FDA Panel Split Over OTC Questran Approval

A US Food and Drug Administration Nonprescription Drugs AdvisoryCommittee was divided five-five, with one abstention, over the suitability of switching Bristol-Myers Squibb's cholesterol-lowering medication Questran (cholestyramine) from prescription to over-the-counter status.

When the panel was asked whether hypercholesterolemia should be treated OTC, the vote was 7-4 against. Two years ago, the panel unanimously rejected B-MS' request to move the drug to OTC status, and also asked the company to prove that such a move would not keep those with high cholesterol away from the physician.

OTC Concerns "Paternalistic" In a trial of almost 3,000 people, B-MS found that only 1% of those who bought Questran did not follow up with a physician, according to FDA OTC chief Debra Bowen, who added that there were no serious side effects associated with the use of Questran.