The proposed therapeutic range for seizure control is 30-60 µg/mL. Pharmacokinetics vary widely, particularly with co-medications, age and/or compromised renal function. Felbamate use is associated with an increased incidence of liver failure and aplastic anemia.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.