Mothers who have given birth to infants with cleft palates for the last 15 years are urged to recall if they have ever taken the anticonvulsant drug Topamax during their pregnancy because this may have contributed to the birth defect. Recent studies suggested that infants born of mothers who took Topamax during pregnancy are at an increased risk of developing birth defects especially oral clefts early in the first trimester. Added to the Topamax side effect is Hyperammonemia, however, the birth defects remain as the most serious side effect that researchers have discovered.

A mother and child go through a lot through the stages of pregnancy both physically and emotionally. A mother would make sure she has the proper diet and exercise, among others, as she would do anything to ensure her baby’s health even while still inside her womb. To make a mother choose between her health and that of her baby is very unfair because getting pregnant takes a lot of planning. Ironically, it is good that she is given the dreadful choice now because 15 years ago, this was certainly not the case.

{Topamax is manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson, and was approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy in 1996 and indicated for the prevention of certain types of migraine headaches in 2004. | The US Food and Drug Administration (FDA) approved Topamax, manufactured by Johnson & Johnson subsidiary Ortho-McNeil, for epilepsy treatment in 1996 and indicated for the prevention of certain types of migraine headaches in 2004. | In 1996, Topamax, manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson, was approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy; and in 2004, it was indicated for the prevention of certain types of migraine headaches.

Everything has been going well for the anticonvulsant considered as one of the widely prescribed drug for both conditions until studies began in the United Kingdom and the US thereafter suggested its association with birth defects.

The FDA issued a warning March this year and elevated Topamax’s classification from pregnancy category C to D, validating the findings, after 15 years have passed since it was given the stamp of approval.

Never knowing that they themselves were putting their babies at risk, one could just imagine the number of pregnant women who had taken Topamax in the last 15 years. Causing difficulty in eating and in talking, as well as ear infections, a Topamax cleft may range from a small notch in the lip to a groove which extends into the palate. Growing up being ridiculed for having a facial deformity could be the worst problem a baby with a cleft palate would have.


To have a chance at a normal life, an infant with a cleft palate may have to go through corrective surgery. A cleft palate lawsuit is an option for affected families to be able to seek compensation for medical expenses incurred due to the birth defect.

 In the medical world, it is a fact that one medicine can be answer to more than one medical condition. Although they are developed to be potent for a certain condition, due to the different chemicals involve in making them, they can be used to treat other conditions too. The danger and number of the side effects present on a certain product might be explained by this. Topamax’s current situation can be given light by this explanation.