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Chain Drug Review - Battle over Clarinex switch

admin — Mon, 12 Jan 2009 23:56:02 +0000

WASHINGTON–The National Consumers League (NCL) wants the Food and Drug Administration to keep Clarinex as a prescription-only product. The medication reached the market in January.
Earlier this year WellPoint Health Networks Inc. filed a petition with the regulatory agency to gain approval for an over-the-counter version of the Schering-Plough Corp. allergy product.
“The consequence of this forced O-T-C shift along with other NSAs that WellPoint has petitioned on would be to eliminate the insurance coverage for the entire class of nonsedating antihistamines, reduce allergy patient contact with their physicians and most likely encourage considerable numbers of allergy patients to choose cheaper sedating antihistamines,” NCL president Linda Golodner warned in a letter last month to the FDA.

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WellPoint has acknowledged it will stop paying for prescription allergy drugs if an O-T-C alternative becomes available and will only cover the prescription drug if a physician explains why a patient can not be treated with an over-the-counter antihistamine.
“Forcing Clarinex to join Claritin O-T-C would remove this choice for consumers and potentially sever important patient-physician ties,” Golodner says in her letter.
In addition, she points out that the FDA normally waits a minimum of five years before switching a newly approved drug to O-T-C status and that to do so prematurely would establish a dangerous precedent, because there would be no significant experience with the product in a large population group under the supervision of physicians.
“Given the FDA’s recent experience in withdrawing approvals for several drugs after severe reactions or side effects were revealed in large population use, NCL believes the FDA should not place consumers at risk by moving Clarinex O-T-C before it has had sufficient market experience,” comments Golodner.
“Continued physician oversight is crucial,” she says.
Finally, the NCL fears that increased use of sedating antihistamines would raise the risk of work-based accidents and injury, increase absenteeism and reduce productivity, and potentially impair the performance of many children in school.
WellPoint’s action regarding Clarinex came about a year after the company, a health maintenance organization based in Thousand Oaks, Calif., spearheaded a campaign to convince the FDA to move Claritin, Schering-Plough’s older allergy drug, to nonprescription status.
The HMO asserts that Clarinex is safe to move because of its similarity to Claritin.
But Schering-Plough opposes the latest WellPoint petition, asserting that a switch of nondrowsy antihistamines would impede the physician-patient relationship. In addition, it believes such a change should not be made without the consent of the drug’s sponsor.
Initially Schering-Plough also opposed an O-T-C form of Claritin, but it later rescinded that strategy and asked the FDA to permit sales of the product without a prescription. Health experts say an FDA decision is imminent.
Claritin, which loses its patent protection at the end of this year, has previously been granted O-T-C status as a treatment for recurring hives.
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Chain Drug Review - Schering-Plough gets okay to sell clarinex for allergies

admin — Wed, 07 Jan 2009 23:46:02 +0000

KENILWORTH, N.J. — Schering-Plough Corp. bas received Food and Drug Administration approval of Clarinex (desloratadine) for the treatment of seasonal allergic rhinitis (SAR).
The product builds upon the company’s heritage as a discoverer and developer of allergy and respiratory products as demonstrated by the success of its Claritin collection of nonsedating antihistamines and by Nasonex, a once-daily nasal steroid for allergies.
Clarinex is designed to provide 24-hour relief of nasal and nonnasal symptoms of seasonal allergies.
Cleared in the form of 5-mg. tablets, the product, known by its generic name of desloratadine, is for use by patients 12 and older.

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