BRISTOL OTC QUESTRAN 90% LABEL COMPLIANCE IN STUDY IS DIFFICULT TO EXTRAPOLATE TO REAL WORLD, FDA REVIEWER SAYS; ADVISORY CMTES. SPLIT ON OTC SUITABILITY

An "actual use" study of over-the-counter Questran (cholestyramine) showed that 90% of subjects complied with the label by consulting a physician before using the drug or by opting not to use the drug, Bristol-Myers Squibb reported at a May 13 joint meeting of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees. The groups met to consider whether Questran and Questran Light Rx treatments for hypercholesterolemia are appropriate candidates for OTC marketing.