Open AccessAn epidemiologic postmarketing surveillance study of prescription acne medications.
Author(s) -
D. Facklam,
Jacqueline S. Gardner,
Gary L. Neidert,
Margaret M. Westland
Publication year - 1990
Publication title -
american journal of public health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.284
H-Index - 264
eISSN - 1541-0048
pISSN - 0090-0036
DOI - 10.2105/ajph.80.1.50
Subject(s) - medicine , acne , medical prescription , diarrhea , antibiotics , postmarketing surveillance , clindamycin , drug , adverse effect , pharmacy , dermatology , family medicine , pharmacology , microbiology and biotechnology , biology
After the Food and Drug Administration approved a topical antibiotic for the treatment of acne, we began a postmarketing surveillance study to measure the frequency of antibiotic-associated colitis and diarrhea in acne patients treated with topical antibiotics and low doses of oral antibiotics. Pharmacists recruited 13,465 patients who presented a prescription for an acne medication, and we obtained detailed information on the use of the medications, perceived acceptability, and the occurrence of new health events from 6,453 with computer-assisted telephone interviews. Three cases (less than 0.1%) of antibiotic-associated diarrhea and one case (less than 0.1%) of antibiotic-associated colitis were confirmed. We conclude that this methodology can provide further information about the safety of a drug once it is in customary use, at a fraction of the cost of Phase III clinical trials.