OTC Prilosec to hit stores.(Concerns Remain)

The Food and Drug Administration has approved over-the-counter sales of Prilosec, and the drug is slated to hit store shelves nationwide this fall.

Although the use of omeprazole (Prilosec) results in very few side effects, some physicians expressed concern about consumers self-medicating serious disorders and about the potential loss of omeprazole and other proton pump inhibitors (PPIs) from health-plan formularies.

Prilosec OTC, which will be sold in the same 20-mg strength as the prescription medication, is made by AstraZeneca and will be marketed by Procter & Gamble. The FDA required that the product's label indicate that it is not for use in treating infrequent heartburn (once per week or less) or for immediate heartburn relief. The label will warn consumers not to take a 14-day course of Prilosec OTC more than once every 4 months unless directed to do so by a physician.

On the plus side, "It's an extraordinarily safe drug," Dr. Kenneth R. DeVault, a gastroenterologist at the Mayo Clinic, Jacksonville, Fla., said in an interview. According to a spokesperson for Procter & Gamble, Prilosec OTC is expected to cost $1 a day or less, about one-third the price ...