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Examples

  • Dr. Peter Mendelis, a researcher at the FDA, tracked Halcion's adverse-reaction reports during its first year on the U.S. market, and he perceived a troublesome pattern.

    Sweet Dreams Or Nightmare?

  • FDA advisory committee votes to strengthen Halcion's package warning for amnesia but finds no need for further measures. 1990: FDA analysts compare numbers of violent acts associated with 329 prescription drugs.

    Sweet Dreams Or Nightmare?

  • After seeing a television magazine show in which Cincinnati pharmacologist Martin Scharf described Halcion's possible side effects, Petty grew more convinced that the drug had fueled his middle-of-the-night rage.

    Sweet Dreams Or Nightmare?

  • In 1989 Dr. Theresa Woo, the medical review officer handling Halcion's application, wrote a series of evaluation recommending against approval.

    Sweet Dreams Or Nightmare?

  • There was nothing about the patients, nothing about the circumstances in which the drugs were prescribed, nothing about the reporting practices of the manufacturers that could account for Halcion's higher rates.

    Sweet Dreams Or Nightmare?

  • For the next few years FDA staffers Diane Wysowski and David Barash compared Halcion's adverse-reaction reports with the reports for two other benzodiazepines, Dalmane and Restoril.

    Sweet Dreams Or Nightmare?

  • Upjohn may believe such reactions are flukes, no more likely with one benzodiazepine than another, but the company has never convincingly explained Halcion's remarkable ability to generate weird stories.

    Sweet Dreams Or Nightmare?

  • Halcion's high complaint rate wasn't unique to the United States.

    Sweet Dreams Or Nightmare?

  • Halcion's critics say there is no question it poses special hazards.

    Sweet Dreams Or Nightmare?

  • Many of Halcion's horror stories involve patients who were prescribed excessive doses -- and who were kept on the drug long after they should have been taken off.

    Sweet Dreams Or Nightmare?

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