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FDA Reclassifies Anti-Migraine Med Topomax For Risk of Birth Defects

The Wall Street Journal and other media outlets have recently investigated how the Food and Drug Administration (FDA) reviews and categorizes drugs that pregnant women may take: the pregnancy category classification. One drug, Topomax (also known as the generic topiramate), which is taken by migraine sufferers to prevent painful headaches and other debilitating migraine side effects has been re-categorized. Topomax is also approved as an anti-seizure medication for people with epilepsy.

The FDA issued a Med Safety Alert in which it alerted physicians and pregnant women that Topomax and its generic forms might cause cleft palettes and cleft lips in babies whose mothers used the anti-migraine drug while pregnant. Topomax has now been placed on the list of drugs categorized as Pregnancy Category D. Drugs in this FDA classification should only be taken by pregnant women after the benefits to the mother are weighed against the risks to the fetus, and no other safer option is available to the mother. Pregnancy Category D drugs have been linked to birth defects in babies, but the drugs may be the best available alternative for the mother.

FDA Has Issued Other Alerts on Anti-Convulsants and Anti-Psychotics Recently

The FDA's reclassification of Topomax is the most recent in its examination of other anti-convulsants and anti-psychotics that might be taken during pregnancy. Anti-seizure drug Depakote is another example of an anti-convulsant that has been linked to birth defects - specifically spina bifida. Anti-psychotics such as Ability, Haldol, Zyprexa and others have also been linked to serious birth defects.

Because of the ethical issues surrounding drugs and clinical trials that test the safety of prescriptions for pregnant or nursing women and their babies, the FDA has no comprehensive review process to determine whether a drug might have risks to a fetus in utero. Almost all drugs that are linked to birth defects are discovered after the drug is released on the market. For that reason, many families discover that their child has been harmed by a prescription that the mother took while pregnant before the FDA or other prescription drug registries are even aware of the drug's link to birth defects.

If your child was born with a birth defect that you suspect is linked to a prescription drug that you took while pregnant, contact an experienced birth injury lawyer to discuss your legal options.

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