FDA panel recommends OTC status for Prilosec. (Vote Was 16-2 in Favor).

BETHESDA, MD. -- Prilosec should be approved for sale as an over-the-counter drug, experts recommended at a joint meeting of the Food and Drug Administration's Nonprescription Drugs and Gastrointestinal Drugs Advisory committees.

Prilosec (omeprazole) is manufactured by AstraZeneca, but the over-the-counter (OTC) marketing rights were sold to Procter & Gamble. The drug is indicated for the prevention of frequent heartburn symptoms. The recommended dose is a 20-mg tablet, taken in the morning for 14 consecutive days. Prilosec is a proton pump inhibitor and would be the first in that class of drugs to obtain OTC status.

Despite reservations, committee members voted 16-2 in favor of OTC status. The FDA is not obliged to follow the recommendations of these committees, but the agency usually does.

Several advisory committee members expressed concern that consumers would repeatedly use Prilosec in lieu of consulting with a physician for recurrent heartburn.

This could delay treatment of more serious diseases, such as esophageal adenocarcinoma or erosive esophagitis.

"The majority of people with frequent heartburn see a doctor for their symptoms, and the actual use trial suggests that physician visits will not decrease and may increase with OTC omeprazole," said Dr. Nora Zorich, vice president of pharmaceuticals at Procter & Gamble.

The majority of panel members criticized as inadequate the suggested OTC labeling and were concerned that low-literacy consumers might not understand the labeling, particularly its warnings.