FDA Mulls Allergy Drug Change

May 7 -- The Food and Drug Administration is considering a request by an insurance company to make three of the most popular allergy drugs available over the counter — against the will of the drugs' manufacturers.

The drugs — Claritin, Allegra and Zyrtec — are currently available by prescription only, so their cost is covered by insurance. Selling them over the counter would make them more easily available, but allergy sufferers would have to pay for the drugs themselves.

The insurer that petitioned the FDA, WellPoint Health Networks, currently spends $45 million a year on claims for the three allergy drugs.

"They add an incredible financial burden to the entire health-care system," said Robert Seidman, vice president of pharmacy for WellPoint.

That burden would shift to the allergy sufferer if the drugs were no longer sold by prescription.

"These products will still cost a lot when they are over the counter," said Ira Loss, a pharmaceutical industry investment expert with Washington Analysis Corp. "They may cost less than they do now, but it's going to cost the consumer a whole lot more out of his own pocket."

Safety Issues

The manufacturers of the three drugs — Schering-Plough, which makes Claritin; Pfizer, which makes Zyrtec; and Aventis, maker of Allegra — oppose the change. Although their advertising stresses the drugs' safety, the companies argue that selling the medicines over the counter will not be as safe as prescribing them.

In a document filed with the FDA, Schering-Plough says there is no guarantee that "equivalent safety would exist … without a physician's care."

Dr. Henry Fishman, an allergist who prescribes allergy drugs to his patients in the Washington, D.C., area, agrees.

"It is not simply a matter of a little stuffy nose and take a pill," he said. "Allergies are chronic illnesses. They lead to sinus troubles, ear infections, and are associated with asthma."

The drugmakers spend millions on ads that emphasize the safety and ease of taking their allergy pills. "Claritin has a low occurrence of side effects such as headaches, drowsiness, fatigue and dry mouth — similar to a sugar pill," one Claritin commercial on television claims.