The International journal of risk & safety in medicine
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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. ⋯ 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.