Birth Defects Discovered As Most Serious Topamax Side Effect

Of the many reported side effects of Topamax, birth defects are said to be the most serious side effect discovered by far. Topamax is manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson (J&J), for the treatment of epilepsy and prevention of certain types of migraine headaches. The Topamax birth defects are the least of the giant pharmaceutical’s problems with J&J formed a Special Regulatory and Compliance Oversight Committee.

The fact that Topamax’s potential to cause harm among infants whose mothers were prescribed the drug during their pregnancy were only made public this year, 15 years after it was first marketed in 1996, made it more ominous. The findings were the results of several studies in the US, and supported by similar data from the United Kingdom Epilepsy and Pregnancy Register which was published in 2008 in the journal Neurology. The birth defects associated with Topamax (Topiramate) are:

* arm and limb defects
* brain defects
* cleft lip
* cleft palate
* heart defects
* Hypospadias
* lung defects

The findings were validated when the US Food and Drug Administration (FDA) issued a warning March this year and elevated the classification of Topamax from pregnancy category C to D. “Health care professionals should carefully consider the benefits and risks of Topiramate when prescribing it to women of childbearing age,” Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, says in a statement. “Alternative medications that have a lower risk of birth defects should be considered.”

It has been said that infants are most susceptible to oral clefts among the list of birth defects associated with Topamax. Ranging from a small notch in the lip to a groove which extends into the palate, A Topamax cleft may cause difficulty eating and talking, as well as ear infections. About 1.4 percent of infants exposed to Topiramate during pregnancy developed cleft lip or cleft palate, compared with 0.38-0.55 percent of infants exposed to other epilepsy drugs, according to the data from the North American Antiepileptic Drug (AED) Pregnancy Registry. Much lower at 0.07 percent was the risk of these oral cleft birth defects among infants of mothers who did not take epilepsy drugs during pregnancy.

It is not, however, advisable to immediately stop taking the drug without consulting a healthcare professional despite the seriousness of these Topamax side effects. Doing so may put both mother and child at risk of other causes.

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