InsaneJournal

Birth Defects, the Most Serious Topamax Side Effect Discovered
There have been many reported side effects of Topamax, however, the 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 forming a Special Regulatory and Compliance Oversight Committee.

What makes it more ominous is 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 1996. 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. Among the birth defects associated with Topamax (Topiramate) are:

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

The US Food and Drug Administration (FDA) validated the findings by issuing a warning March this year and elevating 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."

Among the list of birth defects associated with Topamax, infants are said to be most susceptible to oral clefts. A Topamax cleft may range from a small notch in the lip to a groove which extends into the palate and may cause difficulty eating and talking, as well as ear infections. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry shows that 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. The risk of these oral cleft birth defects was much lower at 0.07 percent among infants of mothers who did not take epilepsy drugs during pregnancy.

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


Related Article:
FDA Releases New Info on Topamax's Increased Risk for Cleft Palate (jameriter.wordpress.com)