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`Page 1 of 2
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`Archives
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` 1997
`The Hazards of Seldane
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`JAN. 17, 1997
`Allergy sufferers who take Seldane could easily be confused by recent actions of the
`Food and Drug Administration. Less than two weeks after the agency approved a
`generic form of the popular antihistamine, the agency has moved to take the original
`drug off the market. But the proposed ban against Seldane comes after years of
`warnings about its potential hazards. Removing it from the market is thoroughly
`justified.
`Introduced in 1985, Seldane was the first prescription antihistamine to relieve
`symptoms of allergies like sneezing, itching and runny nose without causing
`drowsiness. But within a few years, serious problems were reported. When taken
`with certain antibiotics and anti-fungal drugs, Seldane apparently could trigger
`irregular heart rhythms.
`Over the years the F.D.A. received about 40 reports of serious heart rhythm
`abnormalities, evidently caused by Seldane, that led to eight deaths. But the agency,
`which is supposed to insure that drugs are safe and effective, felt that Seldane should
`remain on the market because, for a time, it was the only such drug available and
`because the benefits of an antihistamine that did not cause drowsiness, a potential
`hazard itself, were thought to outweigh the risks.
`The F.D.A. issued warnings to doctors about potential side effects when Seldane
`was simultaneously prescribed with other drugs. Additional warnings to doctors,
`pharmacists and the public came from Seldane's manufacturer, Hoechst Marion
`
`https://www.nytimes.com/1997/01/17/opinion/the-hazards-of-seldane.html
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2041, Page 1
`
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`The Hazards of Seldane - The New York Times
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`Page 2 of 2
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`Roussel. But while dangerous incidents have decreased, they have not been
`eliminated.
`Last July Hoechst Marion Roussel received F.D.A. approval to market another
`antihistamine, called Allegra, which consists of the primary active derivative of
`Seldane. Since Allegra does not pose the same risk of abnormal heart rhythms, it
`could easily be substituted for Seldane, but the agency wanted to be certain that no
`other serious risks became evident after widespread use of Allegra.
`After nearly six months on the market, Allegra has not presented any surprises.
`But in a classic bureaucratic coincidence, as the new drug was being marketed, an
`application for a generic form of Seldane made it through the agency's drug approval
`apparatus and was routinely approved earlier this month.
`Now, deeming the trial period for Allegra sufficient, the F.D.A. proposes to ban
`both Seldane and its generic substitute. The manufacturers have 30 days to respond,
`and the hearing process could last a year as both sides present scientific evidence.
`Hoechst Marion Roussel has indicated that it will fight the ban, challenging the
`agency's judgment on the safety of Seldane. That may be an understandable business
`strategy, but the better public health strategy would be to market Allegra more
`aggressively and let Seldane be withdrawn more quickly.
`The TimesMachine archive viewer is a subscriber-only feature.
`
`We are continually improving the quality of our text archives. Please send feedback,
`error reports, and suggestions to archive_feedback@nytimes.com.
`
`A version of this editorial appears in print on January 17, 1997, on Page A00030 of the National edition
`with the headline: The Hazards of Seldane.
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`© 2019 The New York Times Company
`
`https://www.nytimes.com/1997/01/17/opinion/the-hazards-of-seldane.html
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2041, Page 2
`
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