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What do families need to know about the use of Topamax or Topiramate?

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Should women who may be or are pregant worry about the drug Topamax or the generic version Topiramate? I think so. as reported in the well respected science site MDLinx about a paper in The Journal of the American Medical Association (JAMA) earlier this year:

Newer-Generation Antiepileptic Drugs and the Risk of Major Birth Defects JAMA, 05/19/2011

Mølgaard–Nielsen D et al. – Among live–born infants in Denmark, first–trimester exposure to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam compared with no exposure was not associated with an increased risk of major birth defects.

Methods

  • Prevalence odds ratios (PORs) of any major birth defect diagnosed within the first year of life by fetal exposure to antiepileptic drugs.

Results

  • Of the 1532 infants exposed to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam during the first trimester, 49 were diagnosed with a major birth defect compared with 19 911 of the 836 263 who were not exposed to an antiepileptic drug (3.2% vs 2.4%, respectively; adjusted POR [APOR], 0.99; 95% confidence interval [CI], 0.72–1.36).
  • A major birth defect was diagnosed in 38 of 1019 infants (3.7%) exposed to lamotrigine during the first trimester (APOR, 1.18; 95% CI, 0.83–1.68), in 11 of 393 infants (2.8%) exposed to oxcarbazepine (APOR, 0.86; 95% CI, 0.46–1.59), and in 5 of 108 infants (4.6%) exposed to topiramate (APOR, 1.44; 95% CI, 0.58–3.58).
  • Gabapentin (n = 59) and levetiracetam (n = 58) exposure during the first trimester was uncommon, with only 1 (1.7%) and 0 infants diagnosed with birth defects, respectively.

Read this article on JAMA


As the JAMA paper emphasizes "safety data on first-trimester use of newer-generation antiepileptic drugs and birth defects are limited."

Law offices across the country are getting calls from women who were prescribed a drug called Topamax and whose baby was born with oral cleft defects. A leading authority on the subject, attormey Michael Monheit, has written extensively on this drug:

In studies Topamax caused birth defects, miscarriages, and low fetal weight when given to pregnant rabbits and mice. When Topamax was given to pregnant women, it also caused some oral cleft birth defects.

The genreric name for Topamax is Topiramate. Why is it ptrescribed and how long has it been used? Is it only for pregnant women? Is it just prescribed to women with epilepsy?

The history is laid out in PA Law Blogs:

The first generic forms of Topamax tablets, topiramate, were approved by the U.S. Food and Drug Administration (FDA) on April 1, 2009, to prevent seizures in individuals who have epilepsy. Topamax and topiramate are also approved for use to avert migraine headaches, but not to ease the throbbing of migraines. In 2009, Topamax and generic topiramate were recognized as posing potential side effects, some of which included metabolic acidosis and serious eye problems. However, it wasn’t until March 4, 2011, that the FDA announced data from the North American Antiepileptic Drug (AED) Pregnancy Registry warning of a heightened danger of cleft lip and cleft palate oral birth defects in infants whose mothers took Topamax or topiramate during pregnancy.

The Antiepilectic Drug (AED) Pregnancy Registry at Mass General Hospital is a good resource on drugs for women who may become pregnant.

Women sufferiung from migraines are often desperate for anything that will stop the headache from occuring. Doctors treating migraine are often frustrated by lack of effective treatments and many women suffer debilitating haedaches, even when taking advanced migraine medications, 3 or 4 times a month. The Topamax prescription has nothing to do with the pregnancy and the prescribing doctor is usually not the pregnancy doctor but an internist or neurologist. An important tip for everyone is to know that the doctors treating you often do not talk to each other and do not use a team approach to your health.

The FDA has issued a recent warning (March 4. 2011) to doctors prescribing Topamax or Topiramate:

"Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "Alternative medications that have a lower risk of birth defects should be considered."

A 15 year old boy I know just was prescribed Topiramate for a head injury that resulted in dizziness, memory problems and headaches. The prescribuing doctor was a neurologist. When the boy experienced nausea and loss of appetite and depression his mother spoke to their pediatrician who immediately told her to take the boy off Topamax.

Note that Topamax has FDA approval. That should alert everyone to exactly what "FDA approval" means. It does not mean that a drug is safe. It does not mean that you can use the drug for any condition or for any person. Women often do not know that they are pregnant in the first trimester. They may get Topamax for migraine and by the time they are aware of the pregnacy the cleft lip or cleft palate may already have occured.

The purpose of this article is to warn women that they should not take Topamax / Topiramate if there is any chance that they could become or are pregnant. Good doctors will carefully screen women patients for any possibility of pregnancy before prescribing. I have known women who have taken Toppamax for migraine and it is not always successful at blocking migraines. Why take a chance? Note how this video from the Pharma industry which ranks #1 on a Youtube search, says nothing about buirth defects or pregnancy:

http://www.youtube.com/watch?v=gomOKSsWokQ

You have to protect yourself and not count on getting information from the drug companies. For those women who have had a baby with cleft palte or cleft lip, and took Topamax or Topiramate during pregnacy, you may find my article on insurance issues in getting treatment for your child helpful: Tips regarding insurance for kids with cleft palate.

One of the quality resources for parents with children suffering oral cleft problems is Michael Monheit and the law firm of Anapol, Schwartz in Philadelphia. I have no connectiuon with those lawyers but I have confidence in their expertise and ethics. Hawaii residents call me frequently asking about injuries from prescription drugs or medical devices like the DePuy implants. I get nothing for referring them to any mainland lawfirms so I refer to Michael Monheit because of the quality of the legal services and his vast knowledge of the medicine on these cases.

Two other great legal resources on dangerous drugs and medical devices is Joe Suanders in Tampa, Florida at Saunders & Walker, and M. Brandon Smith in Atlanta at Childers, Schlueter & Smith, LLC. They are all brilliant lawyers with access to the latest medical and scientific information on drugs and medical devioces that injure people, particularly mothers and their children. Lawyers are in possession of the true facts about defective drugs and medical devices, and people will get information from their lawyers that the doctors and government regulators at the FDA will not disclose. It is free to talk to a lawyer to find out these facts whether or not you want to file a claim. Safety and prevention are the focus at Wayne Parsons Law Offices. I hope that families read this article, avoid taking Topamax or Topiramate if they may become or are pregnant, and avoid having a child with cleft lip or cleft palate.