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Claritin Approved for Over-the-Counter Sales

Mark B. McClellan, commissioner of Food and Drugs, said, ”By making it easier to get this widely-used drug, today’s action will enable many people to get less-sedating, effective relief for their allergy symptoms more quickly and at a lower cost.”

“This approval reflects FDA’s commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.”

Claritin manufacturer Schering-Plough Corp. initially fought the switch, but changed its position as the drug’s December 2002 patent expiration date approached. After that date, the drug will be open to competition from generics.

The current prescription-only Claritin costs about $60 a month, plus the cost of a doctor’s visit to get a prescription. Schering-Plough Corp. didn’t immediately comment on what the over-the-counter version will cost, but in Canada, a month’s supply of nonprescription Claritin runs about $17.

People without insurance that covers medications will reap the benefits of any price decrease. But allergy sufferers accustomed to getting Claritin for the cost of an insurance co-payment may pay more once the drug is available over-the-counter.

The FDA’s action also means that when generic versions of Claritin debut next year, they, too, will sell without a prescription. These generics, if they follow the usual pattern for drug prices, may be marketed at a significantly lower price than their brand-name counterpart.

Meanwhile, some allergists are concerned that the change in Claritin’s status will cause insurance companies to block access to other prescription antihistamines — the prescription-only successor to Claritin called Clarinex and the competitors Allegra and Zyrtec.

Some patients who respond only to one drug could be left without alternative treatments if insurance coverage ends, Dr. William Berger, president of the American College of Allergy, Asthma and Immunology, told the Associated Press.

“The decisions are being made in the boardroom and not in the exam room as to what’s in the patient’s best interest,” said Berger, warning that such a move could extend far beyond allergy medications.

“Claritin OTC [over-the-counter] per se is not the issue,” Berger added. “We could be having the same conversation in six months when they decide not to cover … [the arthritis therapies] Vioxx or Celebrex and say just go buy some Advil.”

Last year, the FDA’s scientific advisers recommended that the agency move Allegra and Zyrtec to over-the-counter status along with Claritin. Those drugs’ manufacturers haven’t sought the change, but Blue Cross of California petitioned the FDA to force it. The FDA still is debating what to do, said Dr. Robert Meyer, the agency’s nonprescription drugs chief.

It is not clear how soon Claritin competitors Allegra and Zyrtec could sell without a prescription as well. Last year, the 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.

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