Migraine medication linked to cleft palate birth defect

Migraine Medication Linked to Cleft Palate

Migraine medication Topamax (generic name: topiramate), which is also indicated for epileptic disorders, have been linked by health experts from the Food and Drug Administration to an increased likelihood of cleft palate in babies.

An examination of new records shows that mothers who use the migraine medication ups their risk of having babies with cleft palate or cleft lip by about 20 times than normal.

The agency's chief of the Division of Neurology Products Russell Katz warned physicians about prescribing the drug to patients and that "alternative medications that have a lower risk of birth defects should be considered."

Women of childbearing age who are taking the migraine medication should be forewarned of the risk because these birth defects develop in the first three months of pregnancy, when they are often unaware that they are pregnant.

Besides disfiguring the babies' face, cleft lips and cleft palates also lead to malnutrition and other developmental problems. These birth defects can be surgically repaired.

The health agency based its announcement on data from the North American Antiepileptic Drug Pregnancy Registry, which showed that 1.4 percent of babies whose mothers used Topamax had cleft lips or palates versus just 0.38 to 0.55 percent when using other drugs in its class.

Topamax is projected to generate $569 million in global revenue for its manufacturer Johnson & Johnson this year. The company said its product has existing pregnancy risk warnings on its labels which "recommended cautious use in pregnant patients." Originally marketed as an anticonvulsant, Topamax is usually prescribed as an epileptic and migraine medication.

Posted by George Daniels on Saturday March 05 2011, 5:09 AM EDT. Ref: Reuters. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0