An epidemiologic postmarketing surveillance study of prescription acne medications.
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.
Facklam
D P
DP
Medication Monitoring Program, Upjohn Company, Kalamazoo, MI 49001.
Gardner
J S
JS
Neidert
G L
GL
Westland
M M
MM
D000152:Acne Vulgaris / Q000188:drug therapy*; D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003092:Colitis / Q000139:chemically induced*; D003967:Diarrhea / Q000139:chemically induced*; D004812:Epidemiologic Methods; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D011256:Pregnancy Outcome; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012737:Sex Factors
D000900:Anti-Bacterial Agents