January 15, 2009
At this point I don't know yet what caused John Travolta's son Jett to die, as the autopsy results won't be back for a few days. But suspicions are running high that he had a seizure that led him to hit his head in the bathtub. It is also currently a matter of unconfirmed rumor that he may have not been taking anti-seizure medications in recent months, as his parents, who are scientologists, often reject standard medical treatments.
The problem of inadequate seizure treatment is widespread among adolescents, not just celebrities. Studies show that 66% percent of adolescents can have their seizures stopped with medication.
Nevertheless, until recently, the FDA has been thinking about putting warning labels on anti-seizure medications commonly used to treat epilepsy, because of recent findings that these drugs may increase a patient's risk of suicide. Of course, patients with epilepsy already have a mortality rate of 2-3 times the general population, and this rate increases dramatically for patients who don't take medication to treat the condition. So warning people away from these essential medicines would seem to be somewhat irresponsible.
Yet in January, the FDA was seriously considering targeting 11 anti-seizure medications used to treat epilepsy. These drugs were carbamazepine (Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), and zonisamide (Zonegran). These drugs are not only extremely useful for seizures, several of them are also used effectively for pain, migraine, or to stabilize a patient's mood.
Then, in July, the FDA announced its intention of adding a black box warning about suicide risk to the drugs' label. But the same month, an FDA panel advised against these warnings for fear they would lead to a decreased use of these essential medications. Sage advice, in my opinion.
Luckily, the FDA decided to listen to its own panel, and NOT issue the black box warning. Readers of this column know that I spend half of my time here writing about how black box warnings (the most serious kind) too often scare people away from life-saving drugs.
So the FDA reversed its position in time, though they did continue to advise doctors to look out for changes in “mood, behavior and actions” of patients on the drugs mentioned above. This advice would appear to be prudent, and I have no problem with it. Unfortunately for Jett Travolta, no doctor appeared able to reach the family with a prudent anti-seizure treatment in time.
And regarding the FDA, I do have a problem with is a philosophy of caution and concern that comes directly from fear, is fueled by media hype, and too often lacks a full awareness and perspective regarding the great health advances of modern medicines.
Marc Siegel, MD, is an internist and professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear