Results 181 to 190 of about 600,809 (212)

Pemoline Hepatotoxicity and Postmarketing Surveillance

Journal of the American Academy of Child & Adolescent Psychiatry, 2001
To review the numerous reports of hepatotoxic adverse drug reactions (ADRs) ascribed to pemoline that were sent to the U.S. Food and Drug Administration (FDA) between 1975 and 1996 and to describe the medical community's lack of awareness of these reports.All ADR reports from 1975 through 1996 wherein pemoline was the suspect agent were obtained from ...
Julie Magno Zito, Daniel J. Safer, James F. Gardner   +2 more
openaire   +3 more sources

Postmarketing Safety Surveillance

Pharmaceutical Medicine, 2010
Management of spontaneous reports remains one of the most important activities in postmarketing surveillance. Increasingly, spontaneous reporting data are publically available, particularly following the criticism from the European Ombudsman over data secrecy by the European Medicines Agency in August this year. New legislation in the EU could mean the
Brian Edwards, Upasana Prabhakar
openaire   +2 more sources

Postmarketing Surveillance of the Safety of Cyclic Etidronate

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 1998
To evaluate the safety of cyclic etidronate in routine clinical practice, we obtained information from 550 general practices in the United Kingdom that provide the medical records to the General Practice Research Database. A group of 7977 patients taking cyclic etidronate and two age‐, gender‐, and practice‐matched control groups, one with osteoporosis
Lucien Abenhaim, Cyrus Cooper, Hubert G. M. Leufkens, Tjeerd van Staa   +3 more
openaire   +4 more sources

Postmarketing Surveillance of Quinolones, 1990 to 1992

Drugs, 1993
During the last 2 years, the major event in the postmarketing surveillance of quinolones has been the worldwide withdrawal of temafloxacin after only 15 weeks on the USA market. The Adverse Drug Reaction (ADR) reports that led to the withdrawal have been reviewed and show that the frequency and type of ADR and serious ADR were highly unusual in ...
Thomas M McDonald, Peter Davey
openaire   +3 more sources

Postmarketing Surveillance in Japan

Drug Information Journal, 1994
In April 1993, the Japanese Ministry of Health and Welfare (MHW) implemented an official guideline on good postmarketing surveillance (PMS) practice. This paper outlines the guideline, which calls for the establishment of a PMS department within each pharmaceutical company and enables the MHW to conduct inspections.
openaire   +2 more sources

Postmarketing Surveillance: Beyond medWatch

JAMA: The Journal of the American Medical Association, 1993
To the Editor. —As one who has actively participated in adverse effects surveillance over the past 10 years, 1,2 I wish to applaud the new Food and Drug Administration (FDA)MEDWATCHinitiative. 3 The FDA commissioner and his staff are to be congratulated on recognizing that major efforts must be made to heighten awareness of the importance of reporting
openaire   +3 more sources

Postmarketing Drug Surveillance-Reply

JAMA: The Journal of the American Medical Association, 1984
In Reply.— We agree with the views of Dr Borden and colleagues regarding the role of spontaneous reporting in a multicomponent postmarketing surveillance system. Moreover, we share, in large measure, their perception of the purpose of systematic surveillance. Nevertheless, we would like to take this opportunity to comment further on the purpose of our
Allen C. Rossi, Cheryl F. Graham, Deanne E. Knapp, Robert T. O'Neill, George R. Stanley, Peter S. Mendelis, Charles Anello   +6 more
openaire   +2 more sources

Postmarketing surveillance study of nateglinide in Japan

Advances in Therapy, 2005
Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice.
Takako Iso, Kenji Iwamoto, Hiroto Taki, Toshio Maki, Taiichi Kajiura   +4 more
openaire   +3 more sources

Patient Drug Attributions and Postmarketing Surveillance

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 1994
Although studies have shown that patients can distinguish probable adverse drug reactions (ADRs) from adverse clinical events (ACEs) caused by other factors, it is not known whether these attribution judgments add any independent validity to other accepted methods of identifying ADRs, such as physician assessments or epidemiologic data.
Thomas A. Kent, Jesse E. Davis, Seymour Fisher, Stephen G. Bryant   +3 more
openaire   +3 more sources

Postmarketing Surveillance (PMS)

1985
The term postmarketing surveillance should convey the meaning that the use of a drug after marketing is surveyed both for efficacy and safety; however, as the term is currently used, the emphasis is on safety rather than efficacy. One of the reasons for the lack of emphasis on efficacy has been the fact that the originating pharmaceutical company will ...
openaire   +2 more sources