Epilepsy Talk

BEWARE! AED Safety Risks Withheld | August 18, 2013

Medical News Today — Article Date: Aug 17, 2013

A study by Johns Hopkins researchers shows that a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

The findings suggest that the U.S. Food and Drug Administration needs a better way to communicate information to specialists about newly discovered safety risks, the researchers say, since the warnings are in many cases not getting through to doctors making important prescribing decisions.

And, the researchers add, while their new study, reported online in the journal Epilepsy and Behavior, was focused on neurologists and anti-epilepsy drugs, they believe their findings are applicable to a wide spectrum of medical specialists and medications.

“There is poor communication from the FDA to specialists, and there’s some risk to patients because of this,” says study leader Gregory L. Krauss, M.D., a professor of neurology at the Johns Hopkins University School of Medicine.

“Unless it’s a major change requiring the FDA to issue a black box warning on a product, important information appears to be slipping through the cracks.

We need a more systematic and comprehensive method so that doctors receive updated safety warnings in a format that guarantees they will see and digest what they need to protect patients.” 

Krauss and his colleagues surveyed 505 neurologists from across the nation in different types of medical practices between March and July of 2012.

They asked about several new safety risks for antiseizure drugs recently identified by the FDA: increased suicidal thoughts or behavior with newer agents; high risks for birth defects and cognitive impairment in offspring of mothers taking divalproex (sold by the brand name Depakote); and risks for serious hypersensitivity reactions in some patients of Asian descent starting treatment with carbamazepine (Tegretol).

One in five of the neurologists surveyed said they knew of none of the risks.

Those neurologists who treat two hundred epilepsy patients a year or more were most likely to know all of the risks.

Krauss says he was most struck by the lack of understanding of the risk to certain Asian patients who take carbamazepine to control their seizures.

The FDA in 2007 recommended that before initiating the drug in patients of Asian heritage, neurologists should screen to see if those patients have a specific haplotype, a specific section of DNA found in a few percent of Asian people, before prescribing the drug.

The researchers found that 70 percent of the neurologists who responded knew of the recommendation.

While 147 neurologists (29.1 percent) reported initiating carbamazepine treatment in Asian patients, only 33 of them (22.5 percent) said they performed haplotype screening.

Eighteen neurologists reported that their Asian patients developed carbamazepine-related hypersensitivity reactions — severe skin rashes that can lead to scarring, blisters in the mouth and shredding of the skin – during this time period.

“If their doctors were more educated about the risks,” Krauss says, “these patients may have avoided these severe hypersensitivity reactions.”

Krauss says doctors may not do the screening because it is difficult to find laboratories able to perform the haplotyping, and he notes that it may make more sense to prescribe an alternate drug to Asian patients.

The researchers found that 80 percent of respondents knew that the FDA had newly warned that the risk of suicide with newer drugs is 4.3 per 1,000, double what had previously been believed.

Seventy percent said they counseled patients about the risk.

As for pregnancy risks related to divalproex, fewer than half of the respondents knew that a warning had been issued noting high risks of birth defects and of developmental risks in offspring (an 8 to 9 point drop in IQ).

While 93 percent of respondents reported counseling women planning pregnancies about the birth defect risks of divalproex, Krauss says safer drugs should be used if possible during pregnancy.

Krauss says part of the problem is the absence of a single place for neurologists to find updated risk information.

Neurologists get safety information from scattered sources; only a few get emails from the FDA, while others get the information from neurology societies, from continuing medical education courses or from newly published journal articles.

“The FDA needs to do better getting the warnings to prescribing doctors,” he says.

“There has to be a direct way to communicate risks without overwhelming physicians with messages.”



Another article of interest: Many Neurologists Unaware of Safety Risks Related to Anti-Epilepsy Drugs http://www.sciencedaily.com/releases/2013/08/130814192251.htm?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+sciencedaily%2Fhealth_medicine%2Fepilepsy+%28ScienceDaily%3A+Health+%26+Medicine+News+–+Epilepsy+Research%29

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  1. The sad part is that it’s not surprising! Unfortunately integrity in the pharmaceutical industry is a thing of the past.


    Comment by Charlie — August 18, 2013 @ 7:52 PM

    • Oh Phylis, I had Keppra rage. At the time, we attibuted to my “sranger than fiction” Personality. So, when my husband heard me screming with rage, I continued taking it ’til my next doctor’s appoinment..Then we told him that I was feeling mad. MAD?! I was given the wrong meds so many times I really thought I would kill myself and so I made provisions for that. Never took my calming Xanax, stored Soma, did not swallow my codeine tabs—indeed, I did not get hooked on my codeine pills. But after 11 or so falling down episodes,I had enough stuff to kill me three times.But here I am. No seizures, no mood swings and I am taking just one pill a day for my seizure activity, am happily taking Zonisamide/Zonigran. Neve felt better in my life. The drug conbined with Garcinia Cambogia, has made me whole again. I am HAPPY! Just as speedy as I was in law school. I am once again my old me! Lost weight, look beautiful (and self love was always my flaw.


      Comment by Michele McKenzie — February 17, 2014 @ 5:13 PM

      • Oh Michele, you are always beautiful — inside and out. (Teeth and all.)

        Why didn’t you take your “calming meds”? Because you forgot or were too enraged? Or were you just saving them for suicide?

        I’ve been there. It’s pretty messy. Especially when you fail. (Which I obviously did.)

        But it did change my life — and priorities — for the better.

        I gave up 24 years of advertising writing and started Epilepsy Talk. (With the very generous support of my husband.)

        By the way, I fall down about twice a week. Last week I destroyed a velour outfit (pretty sturdy fabric) and cashmere pants. This is getting pretty expensive.

        Glad to hear you’re back to your “old” self. Go get them beautiful! 🙂


        Comment by Phylis Feiner Johnson — February 17, 2014 @ 5:54 PM

  2. It’s interesting how “politically correct” the article is. Not once do they point their fingers at the pharmaceutical companies. And their criticism of the FDA is pretty gentle also.

    Unlike the second link:

    Epilepsy Studies: True or False?



    Comment by Phylis Feiner Johnson — August 19, 2013 @ 9:27 AM

  3. Reblogged this on Vintage Lavender and commented:
    Check Your Meds !!


    Comment by VintageLavender — August 19, 2013 @ 2:20 PM

  4. I think the article may randomly select neurologists. I think most of us see epileptologists. And the do know drug reactions. But a general neurologist may only see a few people with epilepsy a year and can’t know the reactions to all the meds he may be prescribing… That’s why we need to ask the neurologist how many patients he or she treats with epilepsy? We are entitled to know. And push that this is is an active number, not over their carrier. If you live in a rural area you may be out of luck and your pharmacist is your best resource. But I found that I’m my best resource with my lap top… Good luck. Sally


    Comment by Sally komar — August 20, 2013 @ 6:25 AM

  5. All epileptologists are all neurologists but not vice versa.

    So they’re coming at this with a bettter understanding.

    My best friend is my pharmacist (as you may have read in other articles).

    Sally’s best friend is her laptop for a reason: No one can research as thoroughly as her.

    All that being said: When your doctor prescribes something, you should think it’s for a good reason.

    Not HOPE that it’s for a good reason!


    Comment by Phylis Feiner Johnson — August 20, 2013 @ 8:18 AM

  6. Again, yes this to me isn’t surprising at all. I’m glad more literature is coming out providing the reality behind ‘some’ AED’s. I reduced my medications (Keppra and Zonegran) and they i) didn’t work for me and ii) introduced some very negative side effects into my life such as cognitive impairment, slowed speech, indifferent sleep patterns, I could go on. There are other alternative ‘options’ that individuals could consider be going down the pharmaceutical road. Whatever happened to good advice from doctors about appropriate eating options, good sleeping patterns, good mineral, vitamin intakes? I would have been very grateful in receiving this basic information prior to receiving regular prescriptions. In the UK, we receive free prescriptions if you have epilepsy…I’d put the questions out there “is this a good thing or bad thing?” especially if we’re led to believe these AEDs have minimal side effects, whereas they may in fact be causing more harm than good.

    Recently, upon my last visit to my neurologist I asked him “Did any of the past AED’s I’d taken (note, I’ve taken up to nine different types) pose any risk to me having children?”.

    His answer was, “remind me of which one’s you’ve taken?” As a patient you’d much prefer the answer “no”.

    The story continues.



    Comment by neuropickings — August 20, 2013 @ 11:51 AM

  7. “Remind me of which ones you’ve taken” would have had me speeding out the door. (Can you do that in the UK?)

    On one hand, I’m VERY lucky. I have a FABULOUS neuro who spends 45 minutes with me, calls if there’s something he’s uneasy about and was nice enough to SAVE my life. 😉

    And THIS time, I’ve found my “magic mix.”

    But, (there’s always a “but” somewhere), I haven’t always been lucky. At all.

    I had a neuro so stupid, he couldn’t remember my name.

    That was the same guy that put me on a toxic level of Dilantin.

    And tell me, was it the drug companies, the FDA or the med journals which made him “forget” to tell me about galloping gum rot, falling out hair and so forth.

    So MY happiness is having reliable meds that WORK, a kind and caring neuro, a good periodontist who saved my teeth. And you know, short hair is much easier to manage.

    But that doesn’t mean any of us should “go with the flow”.

    And bad “manners”, we won’t start about that! (I loved your blog…)


    Comment by Phylis Feiner Johnson — August 20, 2013 @ 1:08 PM

  8. I’m glad I read this cause over 20 years ago I was on that med and I was hyper and got mad at people and would do other things too. I ended up in mental heath places for about 4 years too.Now these days I’m completely different.


    Comment by Corina — August 21, 2013 @ 10:45 AM

  9. Just more reason to be skeptical of my docs and the so-called experts. I’m so sick of going to people who act like they know everything, but feeling like I can’t trust what they tell me. And, then, they look at me like I’m crazy for questioning them..


    Comment by Doug — August 21, 2013 @ 12:10 PM

  10. See an epileptologist. Neurologist don’t know as much. I find myself knowing more than some neurologist.


    Comment by Tony Murray — August 28, 2013 @ 2:52 PM

  11. Neuros stop training after their neurology residency.

    Epileptoligists have to study further for their certification.

    So, it would make sense that since they’re better educated in their specialty, they’ll be better equipped (educationally) to deal with your condition.

    That being said, any doc is only as good as his dedication to keep current. If your doc (or ANY doc) isn’t up to date on research and development of new meds and new procedures, you’re being deprived of further possibilities and treatments.

    (Just ask Charlie who had a botched brain surgery before he came to NYU!)


    Comment by phylis — August 29, 2013 @ 11:19 AM

  12. Has anyone heard that phenobarbital ( 160mg daily for 30+ yrs) can cause osteopenia/osteoporosis? My meds have worked to control seizures but now she says I should switch to Keppra due to my now having bone density issues. Kinda freekin out here!!


    Comment by Jeannie — August 29, 2013 @ 5:05 PM

    • Statistics: Percentage of PHENOBARBITAL patients where OSTEOPENIA is a reported side effect: 0.4739336492891%

      Given the options, I would stay where you are.

      Doctors are very eager to prescrive Keppra today as the first line of AEDs.

      However, if you read the following article (and the comments) you might not think it’s such a great idea…

      Keppra – What People Are Saying…


      It’s always a good idea to do your own research and be pro-active as you are being Jeannie!


      Comment by Phylis Feiner Johnson — August 29, 2013 @ 8:29 PM

      • She’s right Jeannie. The transition after taking pheno for so many years may be bumpy as well. And keppra can also cause bone loss, just so you know.

        Phylis, that statistical percentage was cool. Where did you get it? Do they have one for Dilantin users too?


        Comment by Doug — September 1, 2013 @ 2:16 PM

    • I’ve been on Pheno’s 26 yrs & have the same problem. Funny thing is that the bone density scan Fluctuates. Good, bad, good, bad. 😦 My Primary Dr & I just had another ‘discussion’ where he claimed Pheno’s Don’t cause bone loss. I guess we are ‘rare’ & now can add 2 more to those Stats Phylis posted. 😉 Anyway, I gave him Legit Sites to read a yr ago. 😦 He Still says Don’t believe what you read. (In other words, he Didn’t read the Info. ) He gave me Fosamax after second scan. I took 1 mths worth. Then I noted the ad on TV warning about Fosamax. I Quit Immediately. I told him Why. Well, don’t believe Ads. The side effects are ‘rare’. 😦 (So are the Pheno Side effects. HMMPH!) I Know I have the Right to refuse any med. Same as You. Ask your DR if there is another anti-seizure med choice for you. Take your Calcium Supplements. Calcium Citrate, once a day, Calcium +D3, once a day, plus multi-vitamin. BTW: Only take 500-600IU at a time. Our systems don’t absorb more than that at the time we take the dose. Be Sure to take these Supplements 30 minutes to an hr B4 you take your Anti-seizure med. I wish you Luck if you do transition off Pheno’s to another med. Hugs!


      Comment by candi — September 13, 2013 @ 11:00 AM

      • Fosamax is POISON. Many dentists won’t see patients who take Fosamax because it causes necrosis of the jaw.

        (Aren’t we supposed to be trying to prevent osteoporosis when taking bone building supplements?)

        So why recommend a drug that could lead to necrosis?

        There’s a very good article in Mayo Clinic about it.

        “Fosamax and other bisphosphonates: Unusual risks?

        How serious are the risks of bisphosphonates, such as alendronate (Fosamax) and risedronate (Actonel), when taken for osteoporosis? Can they actually cause additional bone problems?”


        Candi has been taken Pheno for 26 years and she’s still standing.

        As for the doc, it’s clear he hasn’t done his homework and/or doesn’t care.

        He could be in the “pharmacist’s pocket”, but whatever, he’s doing women a grave disservice.

        I don’t know whether he’s ignorant, lazy or just doesn’t care.


        Comment by Phylis Feiner Johnson — September 13, 2013 @ 12:33 PM

  13. On Aug, 23, 2013: 10,544 people reported to have side effects when taking Phenytoin. Among them, 1 people (0.01%) had Ovarian Cysts.


    On Aug, 26, 2013: 17,926 people reported to have side effects when taking Keppra. Among them, 32 people (0.18%) had Ovarian Cysts.


    After an hour of research, I could find nothing that indicated that Dilantin causes ovarian cysts.

    And this is information you probably already know…

    According to a study published in the esteemed medical journal Neurology, younger women who are taking the popular anti-seizure medication Dilantin are eight times more likely to develop significant bone loss, including osteoporosis, compared to other pre-menopausal women who do not take Dilantin, or the generic phenytoin.

    According to one doctor involved in the study, the effects of Dilantin on bone health were surprising.

    He also noted that the rate at which Dilantin causes bone loss is significant and that more patients and doctors should be aware of this serious possible risk.

    The study found that women taking Dilantin experienced a loss of 2.6 percent of their bone mineral density in one year, with the greatest loss occurring to the femoral neck of the hip bone.



    Comment by Phylis Feiner Johnson — September 1, 2013 @ 3:37 PM

  14. That lawsuit site could make the same claims for just about any AED. They could list all the side effects and file a lawsuit for Keppra as well. I don’t know what drug to turn to really.


    Comment by Doug — September 2, 2013 @ 4:48 PM

  15. A lawsuit again a pharmaceutical company is a losing proposition. They’re pockets are MUCH deeper than yours.


    Comment by Phylis Feiner Johnson — September 2, 2013 @ 7:09 PM

  16. Greetings! I’ve been reading your blog for a long time now and
    finally got the courage to go ahead and give you a shout
    out from Kingwood Tx! Just wanted to tell you keep up the excellent


    Comment by ruptured ovarian cyst — January 16, 2014 @ 1:23 AM

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    About the author

    Phylis Feiner Johnson

    Phylis Feiner Johnson

    I've been a professional copywriter for over 35 years. I also had epilepsy for decades. My mission is advocacy; to increase education, awareness and funding for epilepsy research. Together, we can make a huge difference. If not changing the world, at least helping each other, with wisdom, compassion and sharing.

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