Topamax and Birth Defects - Consumer Justice Foundation

Topamax and Birth Defects

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Topamax and Birth Defects

Women who take the anticonvulsant drug Topamax while pregnant may have an increased risk of giving birth to children with serious birth defects.

As more and more patients are diagnosed with epilepsy and other seizure disorders, the amount of Topamax prescriptions filled by consumers is climbing. Topamax entered the market in 1996 as a treatment for partial onset and generalized tonic-clonic seizures resulting from epilepsy, and was additionally indicated for migraine headache prevention in 2004. Since that time, women of childbearing age all over the country have taken Topamax to relieve their migraines, a condition that affects this population more than any other in the U.S. Unfortunately, the fact that the anticonvulsant drug Topamax (topiramate) may be associated with major birth defects when taken in pregnancy has prompted the FDA to advise against use of this medication by women of childbearing age. Even if female Topamax patients who fall into this category don’t plan to become pregnant, taking the anticonvulsant drug may still be dangerous, as nearly half of all pregnancies in the United States are unplanned. If you became pregnant while taking Ortho-McNeil Pharmaceutical’s Topamax and your child was born with a serious birth defect, contact a qualified birth defect attorney for help.

Birth Defects Possibly Linked to Topamax

There are enough things that an expectant mother has to worry about during pregnancy; the adverse effects of your medications shouldn’t be one of them. Unfortunately, without adequate information about the side effects of certain pharmaceutical drugs, consumers are unable to make informed decisions about which medications are safe for them to take and which aren’t, especially during pregnancy. Babies who are exposed to the epilepsy drug Topamax in pregnancy, for example, may have an increased risk of being born with serious birth defects like cleft lip, cleft palate and a genital malformation called hypospadias. In fact, according to FDA warnings concerning Topamax birth defects, the risk of oral clefts in children exposed to Topamax in utero is nearly twice that of children not exposed to any anticonvulsant drugs during pregnancy. This information led the FDA to increase the pregnancy category of Topamax from C to D in March 2011, which means there is positive human evidence of the drug’s potential to interrupt fetal developmental and cause major birth defects.

One of the most difficult decisions a pregnant woman must make regarding her safety and the safety of her child during pregnancy is to weight the benefits and risks associated with her anticonvulsant medication. Topamax may reduce the incidence of seizures and relieve other symptoms of epilepsy, but at what cost? Studies have shown that the well-being of an unborn child may be compromised upon exposure to anticonvulsant drugs like Topamax, which is why the FDA has advised physicians to avoid prescribing the medications to women of childbearing age, especially for conditions not typically associated with permanent injury or death.

How to Prevent Birth Defects in Pregnancy

The first step to take in lowering your child’s risk of being born with a birth defect is to talk to your doctor. It is the responsibility of physicians, surgeons and Ob/Gyns to provide you with accurate and up-to-date information about medications, especially if you are pregnant or planning to become pregnant. It is important that women taking anticonvulsant drugs like Topamax discuss with their doctor the potential risks associated with that particular medication, and perhaps even consider alternative treatment options. Research indicates that one in every 33 babies is born with a birth defect. This staggering statistic should be enough to bring public attention to the matter and spur immediate action, which may be as easy as simply helping consumers stay informed about anticonvulsant drug birth defect risks. If your baby was born with a serious birth defect and you believe Topamax to be the cause, contact a birth defect attorney to discuss your legal options.

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