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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Weight loss drug with topiramate? Safety concerns for Cleft Palate used During Pregnancy.

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Earlier this year, the FDA issued new safety information related to the use of the drug Topamax (topiramate) during pregnancy, due to the increased risk of cleft lip and cleft palate birth defects, which has been observed over the last several years. The FDA’s warning signals a general agreement within the scientific and medical community that topiramate does in fact present significant risks to a fetus during pregnancy and thus requires serious consideration before its use and heightened monitoring if it is used.

The use of topiramate has traditionally been limited to the treatment of epilepsy and, occasionally, is used to treat migraine headaches. These very specific uses of the drug have meant that, while thousands of women of child bearing age are still affected, the number of individuals at risk is contained. Now, however, there is discussion of spreading the use of topiramate to the weight loss drug industry. A study that was just released in April, examined the effectiveness of a combination drug including topiramate for weight loss and metabolic risk reduction in individuals who are overweight and obese. The study, which involved nearly 3,000 participants, found that this particular drug combination might be a valuable treatment option for obesity.

While obesity is a serious a health issue that demands medical research and attention, use of topiramate to treat obesity should not be taken likely. Unfortunately, we have learned the hard way about the risks for unborn children that are associated with topiramate when used to treat epilepsy and migraines. Now, as we potentially expand the use of topiramate to address other issues, we need to remember those lessons. If topiramate ultimately receives approval for use in weight-loss drugs, the FDA needs to take a proactive stance in terms of the warnings and recommendations associated with the drug’s use.

Just as it has recently done for Topamax and its generic versions, specific warnings about topiramate’s observed connection to oral cleft birth defects need to be provided so that women, with the assistance of their physicians, can make informed decisions about treatment during pregnancy. In addition, information about the relative risks of continuing treatment with a topiramate drug versus stopping that treatment during pregnancy need to be highlighted.