Document Detail


Safety of doxycycline and minocycline: a systematic review.
MedLine Citation:
PMID:  16291409     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The goal of this review was to summarize the available literature covering the safety profiles of oral doxycycline and minocycline. METHODS: Scientific literature published between 1966 and August 2003 was searched using the MEDLINE, EMBASE, and Biosis databases (search terms: minocycline or doxycycline, each paired with adverse reaction, adverse event, and side effect, and doxycycline or minocycline with the limits English language, human, and clinical trials). Safety information was collected from case reports and clinical trials. Adverse event (AE) rates in the United States were calculated by comparing data from the MedWatch AE reporting program used by the US Food and Drug Administration (FDA) with the number of new prescriptions dispensed for each drug from January 1998 to August 2003. RESULTS: Between 1966 and 2003, a total of 130 and 333 AEs were published in case reports of doxycycline and minocycline, respectively. In 24 doxycycline clinical trials (n = 3833) and 11 minocycline trials (n = 788), the ranges in incidence of AEs were 0% to 61% and 11.7% to 83.3%, respectively. Gastrointestinal AEs were most common with doxycycline; central nervous system and gastrointestinal AEs were most common with minocycline. From January 1998 to August 2003, the FDA MedWatch data contained 628 events for doxycycline and 1099 events for minocycline reported in the United States. Approximately 47,630,000 doxycycline and 15,234,000 minocycline new prescriptions were dispensed in the United States during that period, yielding event rates of 13 per million for doxycycline and 72 per million for minocycline, based on FDA data. CONCLUSIONS: Between 1998 and 2003, doxycycline was prescribed 3 times as often as minocycline. The incidence of AEs with either drug is very low, but doxycycline had fewer reported AEs. Although more head-to-head clinical trials are needed for a direct comparison of AE frequency, these preliminary data from separate reports suggest the possibility that AEs may be less likely with doxycycline than minocycline.
Authors:
Kelly Smith; James J Leyden
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Clinical therapeutics     Volume:  27     ISSN:  0149-2918     ISO Abbreviation:  Clin Ther     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-11-18     Completed Date:  2006-11-13     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7706726     Medline TA:  Clin Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1329-42     Citation Subset:  IM    
Affiliation:
Warner Chilcott Laboratories, Rockaway, NJ 07866, USA. ksmith@wclabs.com
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MeSH Terms
Descriptor/Qualifier:
Acne Vulgaris / drug therapy
Adverse Drug Reaction Reporting Systems
Anti-Bacterial Agents / adverse effects*,  therapeutic use
Central Nervous System Diseases / chemically induced,  epidemiology
Clinical Trials as Topic
Doxycycline / adverse effects*,  therapeutic use
Drug Prescriptions
Gastrointestinal Diseases / chemically induced,  epidemiology
Humans
Incidence
MEDLINE
Minocycline / adverse effects*,  therapeutic use
Skin Diseases / chemically induced,  epidemiology
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 10118-90-8/Minocycline; 564-25-0/Doxycycline

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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