FDA committees support petition to switch Allegra, Claritin and Zyrtec to OTC

July 1, 2001

Pharmaceutical Representative

The Nonprescription Drugs and Pulmonary and Allergy Drugs Advisory Committees of the U.S. Food and Drug Administration have voted that the agency switch the allergy drugs Claritin® (loratadine), Allegra® (fexofenadine HCl) and Zyrtec® (cetirizine HCl) from prescription to over-the-counter status. The panel convened in response to a petition filed by Blue Cross of California, a subsidiary of Thousand Oaks, CA-based WellPoint Health Networks, requesting the switch.

The Nonprescription Drugs and Pulmonary and Allergy Drugs Advisory Committees of the U.S. Food and Drug Administration have voted that the agency switch the allergy drugs Claritin® (loratadine), Allegra® (fexofenadine HCl) and Zyrtec® (cetirizine HCl) from prescription to over-the-counter status. The panel convened in response to a petition filed by Blue Cross of California, a subsidiary of Thousand Oaks, CA-based WellPoint Health Networks, requesting the switch.

Claritin, Allegra and Zyrtec are manufactured by Schering-Plough Corp., Kenilworth, NJ; Aventis Pharma AG, Parsippany, NJ; and Pfizer Inc., New York, respectively.

The advisory panel looked at several criteria regarding the drugs' safety and effectiveness, including:


•Â Whether the drugs had a low incidence of significant side effects under adequate direction for use.


•Â Whether the drugs had warnings against unsafe use.


•Â Whether the drugs had a low potential for harm that might result from abuse under conditions of widespread availability.

The panel also looked at the effectiveness of the drugs in question to determine whether "in a significant portion of the target population, the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed."

Based on these criteria, the panel voted 19 to 4 for Claritin and Zyrtec and 18 to 5 for Allegra to recommend that the FDA allow the drugs to be sold over the counter.

"We are pleased and encouraged that the committees agreed with our assertion that these drugs are safer and as effective as the antihistamine drugs that are currently available OTC, and do not meet the FDA criteria for prescription status," said Robert Seidman, chief pharmacy officer at WellPoint.

Manufacturers disagree

Schering, Pfizer and Aventis have all opposed the switch, saying it will endanger patients by taking doctors out of the prescribing equation.

"We believe that prescription status of these medications is necessary to protect and optimize public health," said Robert Spiegel, chief medical officer of Schering-Plough.

Added Francois Nader, senior vice president of medical and regulatory affairs for Aventis: "While we are disappointed in the recommendation, we believe the panel discussion illuminated the complexity of this issue and the types of concerns that the FDA will now need to consider. In fact, the substance of the panel's debate pointed to the need for further evaluation of the likely impact of a switch on patients."

The FDA is not required to follow the panel's recommendation. PR

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