categorization for drugs specifically for pregnant women.

There are 5 FDA pregnancy categories, ranging from “safe” (no evidence of risk of birth defects) to “dangerous” (clear evidence of high risk of birth defects). Prescription drugs that may have been in the market for years under a safe category may be moved to another category if there is new evidence regarding its effects on a pregnant woman. There have been numerous instances when this has happened, such as when adverse Topamax side effects began to emerge. Unfortunately, this means some harm has already occurred to either the mother or the child, and it is usually the child.

Category A is considered safe for pregnant women. The FDA does not actually call any drug “safe.” Rather, it states that studies “failed to demonstrate a risk to the fetus.” Category B drugs are also considered safe for pregnant women, except that the FDA qualifies that there have been “no adequate and well-controlled studies in pregnant women.” So if further studies show otherwise, the drug can be moved to Category C.

Category C drugs already demonstrated adverse effects on animal fetuses, although “no adequate and well-controlled studies in humans” have yet been carried out, and it is believed any risk is outweighed by the benefits of the drug. So this is more or less a tossup, and hopefully no real harm happens to the child or the mother with its use. Topamax used to be a Category C drug before complaints started to come in. It is currently a Category D, which has been shown to have “evidence of human fetal risk.” In the case of Topamax, it has been implicated in the increased number of children of mothers taking Topamax born with birth defects (oral-facial clefts). Even if a drug is under Category D, some physicians can still prescribe it provided the dangers are clearly explained to the patient.

Under Category X, however, the benefits of the drugs thus classified are considered to be outweighed by the risks it represents to pregnant women and their unborn children. Doctors will only prescribe this to women if they are not pregnant and under birth control medication, under strict supervision and if there is no other alternative.

Topamax manufacturer Johnson & Johnson has issued new labels in 2011 to reflect this risk, but for some children it may be too late. If you or someone you know has a child born with oral-facial clefts due to Topamax side effects prior to 2011, contact a birth defects lawyer in your area to see if you are eligible for a personal injury claim.

Leave a Comment

Your email address will not be published. Required fields are marked *