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GAITHERSBURG, Md. — Three popular allergy medications are safe enough to be sold without prescription, a federal advisory panel ruled Friday in an unprecedented case that could save the health insurance industry billions of dollars but increase costs for many consumers. 

Acting on a petition by WellPoint Health Networks of Thousand Oaks, the Food and Drug Administration panel recommended that Claritin, Allegra and Zyrtec be made available over the counter, without supervision by a doctor. 

The vote was 19-4 each for Claritin and Zyrtec, and 18-5 for Allegra. The FDA is not required to follow the recommendations of the panel, but usually does so. 

Dr. John Jenkins of the FDA said he did not have a timeframe for a decision in the “very unusual” case. Traditionally drug companies, not insurance companies, ask for a change, he said. 

WellPoint, which could save $45 million a year, had argued that the allergy medications were safe. 

“There is no clinical reason for Claritin, Allegra and Zyrtec to be maintained as prescription drugs,” Robert Seidman, a company vice president, told the 23-member panel. “They have side effects similar to a sugar pill.” 

Drug companies countered that the move would force consumers into a “risky trial-and-error gamble with their health, their quality of life and their money.” People will self-diagnose and treat conditions that need the attention of a doctor, company executives said. 

“Insurance companies see a physician visit as a cost item,” said Dr. Robert J. Spiegel, vice president of Schering-Plough, maker of Claritin. “We see it as an essential part of health care. Now is not the time to drive patients farther away from their physicians.” 

The company said later in a statement that an FDA change without pharmaceutical makers’ support would be a reversal of past agency policy and could create legal questions. 

The financial implications of the FDA’s decision will be huge for the insurance industry, drug manufacturers and consumers. 

Consumers with insurance would have to pay the full cost. Those without insurance may pay less if the drug companies lower prices to meet competition, which some experts expect. 

Last year, the three drugs generated about $4.7 billion in sales. 

The drugs can sell for more than $2 a pill. With a prescription, a patient with insurance can get a month’s supply at the personal cost of a copay charge, perhaps as little as $5. The insurance company then has to pay the balance, $50 to $60. 

If the drugs are reclassified as over the counter, insurance companies would no longer have to pay for them. 

Mike Bernstein, a Washington-based food and drug attorney, said if there is a change, the three drug companies could be forced to compete with other over-the-counter cold, flu and allergy medications, most of which are cheaper than prescription drugs. 

In Canada, Claritin can be purchased at stores without prescriptions for significantly less than the U.S. price. Seidman said the cost there is about $11 a month and that the companies should also have competitive prices in America. 

Jenkins said the FDA cannot force the companies to continue selling the drugs. 

Inappropriate self-treatment could have serious medical consequences, said Dr. Francois Nader, vice president of Aventis Pharma AG, maker of Allegra. 

“Consumers would face a risky trial and error gamble with their health, their quality of life and with their money,” he said. 

Manufacturers pointed to asthma, a serious respiratory condition, as a disease that patients might try to treat without seeing a doctor. 

Nader said WellPoint is pushing for declassification because it does not pay for over-the-counter drugs and the change could save the company millions of dollars. But he predicted that “the short term gain to the insurers would increase the health care burden” on society. 

Pfizer Incorporated, maker of Zyrtec, did not make a presentation at the meeting. 

The allergy drugs are known as second generation antihistamines because they dry up allergy symptoms without causing drowsiness so common with first generation over-the-counter drugs. 

Claritin was approved in 1993, Zyrtec in 1995 and Allegra in 1996. 

In response to the decision, shares of Schering-Plough finished trading on the New York Stock Exchange up $1.20 to $38.20. Shares of Aventis fell $1.22 to $75.53, while Pfizer was off 74 cents to $43.00. 

Dr. Robert Meyer, of the FDA, told the panel that there have been only a few instances of heart and kidney problems and seizures among patients taking the drugs, but there is no clear indication that these adverse events were directly caused by the medication. 

In his presentation, Seidman said that second generation antihistamines are now on sale without a prescription in 17 countries. He said U.S. consumers could save money they now spend for doctors visits to get prescriptions. 

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On the Net: Food and Drug Administration: http://www.fda.gov