FDA Committee Says OK to OTC Claritin

G A I T H E R S B U R G , Md., May 11 -- A Food and Drug Administration advisorypanel recommended today that the popular allergy drugs Claritin,Allegra and Zyrtec be made available without prescription.

The votes came on a request by a California health insurancecompany, which said the medications were safe and could be used bypatients without consulting doctors. Considering the question of whether the drugs were safe forover-the-counter sales, the panel voted 19-4 for Claritin, 18-5 forAllegra and 19-4 for Zyrtec. The FDA is not required to follow the panel's recommendations,but usually does so.

Insurers: Consumers Can Self Medicate

Executives of two drug companies said it would be premature toswitch these allergy medicines to over-the-counter pills. The drugs sell for about $2 a pill. With a prescription, apatient with insurance can get a month's supply at the personalcost of a copay charge, perhaps as little as $5. The insurancecompany then has to pay the balance, $50 to $60.

If the drugs are reclassified as over-the-counter, insurancecompanies would no longer have to pay for them. By some estimates,Wellpoint Health Networks of Thousand Oaks, Calif., which filed thepetition, could save $45 million a year if all three medicationswere made over-the-counter. Robert Seidman, vice president of Wellpoint, told the panel thatClaritin, Allegra and Zyrtec are safer than the currentover-the-counter antihistamine drugs that cause drowsiness. "There's no clinical reason for these drugs to be maintained asprescriptions," Seidman said. "Patients can readily self-diagnoseand patients can safely use these drugs."

Drug Co.'s: Patients At Risk

But Dr. Francois Nader, vice president of Aventis Pharma AG,which makes Allegra, said switching the drugs would be"inappropriate and potentially adverse to human safety." Although Allegra is safe when prescribed by physicians, he said,there is not enough information to ensure the safety would bemaintained if patients were to self-diagnose and self-medicate.