Were Patients Adequately Warned About Topamax Side Effects?

Dallas, TXOne of the main questions involving Topamax birth defects allegations is whether or not patients were adequately warned about the risk of Topamax side effects, specifically, the risk of Topamax birth defects. Women who took Topamax during pregnancy allege that Topamax had an impact on their infants, resulting in birth defects known as oral clefts.

In cases where drug side effects are alleged, the issue becomes whether or not patients were adequately warned about those side effects and if, had they known about the potential side effects, patients would still have taken the medication. Topamax is approved to treat epilepsy and migraine headaches. Recent studies, however, suggest that use of the medication while pregnant is linked to an increased risk of cleft lip and cleft palate, known together as oral clefts.

Compared with the birth defects linked to other medications, oral clefts might not seem overly serious. But the truth is that although oral clefts are not life threatening, they can have a serious impact on patients throughout their life. Many patients born with oral clefts require repeated surgeries as they grow and their jawbone develops. They may undergo various therapies and experience repeated infections. They often have to see ear, nose and throat specialists, surgeons, speech therapists, dentists and orthodontists to help them recover.

No lawsuits have been filed so far against the maker of Topamax, although the drug has been raised from FDA Pregnancy Category C to Category D, meaning that studies in humans show a potential risk to infants.

A study recently published online in the journal: BJOG: An International Journal of Obstetrics & Gynaecology (05/11/11) found that women who had epilepsy and used an antiepileptic medication were at an increased risk of bleeding in early pregnancy, induction and eclampsia. The same women were also at an increased risk of having babies with malformations.

That study was in addition to one published in the Journal of the American Medical Association that found that women who used certain antiepileptic drugs during the first trimester were more likely to have a baby born with a major birth defect, compared to women who did not use an antiepileptic medication.

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