Here is a core dilemma that greatly concerns drug regulators and undercuts adequate testing of medications to determine their potential risks to pregnant mothers or unborn children: Testing absolutely must be done on the relevant population to secure hard data, yet organized studies present stark ethical issues that preclude such research. The result is that birth injuries or defects that stem directly to a mother's use of a particular prescription drug are only discovered following public release of the drug and the accumulation of evidence over time and though multiple instances that the drug is causing birth injuries.

Such has been the case with the anticonvulsant drug Topamax, which is frequently used as a migraine medicine. The FDA release d a safety alert last month concerning the drug, with investigators stating that "there is positive evidence of human risk based on adverse reaction data from investigational or marketing experience or studies in humans."

What that means: Evidence has emerged that shows Topamax use by a pregnant woman increases comparatively the risk of a newborn baby having an oral-facial deformity such as a cleft lip or cleft palate. The chance of such an outcome is about nine times higher for women who used the drug during pregnancy than for those who did not.

The FDA has thus reclassified Topamax as a category D drug, with the agency advising women to explore all other options before using such a drug during pregnancy.

Persons with questions or concerns regarding the use of Topamax during pregnancy should contact an experienced medical malpractice trial attorney who practices regularly in the area of birth injuries.

Related Resource: Digital Journal, "Following Wall Street Journal Report on Birth Injury from Prescription Medications, RX Birth Defects Releases New Resources for Alleged Victims of Topamax" April 12, 2011