Patient pharmacokinetics may be variable due to age, co-medications, and/or compromised renal function. Adverse effects may include nausea, vomiting, dizziness, blurred vision and ataxia. Felbamate use may increase the 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.