In a novel study US health regulators warn that expectant mother taking Topamax known as epilepsy drug and are also used to prevent migraine are at higher risk of delivering babies having oral birth defects. The oral birth defects generally occur in first three months.
The statistics of new study shows that pregnant women taking migraine drug are twenty percent more prone to have their babies develop cleft lips in comparison to those not taking the drug, state the FDA (Food and Drug Administration). In initial three months women are least prone to know that they are expecting.
Oral birth defects such as cleft lips and cleft palates are very uncommon. They happen prior to the mouth of the baby forms fully and about surely in the first three months, causing a split lip. These oral defects make it hard for babies to get sufficient food and essential nutrition.
These oral defects can be corrected with surgery but sometimes it takes several operations to make the shape of the mouth and lips normal. Therefore FDA watchdogs called on doctors to warn women patients of childbearing age taking the drug about the risk of giving birth to babies with oral defects.
The warning issued by FDA is based on the statistics composed from the North American Antiepileptic Drug Pregnancy Registry. It is found through statistics that cleft lips or palates occurred in one and half percent of babies exposed to Topamax, while it was .38 and .55 percent those exposed other epilepsy drugs.
In response to latest warning by FDA, Johnson and Johnson explained in statement that Tpamax’s labels already notes the risks linked to pregnancy and recommended its careful use for pregnant women and it would work with FDA to elucidate its use drug during pregnancy.
According Russell Katz, head of the FDA’s Division of Neurology Products, doctors should be cautious before prescribing the medicine to women of childbearing age and substitute drugs which have lower risk of birth defects should be prescribed.