Patients taking antiepileptic drugs had nearly twice the risk of suicidal behavior or thoughts than those taking a placebo, according to FDA analysis. Epilepsy drugs are commonly prescribed for migraine or headache prevention.
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
- Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
- Felbamate (marketed as Felbatol)
- Gabapentin (marketed as Neurontin)
- Lamotrigine (marketed as Lamictal)
- Levetiracetam (marketed as Keppra)
- Oxcarbazepine (marketed as Trileptal)
- Pregabalin (marketed as Lyrica)
- Tiagabine (marketed as Gabitril)
- Topiramate (marketed as Topamax)
- Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
- Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
I don’t know anything else right now, but will update you when I learn more.
Alexander Mauskop, director of the New York Headache Center, regularly posts his thoughts on current headache news on the aptly named Headache NewsBlog. He dispels myths and examines closely media coverage of headache news. Here’s a taste of Mauskop’s blog, but look over Headache NewsBlog to get the full flavor.
Sleep is a precious resource that many people, particularly those with chronic illness or pain, don’t get enough of. If you’re a woman who has triumphed over your sleep problems, Laurie from A Chronic Dose wants to hear your story for an article she’s writing.
The National Sleep Foundation is an amazing resource for those still struggling with sleep. For information on sleep and headache disorders see Sleep, Sweet Elusive Sleep.
If good sleep still eludes your (or if you’re a man!), please share your experiences in the comments for this post.
I need your input. I’m forever being asked what I know about particular headache specialists or clinics. I know the ones I’ve seen and that’s about it. You’re the expert on what you’ve experienced. Please share your opinion by commenting on the doctor who treats your headaches.
Fine print: You may identify the doctor or clinic by name, but be nice even if you didn’t think much of the doctor. You can point out what you disliked without trashing the person. Please keep in mind that people have differing opinions about particular doctors. I will delete inappropriate comments.
Health insurers have provided doctors with financial incentives to prescribe generic medications, according to an article in yesterday’s Wall Street Journal:
Health plans are drawing scrutiny for offering financial incentives to entice doctors to prescribe cheaper generic medicines, including paying doctors $100 each time they switch a patient from a brand-name drug.
Pharmaceutical companies have long gone to great lengths to try to get doctors to prescribe their brand-name pills. They spend billions of dollars, plying physicians with samples, educational lunches and speaker fees. But as the patents for a growing number of blockbuster medicines expire, some health insurers are trying to trump those perks with bonuses or higher reimbursements for writing more generic prescriptions.
The idea, health plans say, is to save everyone — patients, employers and insurers — money. And many doctors argue that it’s only right to reimburse them for spending time evaluating whether a cheaper generic alternative is better or as good for a patient.
Thanks to Dr. Christina Peterson of Migraine Survival for the heads up.