Affiliations: [a] International Center for Pharmaceutical Economics and Policy, MCPHS University, Boston, MA, USA
| [b]
Brigham and Women’s Hospital, Division of General Medicine and Primary Care, Boston, MA, USA
| [c] School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA
Correspondence:
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Address for correspondence: Rosa Rodriguez-Monguio, Ph.D., M.S., Associate Professor, Health Policy and Management, University of Massachusetts, Amherst, School of Public Health and Health Sciences, 715 N. Pleasant Street, 322 Arnold House, Amherst, MA 01003, USA. Tel.: +1 413 545 7427; Fax: +1 413 545 1645; E-mail: [email protected].
Abstract: OBJECTIVES: Concerns about safety and complexity of diabetes treatments have increased overtime. We assessed secular trends in the FDA approvals, market discontinuations, and safety actions of all antidiabetic drugs marketed in the US in the period 1980–2015. METHODS: Regulatory and safety related information about FDA-approved pharmaceuticals for diabetes treatment was collected from the FDA databases, the Orange Book, and Drugs@FDA. Descriptive statistics were performed to describe trends in approvals, discontinuations, and safety actions. RESULTS: The number of insulins and analogue approvals declined after the 1980s; whereas, the approvals of non-insulin antidiabetic drugs increased after 1995. The number of antidiabetic drugs with FDA safety actions significantly increased overtime. Overall, 59.0% of insulins and analogues and 5.7% of non-insulin antidiabetic drugs were discontinued from the market. The FDA released at least one safety action for 7.7% of insulins and analogues and 88.7% of non-insulin antidiabetic drugs. CONCLUSION: Newly approved antidiabetic drugs have raised safety concerns and led to FDA safety regulatory actions including boxed warnings, risk evaluation and mitigation strategies, medication guides, and safety communications to health care providers. There is a need for systematic post-marketing studies assessing the long-term safety of antidiabetic drugs to improve patient safety and health outcomes.
Keywords: FDA, drug safety, drug approvals, market discontinuations, antidiabetic drugs
