FDA panel backs nonprescription Claritin for hives

WASHINGTON (CNN) -- A panel of doctors and scientists that advises the Food and Drug Administration recommended Monday that the popular allergy drug Claritin be sold over the counter for treatment of chronic hives.

The decision now rests with the FDA, which usually follows advisory recommendations. If approved, the voluntary drug reclassification eventually should mean lower prices for consumers.

Claritin's maker, New Jersey-based Schering-Plough Corp., wants to release three Claritin products -- Claritin tablets, Claritin RediTabs and Claritin syrup, all at the current 10-milligram dosage -- as over-the-counter products for hives.

Claritin would be the first nonprescription medication marketed for chronic hives in the United States.

Claritin has been approved for over-the-counter allergy relief and hives in 33 countries, including Canada and the United Kingdom. Canadians pay about $11 for a month's supply, compared with an average $17 monthly co-payment for U.S. patients with insurance coverage.

In its FDA advisory panel appearance Monday, Schering-Plough presented four studies to support its request for an over-the-counter Claritin hive treatment. The panel reviewed consumer practices, physician habits, a study on whether people with hives can adequately recognize the condition and a report on how well consumers understand labels.

Monday marked the second time in less than a year Schering-Plough has come before the advisory committee to discuss over-the-counter status for Claritin.

In an unprecedented move to cut prescription drug costs, WellPoint Health Networks Inc., a California health maintenance organization, petitioned the FDA to make three popular antihistamines -- Claritin, Aventis' Allegra and Pfizer's Zyrtec -- available over the counter. FDA advisers recommended last year that the three drugs could be sold without prescription for allergy relief.

Originally opposed to the reclassification, Schering-Plough announced in March that it would make Claritin available for treatment of seasonal allergies without prescription.

The FDA is likely to approve Claritin as an over-the-counter allergy relief by November, if not sooner.

There are an estimated 45 million allergy sufferers in the United States.

Should the FDA approve the use of over-the-counter Claritin to treat hives first, the manufacturer won't be able to keep consumers from also using it for allergy relief.