Beginning in 2008, the FDA began notifying clinicians of the potential of antiepileptic drugs to increase suicide risk and earlier in 2009 issued a public health advisory notifying the public of this increased risk. Also, the FDA is mandating that manufacturers of antiepileptic drugs change the labeling of their meds, adding this risk to the Warnings section of the drug insert.
The FDA review included the pooled results of 199 clinical trials of eleven antiepileptic drugs that are used to treat epilepsy, psychiatric disorders and other conditions. In these trials, patients who took one of the antiepileptic drugs either as mono- and adjunctive therapy had almost twice the risk of having suicidal thoughts or behaviors as compared to patients who did not take one of the drugs (0.43% for medication versus 0.24% for placebo).
This increase in the risk of suicidal thoughts or behavior represents the occurrence of approximately one additional case of suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug.
The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs with varying mechanisms of action and across a range of indications – although the relative risk was larger for patients taking the drug for an epilepsy indication than was the relative risk for patients taking the drug for a psychiatric indication (RR of 3.5 vs. 1.5). These observations suggests that the risk applies to all antiepileptic drugs used for the different indications.
The FDA Warns: “All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.”
The Eleven Antiepileptic Drugs
* Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
* Divalproex sodium (Depakote, Depakote ER)
* Felbamate (Felbatol)
* Gabapentin (Neurontin)
* Lamotrigine (Lamictal)
* Levetiracetam (Keppra)
* Oxcarbazepine (Trileptal)
* Pregabalin (Lyrica)
* Tiagabine (Gabitril)
* Topiramate (Topamax)
* Zonisamide (Zonegran)
Today’s Tip
On your cell phone enter a new contact called “ICE.” This stands for “In Case of Emergency.” If you’re ever incapacitated first responders are trained to look through your cell phone. You can have more than one ”ICE” contact, one for each family member. For instance, you can have “ICE 1 Spouse,” ICE 2 Brother,” and “ICE 3 Mother.” And, of course, you add the phone and any other information you wish for each contact.
If you have a medical disorder that may incapacitate you and there are specific procedures that should be followed to save your life or to prevent wrong actions from being taken, you can write a detailed note attached to your ICE contact. You can even attach audio or video recordings explaining what should be done. Most cell phones have such capabilities.
And, of course, this tip may be very useful for your patients too. Consider how a patient with epilepsy could make use of this. If you have more insights into the use of ICE of similar approaches, please leave a comment. Thanks. Jack
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