Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin

Pharmacoepidemiol Drug Saf. 2013 Dec;22(12):1258-62. doi: 10.1002/pds.3514. Epub 2013 Sep 22.

Authors

Kevin Fain¹, G Caleb Alexander

Affiliation

¹ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD, USA.

PMID: 24115318
DOI: 10.1002/pds.3514

No abstract available

Publication types

Research Support, U.S. Gov't, P.H.S.
Comment

MeSH terms

Abnormalities, Drug-Induced / prevention & control*
Contraceptive Agents / administration & dosage*
Dermatologic Agents / administration & dosage*
Dermatologic Agents / adverse effects*
Drug Utilization / trends*
Female
Humans
Isotretinoin / administration & dosage*
Isotretinoin / adverse effects*

Substances

Contraceptive Agents
Dermatologic Agents
Isotretinoin

Grants and funding

R01 HS0189960/HS/AHRQ HHS/United States