Panel recommends selling allergy drugs OTC

GAITHERSBURG, Maryland (CNN) -- An advisory committee to the U.S. Food and Drug Administration voted Friday that three popular allergy drugs are safe enough to be used without a prescription.

The votes were 19-4 for Claritin and Zyrtec, and 18-5 for Allegra, an FDA spokesman said.

The votes are not binding. The FDA does not have to follow the advice of its advisory committee, though it usually does. There is no deadline for making a decision.

The review was undertaken at the request of WellPoint Health Networks, formerly Blue Cross of California, which is seeking the change because insurers typically do not pay for over-the-counter drugs.

If the FDA goes along with its advisory committee's recommendations, patients would have to pay the full cost of the drugs, rather than receiving at least partial reimbursement from their insurance carriers.

"Drugs are prescription for a reason," said Robert Seidman, WellPoint's chief pharmacy officer. "They have the ability to do both good and harm. Claritin, Allegra and Zyrtec have almost no side effects and are equally effective as the antihistamines that are available over the counter today."

Anti-allergy medications have been linked to side effects in some users that include reduced alertness, nausea and headache. By prescription, the drugs cost about $80 per month versus $10 to $15 in the 17 nations where the drugs are over-the-counter, he said.

The drug makers oppose a switch, which would cost them money.

"We strongly believe Claritin should remain a prescription product," said Schering-Plough spokesman Robert Consalvo. "Prescription status is necessary to protect the public health. To switch would force patients to self-diagnose, self-treat and pay the entire cost." Additional information is needed on the effects of such a switch, he said.

Usually, drug companies support making a drug over-the-counter only when their patent is about to run out, because doing so at that time extends the period during which makers of generic drugs are prohibited from selling lower-priced versions of the drug. Claritin's patent is due to expire in 2002, but the company is waging a multi-million-dollar campaign in Congress to get it extended.

Aventis Pharmaceuticals, which manufactures Allegra, also expressed its disappointment.

"While we are disappointed in the recommendation, we believe the panel discussion illuminated the complexity of this issue and the types of concerns the FDA will now need to consider," said Dr. Francois Nader, an Aventis senior vice president.

According to WellPoint, sales of Allegra, Claritin and Zyrtec exceeded $5 billion last year.