[News] Keppra warning

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Today my wife found a change in the possible side effects of Keppra. Just spreading the word incase you have been prescribed it and are unaware of the possible side effects.

3 w's .

accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf

Just so you know.
 
The link below should be accessible:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021035s093,021505s033lbl.pdf
The changes to the list of side effects appear to be minor additions within the sections noted below. I've pulled out the new/revised text within those sections.
5.1 Behavioral Abnormalities and Psychotic Symptoms
KEPPRA may cause behavioral abnormalities and psychotic symptoms. Patients treated with KEPPRA should be monitored for psychiatric signs and symptoms.
5.3 Somnolence and Fatigue
KEPPRA may cause somnolence and fatigue. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on KEPPRA to gauge whether it adversely affects their ability to drive or operate machinery.

Somnolence and asthenia occurred most frequently within the first 4 weeks of treatment. In general, the incidences of somnolence and fatigue in the pediatric partial onset seizure studies, and in pediatric and adult myoclonic and primary generalized tonic-clonic seizure studies were comparable to those of the adult partial onset seizure studies.
5.7 Hematologic Abnormalities
KEPPRA can cause hematologic abnormalities. Hematologic abnormalities occurred in clinical trials and included decreases in red blood cell (RBC) counts, hemoglobin, and hematocrit, and increases in eosinophil counts. Decreased white blood cell (WBC) and neutrophil counts also occurred in clinical trials. Cases of agranulocytosis have been reported in the postmarketing setting.
5.8 Increase in Blood Pressure
Monitor patients 1 month to <4 years of age for increases in diastolic blood pressure.
 
If this is all ^ it says, it's nothing new and I've been on Keppra for 13 years.
 
I had a bad time when I was briefly on Keppra and I am glad for whatever warnings they offer. I thought I was going around the bend forever -- and I don't thank anyone for the experience. Bidwell
 
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