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Study shows link between epilepsy drug Topamax and birth defects in newborns

topamax134A study published in the medical journal Acta Neurologica Scandinavica suggests a link between epilepsy drug Topamax and birth defects in newborns.

The authors of the study, a group of Australian doctors, found a statistically significant relationship between a pregnant woman’s use of Topamax (topiramate) and the likelihood of hypospadias (genital defects) and brain defects in infants, according to the study.

Another study that provides hard evidence of the alleged side effects of Topamax, about which the FDA has issued warnings including those that deal with developmental defects in infants.

In 1996, the U.S. Food and Drug Administration approved Topamax, manufactured by Johnson & Johnson subsidiaries Ortho-McNeill and Noramco, Inc. In addition to epilepsy, the drug is also prescribed for Lennox-Gastaut syndrome, migraine headaches and bipolar disorder and to prevent weight gain for those on antidepressants. This is in addition to several other uses.

From FDA website:

Topamax (topiramate): Label Change – Risk For Development of Cleft Lip and/or Cleft Palate in Newborns

Available as generic topiramate 

AUDIENCE: Neurology, OB/GYN

ISSUE: FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

BACKGROUND: Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

Source: Multiple

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3 Comments

  1. I was prescribed Topamax for weight loss a couple of years ago and I took it for a week or two and didn’t like the way it made me feel so I stopped, I was working in the oil industry 70 to 80 hours a week and had the first seizure out of town working and I’ve been having seizures ever since, I can’t even feel the seizures coming on, I could be standing and having a conversation with someone and start seizing I’ve seen three neurologists and they still haven’t been able to get the seizures under control and I had never had a seizure in my life before I was placed on Topamax for weight loss

    Reply
  2. Profile photo of

    I have Epilepsy. One day was prescribed Topamax. Stayed on it for 6 months and it significantly lowered my cognition, increase short term memory loss–I mean seconds-GONE! Hair fell out , needed anger mgmt, problems with language. It felt like I was translating English in my head but English is the only language I really speak! Crazy! To this day, you cannot speak too quickly to me. Lost my ability to teach after 17 years. Now, I just don’t have the will. So. . .going back to school and trying for med tech. wish me luck!

    Reply
    • Profile photo of

      oh yeah (forgot) you should not suddenly stop taking Topiramate/Topamax because it can cause seizures. Marquis keep shopping for a neurologist I learned some really give a damn if you’re falling out.

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