Back in January, the U.S. Food and Drug Administration (FDA) warned doctors that drugs used to treat epilepsy (also called antiepileptic drugs or AEDs) may raise the risk of suicidal thoughts or actions (according to a USA Today story). It came to this conclusion after examining 199 studies that looked at 11 different anti-seizure medications, such as Neurontin, Tegretol and Depakote.
Earlier this month, a panel at the American Epilepsy Society 62 Annual Meeting (as reported by Medscape) disputed the FDA’s findings and suggested that the methodology that the FDA used was severely flawed, resulting in a recommendation that was also flawed:
After crunching the numbers, Drs. Hesdorffer and Berg told meeting attendees that the study findings are inconsistent across the 11 drugs. The results are also inconsistent by indication and vary greatly between epilepsy and other psychiatric disorders, they said. In addition, the findings are inconsistent by region.
“The increased risk of suicide was not seen in all drugs, and there is no explanation as to why,” Dr. Berg said. “This is a bureaucratic, not scientific, decision.”
“There is the potential for a lot of damage here,” said presenter Rochelle Caplan, MD, a pediatric and adolescent psychiatrist from the University of California, Los Angeles. “Parents are not going to want their children on these medications if they are concerned about an increased risk of suicide. It is unfortunate that the FDA released this information before there are data to substantiate it.”
Sadly, the FDA didn’t notice or didn’t care that their findings were disputed.
Today, the FDA ordered drug makers to add a warning that the medicines carry a risk of suicidal thoughts or actions, according to a Reuters news report. Such a warning is likely to have a chilling effect on the prescription of these drugs to people who need them.
The increase represented about one additional case of suicidal thinking or behavior for every 530 patients treated with one of the medicines, the FDA said.
Remember, that’s just “suicidal thinking or behavior,” not actual suicide or anything of the like. And 1 in 530 chance is not something most people would have to worry about. To put it into perspective, according to the National Safety Council, your lifetime chances of dying as a car occupant are 1 in 261, or dying from a fall, 1 in 192.
A 1 in 530 chance is still significant, but I wonder at the public health risk of making this so well publicized versus people forgoing such medication because they believe they are at serious risk in taking it.
The FDA also seemed to ignore research (see second Medscape reference) that shows that people with co-existing (co-morbid) psychiatric conditions and those newly diagnosed with epilepsy are at 3 times greater risk for suicide than others. The 199 studies the FDA looked at generally didn’t measure for these findings (since they were just discovered in 2007), nor did the vast majority of them have any type of psychiatric measurement.
The FDA also said:
The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions,’ the agency said.
Which is in direct contradiction to the experts quoted in the Medscape article, who said that the findings were inconsistent across medications.
Whom should you believe? Well, I think that if you’re taking such a medication, you should be more aware of your moods and especially sensitive to depressed or suicidal thoughts. And if you’re a new patient (or have a child newly diagnosed with epilepsy), this is a piece of information that is important to note. But it shouldn’t stop you for a moment in filling a prescription for an epilepsy drug for yourself or your child, because the evidence simply isn’t as strong as the FDA purports.
Read the USA Today article: FDA issues suicide warning for epilepsy drugs
Read the Medscape article: AES 2008: Panel Disputes FDA Finding on Antiepileptics and Risk for Suicide
Read the Reuters article: U.S. orders suicidal action warning on epilepsy drugs
Read the Medscape article: Epilepsy Conferred 3-Fold Increased Risk for Suicide in Large Study
6 comments
I agree that those who use the drugs for epilepsy should just be more aware of their moods and any feelings of depression. It doesn’t surprise me that these drugs could be associated with increased risk of suicide, because the same drugs are also used to treat bipolar disorder as “mood stabilizers.” As far as I understand, the drugs are used in bipolar disorder to prevent and control mania, but that they don’t help much or at all with depression. The drugs don’t know whether they are intended to help any given patient with bipoloar disorder or epilepsy. All of the effects of the drugs would affect everyone who takes the drug.
I hope that people who take these drugs for epilepsy don’t let this announcement keep them from getting treatment. However, given the increases in diagnosis of bipolar disorder, especially in children and adolescents, I hope that we do see a decrease in prescription of these medications because I think that they are being over-used.
Doctors and professionals who once diagnosed behavior challenges as ADHD and prescribed stimulants are now diagnosing many of the same behavior challenges as bipolar disorder and prescribing mood stabilizers. I hope that they will back off on the prescriptions and focus on behavior management, parent training, and accepting that normal children respond to developmental challenges and environmental conditions in ways that adults around them don’t always enjoy, but that doesn’t mean that all of those children are mentally ill and need drugs.
The article doesn’t include ALL the drugs. There are many other drugs of this category that are not included. Lamictal? Trileptal? Those are common and I take them myself. How do I go about finding all the information?
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The drugs to get the warning are:
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of the drugs might also be available as a generic.
The American Epilepsy Society said Tuesday that FDA’s analysis was “flawed” and was concerned the warnings would cause patients to stop treatment.
“The risk of suicide possibly associated with [the epilepsy drugs] is extremely small compared to the potential danger of leaving patients untreated,” the group said in a statement.
It’s not only the patient that needs to be aware of the symptoms. The doctors also need to listen to their patients and understand that they know more about their bodies than Dr.s do. After taking carbamazepine for almost 10 years with symptoms slowly developing- generalized rashes when my skin came into contact with anything, bruising, continuous low grade fever, anemia, sore throat, ‘sore’ organs (kidneys, liver, tonsils), blood in the urine, anxiety attacks, my skin getting severe rashes that looked and felt like chemical burns, etc., I started to have suicidal thoughts. It was not a thought process but literally, images of me killing myself just popping into my mind! It scared the heck out of me (!!)so I decided to stop taking carbamazepine. And all along my doctors would ignore me when I reported my symptoms because they did not happen all at once.
It’s disappointing that SOME Dr.s care more about getting in as many patients as possible in a day without taking the time to really find out what is wrong with the patient.
I think an increase of 1 additional suicide for 530 is significant enough to warrant a warning.
It’s just a label or warning – the FDA is not banning the drug. Should we not inform the public of other potential adverse, or more rare, side effects of drugs just in case it might discourage usage?
Hopefully more people who take these medications, along with their family members, will be more alert in identifying suicidal behavior.
For those against such warnings, if the 1 in 530 happened to be your son, daughter, mother, or spouse, and you had no previous knowledge of the potential risk, would you still have this complaint?
For many drugs I’ve been prescribed in my lifetime, I was never warned of any of the potential adverse side affects by the writers of the prescriptions.
It’s just a warning. The odds of being in a plane crash are much greater than 1 in 530, yet there are safety demonstrations conducted before every airplane takes off in the U.S. Yes, even airplanes that hold only 20 people.