This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Social Bookmarking   What's this?

1984-1989

Gerald A. Faich, MD, MPH

Arch Intern Med. 1991;151(8):1645-1647.

Abstract
Surveillance of adverse reactions due to pharmaceuticals is important because the drug approval process cannot totally assure safety and because new knowledge is bound to accrue after drugs enter usual medical practice. Reporting of reactions to the Food and Drug Administration increased markedly between 1985 and 1989 and totaled 261 515 reports for this period. A large part of this increase was due to new legal requirements, which ensure that manufacturers report reactions to the Food and Drug Administration. Most reaction reports originated with practicing physicians who contacted drug manufacturers. High proportions of the reports involved new drugs and serious reactions. Reaction surveillance leads to 50 to 100 important safety investigations annually and to numerous changes in product information. Health care providers must continue to report suspect adverse reactions to the Food and Drug Administration and manufacturers if pharmaceutical use and safety are to improve.

(Arch Intern Med. 1991;151:1645-1647)

Author Affiliations
From the Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md. Dr Faich is now with the Philadelphia Association for Clinical Trials, St Davids, Pa. The opinions expressed are those of the author and do not necessarily reflect the Food and Drug Administration policy.

Footnotes
Accepted for publication February 18, 1991.

Reprint requests to Suite D200, 150 Radnor-Chester Rd, St Davids, PA 19087 (Dr Faich).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Safety and Tolerability of Topiramate in Children
Levisohn
J Child Neurol 2000;15:S22-S26.
ABSTRACT  

Patient Risk Factors for Adverse Drug Events in Hospitalized Patients
Bates et al.
Arch Intern Med 1999;159:2553-2560.
ABSTRACT | FULL TEXT  

Identifying Adverse Drug Events: Development of a Computer-based Monitor and Comparison with Chart Review and Stimulated Voluntary Report
Jha et al.
J. Am. Med. Inform. Assoc. 1998;5:305-314.
ABSTRACT | FULL TEXT  

Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention
Bates et al.
JAMA 1995;274:29-34.
ABSTRACT  

Postmarketing Surveillance: Beyond medWatch
Faich
JAMA 1993;270:2180-2180.
ABSTRACT