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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Increased Birth Defect Risks in Two FDA-Approved Epilepsy Medications

6 comments

Two epilepsy drugs – Lamictal and Keppra – which are currently listed in category C may be dangerous to a fetus and should be listed in category D, according to new data. The difference between the categories is that D shows evidence of risk, but the benefits outweigh the risks. While category C is indicated for drugs that have shown to be harmful in animal studies.

Methodology RxFilter, a powerful database and searching tool analyzed the FDA’s Adverse Event Reporting System in regards to birth defects, stillbirths, and congenital abnormalities that were linked to 18 medications for epileptics.

Lamictal, also known as Lamotrigine, is a drug manufactured by GSK to control seizures associated with some forms of epilepsy.

Keppra (levetiracetam) is another medication used to treat seizures and adults. It is manufactured by UCB Pharma.

Other anti-epilepsy drugs examined included: Dilantin, Klonopin, Neurontin, Topamax, Trileptal, and Zonegran among others.

Birth defects are a serious adverse drug event associated with a variety of prescription drugs. The use of RxFilter indicates that the FDA’s current categorization of pregnancy risks needs revising. Regulatory bodies need to consider the need to reclassify some drugs, but at the same time more studies need to be done to provide conclusive evidence.

The FDA’s Adverse Event Reporting System (AERS) is the largest active database of adverse events, but it is incomplete, filled with misclassifications and misspellings and most importantly out-of-date. Other databases exist in the form of birth registries and there is also data that is kept by health insurance companies that can also be used to track the association between drugs and side effects.

Common Birth Defects Tied To Drugs

Cleft lip is a treatable birth defect that affects the upper lip and the roof of the mouth (palate). It happens when the tissue that forms in the roof of the mouth and upper lip don’t completely fuse together before birth. Other birth defects include spina bifida and heart defects.

Topamax, also ananti-seizure medication, in particular, is shown to increase the risk of oral clefts in infants exposed to the drug or generic rivals, during the first trimester of pregnancy. In fact, since the FDA warning in March, several Topamax lawsuits have been filed and are pending.

6 Comments

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  1. EG says:
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    Your ignorance is shocking. You incorrectly state that the FDA Adverse Event Reporting system is the only data available. There is a long-standing, prospective, national registry for antiepileptic medication related birth defects, which has multiple publications in the medical literature. Lamictal and Keppra are actually two of the safer drugs to use related to pregnancy. The website is: http://www2.massgeneral.org/aed/
    You should also be aware of the recommendations of the American Epilepsy Society regarding pregnancy management. Seizures themselves create high risk for injury or death to the mother and fetus; medication is unavoidably necessary. There is no risk-free option for women with epilepsy who get pregnant.

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    EG: Thank you for those of your comments that are useful informational. I agree that there are risks to taking and to not taking a drug. You are correct that there is not a “risk-free” option. The best a patient can do is weigh the risks in consulation with their doctor and then make the best decision under the circumstances of their medical condition. I think that it is important that the accurate adverse event date be provided to the treating physician so that they can provide advice to their patients and a risk-benefit analysis can be made. The problem that I see with the FDA reporting as mentioned in the blog entry is that the FDA data is often incomplete, not accurately grouped, and/or not up to date making it more difficult for a doctor and their patient to be informed. I also agree that among the anti-epileptic drugs, there is much less risk with Keppra or Lamictal than with, for example Topamax.

  3. Paul Nim says:
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    Michael Monheit:
    Thank you very much for such an eye opening article, that would never have been printed by the pharmaceutical companies! Most people are not fully aware of the possible side effects of certain, and most recently marketed, AED’s on pregnancy, regardless of how they compare to others. Most women are unaware of the risk-free options that do not exist. The FDA is in no immediate rush to give unsolicited opinions on recently marketed AED’s; they’re unaware of the long-term side effects. There actually is an option to an epileptic becoming pregnant and possibly passing on birth defects…adoption!
    The article wasn’t due to “shocking ignorance”; it was a result of “educated boldness”. Keep up the good work.

  4. EG says:
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    My comment about ignorance referred to the lack of acknowledgement that there are on-going surveillance projects (pregnancy registries) that are supplying with us more reliable information that is not controlled by the drug companies. In addition the manufacturers do provide pregnancy info (e.g. http://www.lamictal.com/bipolar-I/patients/form_of_lamictal/faqs-about-lamictal-odt.html). It is often not a matter of hiding information; until there are at least several hundred pregnancies on a drug, it is not possible to state what the risk of birth defects is. Adoption is always an option, but many women wish to have their own children (the entire assisted reproduction industry is devoted to this). In the past the other option was legally enforced involuntary sterilization of women with epilepsy; I don’t think anyone wants to go back to that. It is not a matter of these being “defective” products causing birth defects. A woman who needs these medications and is properly informed by her physician about possible risks is making an informed choice. I am not sure why this is an issue for litigation; no lawsuit can make the drugs any safer or prevent any future birth defects. Nor am I sure why the above article is “educated boldness” — this information is freely available in the drug package inserts, the PDR, and the internet.

  5. Tink says:
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    As a mom with epilepsy, I knew there was a risk. I had to go based upon information from a good neurologist and an OB with knowledge on the effects of seizures and AEDs on epilepsy. I don’t trust the FDA on must of anything. I personally believe they are in the back pocket of drug companies. There are many women with epilepsy who have had children. A good neuro would try to minimize the amount of meds she takes as much as possible as soon as she is aware she is pregnant. Women taking AEDs should also take 4 mg of folic acid long before trying to get to conceive. Don’t exclude us from having the joys of bearing children. We want it just as much as others, we just have another hurdle that some women don’t.

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    Paul, EG, Tink, Thank you for your comments. They are insightful and helpful in raising awareness about the challenges faced by women of childbearing age who have seizures. As always, my hope is that accurate information is shared with doctors and that they can then offer informed risk-benefit advice to their patients about the these drugs. What upsets me is when information is not made available and then uninformed (and sometimes wrong) decisions are made.