Description
Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.
About the PDF: What am I Buying?
About Our PDFs
This book can be purchased as a computer file. The format of the file is called a "PDF". To open, view and print the file, you must have third party software (e.g. Adobe Reader or XPDF) installed on your computer.
Benefits of Buying a PDF
-
Instant. Buy it, download it immediately, and start reading.
-
Convenient. Download it to your laptop and read it whenever, wherever.
-
Searchable. Search for any word or phrase.
What are my options?
| If you want ...
| Then ...
|
| ... a computer file containing the entire book |
... buy a PDF |
| ... to read the book immediately and also own a copy for your bookshelf |
... buy the bundle |
| ... a copy for your bookshelf |
... buy the book |
Will my PDF be emailed to me?
No. After buying the PDF, we will email you instructions on how to download the file from our Web site. The PDF file will not be emailed to you.
See our Frequently Asked Questions for more information including:
Items in cart [4]
