Topamax, more widely known as Topiramate, is an anticonvulsant generic medicine or drug for people suffering from migraine attacks and epileptic seizures. Manufactured by Johnson & Johnson and made available in 1996, it came as a very timely medication that relieved the excruciating pains brought about by migraine, as well as attacks due to epilepsy. It reduced the pain and held back seizures by controlling nerve signals and, based on the effects it had then, Topamax showed to be much more effective than any other brand.
Its efficacy made it the top choice of both doctors and patients, including pregnant women. Not long after, though, stories about the drug’s severe side effects, most serious on unborn children, began to be recorded. The website of Williams Kherkher explains that the three widespread side-effects identified with Topamax are cleft palate, cleft lip, and hypospadias, a flaw that puts the urethra at the underside of the male organ; the urethra is the passageway of the urine from the bladder.
The effect on unborn children was due to women who took the drug during their pregnancy. Due to the greater harm Topamax caused, the United States Food and Drug Administration began advising doctors to issue the strictest caution to patients when prescribing the drug. A statement telling of the great risks Topamax exposed pregnant women and their unborn children to, was also released by the USFDA in March of 2011.
Besides the severe harm to unborn children, Topamax was also found to cause other, more ordinary, side effects, including nausea, loss of appetite, diarrhea, dizziness, fatigue, speech problems, coordination problems, vision and sensory distortion, difficulty with concentration and memory retention, which causes some people to experience memory recall issues, changes in taste (food and carbonated drinks), numbness and tingling, which is more commonly known as paresthesia, a numbness in the arms and /or legs which many describe as “pins and needles,” and others.
Once affected by Topamax, any deformity in the unborn child could be irreversible. Upon birth, however, surgical procedures may be performed to correct whatever the defect is. Surgery and other required treatments, though, are expensive. This is where the moral and legal obligation of the manufacturer of Topamax ought to be taken into account. Legally speaking, its manufacturers may be required to compensate those who can prove their child’s deformities were directly caused by Topamax.
Despite being effective, there are many recorded Topamax side effects and some of these are definitely serious. If you want to know what your legal rights are as a victim, going to a highly competent Topamax lawsuit attorney would be a commendable move.Learn More
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.Learn More