FDA Issues Alert for Epilepsy Drugs, Despite Controversy
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
Grohol, J. (2018). FDA Issues Alert for Epilepsy Drugs, Despite Controversy. Psych Central. Retrieved on December 5, 2020, from https://psychcentral.com/blog/fda-issues-alert-for-epilepsy-drugs-despite-controversy/