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

Topiramate Warning Update – A Medical Ethics Dilemma?

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What is Topiramate? Topiramate is an antiepileptic drug (also used to prevent migraine headaches). The drug targets the specific types of seizures that people with epilepsy suffer. Recent data has placed a new burden on these patients already suffering with a significant problem (seizures or migraine headaches). Now, any one of these patients who is or may become pregnant needs to be made aware of the risks to the unborn infant. It is creates a very difficult situation, choosing between their own health and the health of the unborn. This dilemma raises not only medical health issues but also medical ethics issues.

An Ethical Dilemma: I would like to explore these health and ethics issues so that you may weigh in on how you would go about choosing between protecting your own health and that of the unborn (soon to be born). On the one hand, is the fact that a mother needs to remain healthy, and perhaps seizure free in order for her to reach full term with the pregnancy. On the other hand, use of topiramate during the first trimester may cause irreparable harm to the fetus, resulting in an infant with a cleft lip, or cleft palate – oral palate injuries. On the one hand it is dangerous to the mother to not take the drug and on the other hand it is dangerous to the fetus to continue to take the drug. What would you choose?

A Medical Dilemma: What is a doctor to do? What should doctors tell their patients about these risks? Doctors have a duty to inform patients, and this is an important responsibility. Doctors need to warn patients of childbearing age about the possible dangers to the fetus if she becomes pregnant while taking Topamax and to discuss alternatives. And any woman thinking about becoming pregnant can consider with her doctor whether there are safer alternative treatments.

Where There is No Dilemma: When it comes to the manufacturer of Topamax, the name brand of topiramate, there is no dilemma. They needed to warn the public, and especially doctors, of this unique increased risk of their drug. Topamax has been available for many years. It has been around so long that it is now sold generically by other manufacturers under the generic name topiramate. Doctors with this data can offer to their patients informed risk-benefit choices about the use of this drug or others.

The manufacture had a duty to study the data that revealed that will over1 out of every 100 mothers who took Topamax had infants with oral clefts, as opposed to an incidence of 0.38 percent – 0.55 percent for infants whose mothers took other antiepileptic medications. That is well over double the risk. The manufacturer had a duty to warn and failed to do this in time for so many infants now suffering with a cleft palate. This information should have been given to the doctors years ago.

If you were faced with this dilemma, what would you choose?