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Topamax Linked to Cleft Palate, Cleft Lip and Other Birth Defects

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New research indicates that the use of the epilepsy and migraine drug Topamax, either on its own or in combination with other epilepsy drugs, may increase the risk of birth defects when it is used during pregnancy. A small study found much higher than expected incidences of babies born with cleft lips, cleft palates, genital defects or other birth malformations among women using the drug.

The findings are reported in the July 22, 2008 issue of Neurology, the medical journal of the American Academy of Neurology (AAN). Researchers at the Royal Group of Hospitals in Belfast, Northern Ireland, followed 203 women who were pregnant while taking topiramate, which is available as a generic or under the brand name Topamax.

Women included in the study were epileptics taking either Topamax alone or Topamax in combination with another epilepsy drug. Of the 178 babies born, 16 had major birth defects. Mothers of three of these infants were taking only Topamax while in the remaining 13 cases the mothers were taking Topamax along with other epilepsy drugs.

Four of the babies were born with cleft lips or palates, which is a rate 11 times higher than what would be expected in the general population. Cleft lip and palate is a congenital deformity caused by abnormal facial development during gestation, where cartilage does not fuse correctly. Often the birth defect can be treated with surgery, but it may cause problems with feeding, ear disease, speech problems and difficulty with socialization as the child ages.

Four of the male babies born to women in the study were found to have genital defects, which is a rate 14 times higher than what would be expected in the general population. Two of these babies were diagnosed with hypospadias, in which the opening of the urinary tract is not at the tip of the penis.

Topamax is manufactured by Ortho-McNeil Neuologics, a subsidiary of Johnson & Johnson. When it was first introduced, it was only approved by the FDA for treatment epilepsy, which is a neurological disorder characterized by recurrent uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating severe headaches known as migraines. It is also used off-label by many doctors to treat bipolar disorder. Generic forms of the drug began to appear in 2006.

“More research needs to be done to confirm these results, especially since it was a small study,” said John Craig, MRCP, of the Royal Group of Hospitals. “But these results should also get the attention of women with migraine and their doctors, since topiramate is also used for preventing migraine, which is an even more common condition that also occurs frequently in women of childbearing age.”

Although the study only involved women with epilepsy, it does raise concerns about the overall risk of Topamax birth defects. Topamax has become one of the most widely prescribed migraine medications in the United States, and women generally suffer from migraines three times more often than men.

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6 comments

  1. Pingback: Topamax Lawsuits — AboutLawsuits.com

  2. Lisa Reply

    I fell pregnant in February 2007, I was prescribed topamax in December 2006. Following my 32 week scan it was discovered that my baby has a bi-lateral cleft lip and palate, Josh was born in November 07 and has the first of his corrective surgeries. He is fine and full of beans, but to think this could have been avoided if it weren’t for my medication is quite chilling!

  3. Sherri Reply

    I took Topamax for approximately 12-14 days approximately October 2008. I discontinued the medication after speaking with the pharmacist and my doctor. My side effects while on the medication were extreme confusion and lack of ability to produce words, dizziness, forgetfullness, eye pain and the inability to perspire. I am also diabetic and one of my warning signs of my blood sugars being abnormal is the change in my body with perspiration. To this day, I still have occasions of inability to form or “find” words, and have not returned to having the ability to perspire. This is a serious concern of mine due to health issues and complications thereof.

  4. brook Reply

    i just had my 20 week scan i am having a little princess but not ptrepared for them to tell me she has a left pallet i have been very upset everyone keeps saying that its nothing but a shock as its my first baby its not fair.

  5. haley Reply

    when i found out i was pregnant i was about 6 weeks into the pregnancy. my doctor told me to wean myself off of topamax. i found out when i was 27 weeks that my son had a cleft palate, which is formed by the time a mother is 8 weeks pregnant. hes had one surgery & still has 2 more. im now expecting again and hoping this baby doesnt have to go thru the same thing as my 19 month old did. why are things like this even out there when they can cause so many side effects especially to an innocent baby.

  6. John Reply

    My wife was on Topamax in 1998 after the birth of our daughter she then fell pregnant while on this medication, When we found out she was pregnant we told her neurologist asap. He took her off that medication straight away, which at that time i thought was very unusual as they usually reduce a medication to remove it from an epileptic. Our son was born with a server cleft lip and palate with ASD as well. I tried to seek help here in Australia when I found out about this information, i have been told i would need to find more families affected by Topamax in Australia. I have not had any luck doing so.

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