Because it may have contributed to having their infants born with the birth defect cleft palate, mothers are urged to recall if they have ever taken the anticonvulsant drug Topamax during their pregnancy for the last 15 years. Mothers who take Topamax during pregnancy are increasing the risk of their babies in developing birth defects especially oral clefts early in the first trimester, according to recent studies. Hyperammonemia is another Topamax side effect; however, the birth defects remain to be the most serious side effect ever discovered by researchers.
A mother and child go through a lot through the stages of pregnancy both physically and emotionally. A mother would do anything to ensure her baby’s health even while still inside her womb by making sure she has the proper diet and exercise, among others. To make a mother choose between her health and that of her baby is very unfair because getting pregnant takes a lot of planning. Fifteen years ago this was certainly not the case, as dreadful as it might be, ironically, it is good that she is given the choice now.
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.
Topamax has been considered as one of the widely prescribed drug for both conditions and everything has been going well for the anticonvulsant 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.
In the last 15 years, one could just imagine the number of pregnant women who had taken Topamax never knowing that they themselves were putting their babies at risk. Ranging from a small notch in the lip to a groove which extends into the palate, a Topamax cleft palate may cause difficulty eating and talking, as well as ear infections. Growing up being ridiculed for having a facial deformity could be the worst problem a baby with a cleft palate would have.
An infant with a cleft palate may have to go through corrective surgery to have a chance at a normal life. 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.
