WASHINGTON -- The government approved over-the-counter sales of the popular allergy remedy Claritin on Wednesday, a long-anticipated move that will save uninsured allergy sufferers money but prove more costly to those with prescription drug insurance plans.
The decision comes four years after a prominent insurance company petitioned the Food and Drug Administration to force Claritin's maker to sell it without a prescription here just like it long has in Canada.
Money aside, proponents of the switch argued that nondrowsy Claritin is safer than today's over-the-counter antihistamines that make people sleepy, very dangerous if they're driving.
Manufacturer Schering-Plough Corp. vehemently fought the switch at first, saying the insurance industry pushed the change because it doesn't pay for over-the-counter medicines - meaning insurers will save billions in drug costs as well as doctor fees.
But Claritin's patent expires in December, opening the drug to generic competition - so earlier this year, Schering grudgingly changed course and asked the FDA to allow Claritin to be sold next to the aspirin and cough syrup after all.
Today's prescription-only Claritin costs about $60 a month, plus the cost of a doctor's visit to get a prescription. Schering didn't immediately say what the over-the-counter version will cost, but in Canada, a month's supply of nonprescription Claritin is about $17.
For people without insurance that covers medications, that's a boon. But allergy sufferers used to a $10 or so insurance co-payment for their drugs would start paying more.
The FDA's action also means that when generic versions of Claritin debut next year, they, too, will sell without a prescription - and generic drugs usually are significantly cheaper than their brand-name counterparts.
Not clear is how soon Claritin competitors Allegra and Zyrtec could sell without a prescription as well. Last year, FDA's advisers recommended the agency take that step, ruling that all three of the non-sedating antihistamines were equally safe for over-the-counter sales.
The FDA still is debating the fate of Allegra and Zyrtec, said Dr. Robert Meyer, the agency's nonprescription drugs chief.
Schering in January also began selling a prescription-only successor to Claritin called Clarinex. But Clarinex isn't considered much of an improvement over the older drug, so insurance companies may not reimburse patients for the more expensive prescription remedy.
Analysts predict the Claritin switch will mean revenue from the company's top-selling drug will shrivel, from worldwide sales of $3.1 billion last year to likely under half a million next year.
Some 40 million Americans have allergies, and half of them are estimated to use over-the-counter remedies.
Claritin's main advantage over the other nonprescription choices is that it's not sedating - it won't carry that warning against driving or operating heavy machinery that's so common on over-the-counter drugs.
But anyone who takes higher-than-recommended doses of Claritin, or has kidney or liver disease that slows metabolism of the drug, can experience some drowsiness, Meyer cautioned.