Are you pregnant and taking Topamax? The FDA Warns This Could be Dangerous for Your Child

Topamax, used to treat a broad range of ailments, poses a considerable risk to pregnant mothers who take the drug.

Since its debut in 1995, Topamax has been prescribed “to more than 4 million patients,” including pregnant women. It is classified as a Pregnancy Category D medication, which means that it “may cause harm to your unborn child.” (E Med TV)  Medications that are classified as Category D “pose a risk to a developing fetus,” (E Med TV) especially when taken during the first trimester. The most common birth defects are cleft palate (when the roof of the baby’s mouth does not develop normally) and cleft lip (a physical split or separation of the two sides of the upper lip).

Cleft lip/ cleft palate “affect one in 700 babies annually and is the fourth most common birth defect in the United States.” (Medicine Net) They tend to occur in babies of “Asian, Hispanic or Native American descent,” (Medicine Net) though the reason why these ethnicities are more prone to cleft deformity is not quite known. “Compared with girls, twice as many boys are born with a cleft lip, both with and without a cleft palate.  Compared to boys, twice as many girls are born with a cleft palate and no cleft lip.” (Medicine Net)

If my baby is born with a cleft deformity, can it be corrected?

Yes. If your child is born with a cleft deformity, it can be reversed through surgery, which can be distressing for both you and your child. Fortunately, “most children can have their cleft deformity successfully corrected within the first 12-18 months of life,” (Kids Health) although there are some exceptions, depending on the severity of the cleft deformity.

Cleft Palate Surgery: “Repair of a cleft palate requires multiple surgeries of the course of 18 years. The first surgery to repair the palate will occur when your baby is between 6 and 12 months old. The initial surgery will create a functional palate, reduce the chances that fluid will develop in the middle ears, and will aid in the proper development of the teeth and facial bones.” (Medicine Net)

Your baby “may also need a bone graft when he is about 8 years old to fill in the upper gym line so that it can support permanent teeth and stabilize the upper jaw. About 20% of children with a cleft palate require further surgeries to help improve their speech.” (Medicine Net)

Cleft Lip Surgery:  Cleft lip is more visible than cleft palate and is divided into four types:

Unilateral incomplete cleft: Located on one side of the lip and does not extend to the nose.

Unilateral complete cleft: Located on one side of the lip and extends to the nose.

Bilateral incomplete left: Occurs on both sides of the lip but does not extend to the nose.

Bilateral complete cleft: Occurs on both sides of the lip and extends to the nose.

Regardless of type, a cleft lip can lead to “feeding difficulties, middle ear fluid buildup, hearing loss, dental abnormalities and speech difficulties,” (Kids Health) although these tend to be worse in children with cleft palates.  In addition to aesthetic improvement, surgery can help your child “eat, speak, hear and breathe better.” (American Society of Plastic Surgeons)

Note: It is encouraged that you direct any questions regarding cleft deformity surgery to a licensed medical professional.

What legal options are available to me?

Weitz & Luxenberg can help you secure compensation that can cover the costs of any on-going treatment needed for your child. Please fill out the form on this page so that we can provide you with a free legal consultation. Once you have submitted the form, we will contact you within 24 hours.

Acknowledgements:

Revolution Health: www.revolutionhealth.com/articles/types-of-cleft-lip/ug1359

Kids Health: www. kidshealth.org/parent/medical/ears/cleft_lip_palate.html#

Medicine Health: www.medicinenet.com/cleft_palate_and_cleft_lip/page4.htm

American Society of Plastic Surgeons: www.plasticsurgery.org/reconstructive-procedures/cleft-lip-and-palate.html

E Med TV: www. epilepsy.emedtv.com/topamax/topamax-and-pregnancy.html

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see also:

Topamax & Pregnancy Weitz & Luxenberg Provides Information on the risk of birth defects if you take Topamax
If you takeTopamax during pregnancy, there is a chance that it could cause birth defects. Weitz & Luxenberg is here to help you file a lawsuit.

Topiramate Recall? Topiramate is still not recalled despite FDA’s warning about birth defects
There has been no Topiramate recall, but the FDA warns that use of Topiramate (Topamax) during pregnancy can lead to birth defects including cleft palate.

Topamax Side effects of Topamax include birth defects: FDA takes action
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