Suicidal Risk with Anti-seizure drugs

Suicidal Risk with  Anti-seizure drugs

FDA "sent an alert to doctors warning that epilepsy drugs may increase the risk of suicidal thoughts or behavior." The agency's "investigation involved 11 well-known anti-seizure medications," but the FDA "says the risk applies to every epilepsy drug, and it plans to work with manufacturers to add new warning labels."

        The Wall Street Journal (2/1, B6, Dooren) reports that the FDA stated on its website that "it looked at nearly 200 clinical studies involving the 11 drugs, and found a doubling of the risk of suicidal thinking or behavior." According to the agency, "patients receiving any of the 11 drugs had approximately twice the risk of suicidal behavior or ideation, or 0.43 percent, compared to 0.22 percent of patients receiving placebo in studies involving about 44,000 patients." Furthermore, the increase in risk "was observed as early as one week after starting an anti-epileptic drug, and continued through 24 weeks."

     The "medications are primarily used to help epileptics control seizures," as well as "to calm the surges in energy and mood that, along with bouts of depression, characterize bipolar disorder." Several of the drugs (for example, Topamax [topiramate] and Neurontin [gabapentin]) "are sometimes prescribed for chronic pain and headaches, as well."

      The studies reviewed by the FDA "tracked almost 28,000 people who took the medications." After comparing the medication group against "16,000 others who took placebos," the agency found that among people taking the drugs, four "committed suicide," whereas no one in the placebo groups did.

        The FDA "said it expected the risk was shared by all anti-epileptic drugs," Reuters (2/1) adds. The FDA further stated that "changes to the drugs' prescribing instructions would be applied broadly throughout the class."

      

        Anticonvulsant "drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder, that themselves carry a risk of suicide." While the agency "found drug-treated patients were at increased risk no matter their diagnosis," the suicide risk "was highest for epilepsy sufferers."

        The medications cited in the FDA warning include

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1. carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR),
   
2. felbamate (marketed as Felbatol),
   
3. gabapentin (marketed as Neurontin),
   
4. lamotrigine (marketed as Lamictal),
   
5. levetiracetam (marketed as Keppra),
   
6. oxcarbazepine (marketed as Trileptal),
   
7. pregabalin (marketed as Lyrica),
   
8. tiagabine (marketed as Gabitril),
   
9. topiramate (marketed as Topamax),
   
10. valproate (marketed as Depakote, Depakote ER, Depakene, Depacon), and
    
11. zonisamide (marketed as Zonegran)."
    

Many of these drugs also have generic versions.

       

FDA "said it has not established a causal relationship between the antiepileptics" and the increased risk of suicide, nor is the agency "advising healthcare professionals to discontinue prescribing these products."

        "Healthcare professionals" are being urged to "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."