FDA says migraine drug hikes the risk of oral birth defects

New data shows pregnant women taking the drug sold generically and by Johnson & Johnson as Topamax are around 20 times more likely to have their babies develop cleft lips or cleft palate deformities than those who are not taking the drug, the Food and Drug Administration (FDA) said.

Warn pregnant patients about the risks
The oral birth defects occur in the first three months of pregnancy. This is the period women are least likely to know they are expecting. So the FDA officials called on doctors to warn their female patients of childbearing age who are taking the drug about the risks of giving birth to babies with oral birth defects.

Russell Katz, who heads the FDA’s Division of Neurology Products, said doctors should be careful before prescribing the drug to patients of childbearing age and "alternative medications that have a lower risk of birth defects should be considered."

The FDA issued warning based on the data collected from the North American Antiepileptic Drug Pregnancy Registry.

Data findings
The data revealed that cleft lips or palates occurred in 1.4 percent of babies exposed to Topamax or its generic versions. When compared to mothers who are taking other drugs for epilepsy, the percentage of babies born with cleft lips or palates was between 0.38 and 0.55. only about 0.07 percent of babies had the defect whose mothers are not on any such medication.

Reacting to the latest warning by the FDA, J & J said in a statement, Topamax’s label already notes the risks associated with pregnancy, and recommended its cautious use for pregnant patients. It said it would work with the FDA to clarify the use of the drug during pregnancy.

Topamax
Topamax is one of the high revenue-grossing drugs for the J & J. At its peak in 2008, the drug brought in more than $2.7 billion. Later on the other generic versions arrived.

Teva Pharmaceutical Industries Ltd, Watson Pharmaceuticals Inc Mylan Inc and other generic drug makers also sell the drug under its chemical name topiramate.

For 2010, Topamx is expected to fetch $569 million worldwide.

Oral Birth defects
Oral birth defects like cleft lips and cleft palates are very rare in U.S. They occur before the mouth of the child fully forms, and probably in the first three months, causing a split lip or a hole in then palate.

The cleft lips and cleft palates make it hard for babies to get adequate food and necessary nutrition. These can be corrected with surgery but it sometimes takes multiple operations to get the shape of the mouth and lips to normal.