FDA Warns of Potentially Lethal Reaction to Seizure Meds
Megan Brooks reports:
“The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the US Food and Drug Administration (FDA) warns in an alert issued today.
Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.
Three cases occurred in the US, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in two cases, the patients died.
The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4). The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4)…. DRESS symptoms resolved when levetiracetam was discontinued.”
Low Doses of Levetiracetam Acutely Improve Mild Cognitive Impairment
Levetiracetam, an anticonvulsant often used to prevent seizures in epilepsy, may improve memory by decreasing hippocampal hyperactivity. Hippocampal hyperactivity in amnestic mild cognitive impairment (aMCI) was once thought to be beneficial, but results from a recent study suggest that increased activity in this structure may contribute to memory impairment. Levetiracetam was effective for memory when given in much lower doses than those used to treat epilepsy.
In a study by Michela Gallagher and colleagues presented at the Alzheimer’s Association International Conference in 2011, a placebo-controlled, randomized crossover design was used to collect data from 17 aMCI patients and a similar number of healthy controls. Both groups went through two distinct treatment periods. People in the control group received placebos in both periods, while patients with aMCI received placebo during one period and low-dose levetiracetam (125mg twice daily) in the other period. After 2 weeks of taking the drug, hippocampal hyperactivity among aMCI patients decreased into the normal range, and memory was improved to the level of the healthy controls.
Editor’s Note: The findings from this small study are preliminary and need to be replicated in larger and longer studies before they are applied clinically. As we noted Friday, very low doses of lithium (150mg/day) prevented the progression of mild cognitive impairment compared to placebo in a one-year study. Whether these effects of levetiracetam or lithium are reliable, are of large effect, and occur by similar or different mechanisms remains to be determined.