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What parents of children with birth defects should know about Topamax

4 comments

Topamax (generic name “topiramate”) is one of a class of medications known as “anticonvulsants.” According to the approved FDA label, Topamax is “indicated for” meaning approved for use by the FDA for:

  • 1. Epilepsy – for seizure control
  • 2. Lennox-Gastaut syndrome – to control seizures caused by this syndrome (approved 2001)
  • 3. Prevention of migraine headaches – prevention only, not to relieve pain of migraine headaches when they occur

In the real world, Topamax (topiramate) is also used “off label” meaning doctors prescribe the drug for uses not approved by the FDA. This is legal. However, it is not legal for the manufacturer to promote sales of the drug (for example, advertising) for these “off label uses.” In fact, in May 2010, Ortho-McNeil Pharmaceutical LLC pleaded guilty to illegal promotion of Topamax and was sentenced to pay a criminal fine of over $6 million. Topamax has been used for neuropathic pain, anger control, post-traumatic stress disorder (PTSD) associated nightmares, metabolic diseases like adiposopathy, self injurious skin pricking, essential tremor, cluster headaches, and alcoholism.

Before March 2011, Topamax (topiramate) was a pregnancy category C drug. This means that studies on animals suggested risks to the fetus in human pregnancy but there was not enough information from human studies to prove an increased risk in humans. However, these animal studies are a signal to the manufacturer that there may be a danger of birth defects if Topamax is given to pregnant women. Once a drug is on the market, the manufacturing company has the primary responsibility to do follow up studies on signals of risks. Physicians are cautioned about the use of Pregnancy Category C drugs in the former label by suggesting Topamax should not be used in pregnancy unless benefits outweigh the potential risks. Unfortunately the manufacturer did not provide any data in humans on what that risk was. If there was a failure to warn children who suffered cleft palate and cleft lip and their families may have the right to bring a claim for the defects and the cost and suffering associated with the surgeries necessary to repair the problems. Families with an interest should contact an experienced attorney who is investigating this kind of case.

In March 2011, the FDA changed the Topamax (topiramate) to a pregnancy category D, reporting that data from registiries indicates infants exposed to Topamax before birth had an increased risk for cleft lip and cleft palate also known as oral clefts. The FDA approved label now warns doctors to consider the risks and benefits of Topamax before prescribing it for women of childbearing age, especially if the prescription is for a condition not usually associated with permanent injury or death (for example, migraine headaches). The new information for doctors gave the increased risks in humans so doctors could now assess the risks. For oral clefts, the increased risk was more than 3 times the background rate for women taking other antiepilepsy medications or over 300% (1.4% versus 0.38% – 0.55%) and over 20 times the background rate of mothers who were not taking epilepsy treatments. (1.4% versus 0.07%). There is another registry in England which showed very similar results.

4 Comments

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    Birth defects are not limited to cleft palates, but also may include cranial deformation, enlarged kidneys, and holes in the heart muscle.

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    @Kevin, You are right – there are a number of birth defects associated with this entire class of drugs. Thank you for pointing out these others.

  3. LRose says:
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    I am a woman of child-bearing age, and have been since I started taking this drug for migraines over 5 years ago. I was never warned of this particular risk by either of the two doctors who have continued to prescribe it to me. Just yesterday, I saw an ad about the link between Topamax and birth defects, and I am angered and appalled at the thought of what could have happened had I gotten pregnant at any point while taking the drug. I understand drug companies not wanting to call attention to a drug’s potential risks, but where do we draw the line? Physicians should be making patients well aware of the risks before prescribing drugs like this, especially when those patients fall into a high-risk category.

  4. James Ronca says:
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    In response to the comment by LRose, it is frightening indeed to find out the risk after you have been exposed to the danger. Cleft lip and cleft palate are serious birth defects requiring several surgeries form infancy through childhood and are a terrible strain on the families whose children are effected by it.
    new drugs always have unknown dangers. While many call for smaller government, in some areas we need more. The FDA should regulate these things more closely. Right now, the most important way in which information about who knew what and when come form individuals filing lawsuits so their lawyers cna use the courts’ subpeona power to find out. Right now the only real check on most drug companies is the fear of lawsuits. (Some companies are legit and thical on their own.) Sometimes the only way to get the truth is through the efforts of a willing client and a lawyer willing to go out on a limb and take a lot of risk.