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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309059763 Category : Medical Languages : en Pages : 177
Book 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)â€"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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309059763 Category : Medical Languages : en Pages : 177
Book 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)â€"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.
Author: Committee on Halcion: An Assessment of Data Adequacy and Confidence Publisher: National Academies Press ISBN: 0309591457 Category : Medical Languages : en Pages : 177
Book 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.
Author: Publisher: ISBN: Category : Languages : en Pages :
Book Description
Features information on Halcion, a treatment of insomnia, provided by New Media Systems, Inc. Discusses why the drug is prescribed, how to take the medication, side effects, possible food and drug interactions, and recommended dosages.
Author: Niels F. Muller Publisher: Elsevier Publishing Company ISBN: Category : Medical Languages : en Pages : 1388
Book Description
Hardbound. Many health care providers are frequently dealing with problems related to the identification and interpretation of medicines and prescriptions of foreign origin. Health authorities, customs and travel agencies also encounter such problems, which are related to the increasing mobility of the European population. Thus the need for a European Drug Index is obvious. The EDI provides extended information for practitioners confronted with the enormous number of drug names available on the European pharmaceutical market. This market is increasing due to the rapidly changing palette of countries and economic restrictions in Europe. The listings have been derived from drug data sources from the increased number of participating countries in this second edition. Each item starts with a trade name, in alphabetical order, followed by (depending on the original source) dosage forms, strength, volume (if applicable), and generic name(s) of the active princi
Author: John Abraham Publisher: Routledge ISBN: 1134195818 Category : Law Languages : en Pages : 231
Book Description
How do drugs get to the market? What controls are there and what procedures for monitoring their effects? And how adequate are the regulators in protecting public health when new drugs have serious side effects? The Therapeutic Nightmare tells the story of the sleeping pill Halcion - a story which is far from over. First marketed in the 1970s, Halcion has been taken by millions of patients around the world. For many years it has been associated with serious adverse effects such as amnesia, hallucinations, aggression and, in extreme cases, homicide. Thirteen years after its first release, it was banned by the British government. It remains on sale in the United States and many other countries. This book explains why patients have come to be exposed to Halcion's risks and examines the corporate interests of the manufacturers, the professional interests of the scientists and medical researchers and the interests of patients in safe and effective medication. It reveals how these contending forces shape the regulatory decision-making process about drug safety. As the number of new drugs and health products grows, a major challenge facing regulators and the medical profession is how to put the interests of public health decisively and consistently above the commercial interests of the drugs industry, while becoming more accountable to patient and consumer organizations.
Author: Juanne Nancarrow Clarke Publisher: Don Mills, Ont. : Oxford University Press ISBN: Category : Medical Languages : en Pages : 468
Book Description
Using four different sociological perspectives--structural-funcational, conflict, symbolic interactionist, and feminist--Health, Illness, and Medicine in Canada 4e provides an essential study to the sociology of health. The text examines occupational diseases, environmental challenges, the inequalities of age, gender, class, race, and ethnicity, the experience of getting sick and going to the doctor, and the extensive and profit-motivated impact of the pharmaceutical and medical device industries.
Author: Stephen M. Rosoff Publisher: ISBN: Category : Law Languages : en Pages : 538
Book Description
For courses in American Culture, White Collar Crime, Social Problems, Criminology, and Law & Society. The second edition of Profit Without Honor discusses and explains various types of white collar crimes in easily understood terms in an engaging and entertaining manner. The nature and extent of these acts are fully documented using academic and popular sources. The text also looks at the damage inflicted upon victims, and the larger society, its institutions and culture as a whole, showing it to be much greater than that of common crime.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Committee on Halcion: An Assessment of Data Adequacy and Confidence
Author: 
Author: Niels F. Muller
Author: John Abraham
Author: Juanne Nancarrow Clarke
Author: 
Author: Stephen M. Rosoff
Author: 
Author: