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Tag Archives: FDA authorization

Almost one in three medications found to have safety concerns after FDA authorization

Almost one in three medications found to have safety concerns after FDA authorization

How regularly are safety concerns raised about a medication after it’s been endorsed by the FDA? Nicholas Downing, MD, of the Department of Medicine at Brigham and Women’s Hospital, and partners have found that for medications affirmed in the vicinity of 2001 and 2010, almost 1 in 3 had a post market safety occasion. The group characterizes post market wellbeing occasions as those that prompt either withdrawal from the market because of safety concerns, a boxed cautioning or FDA issuance of a safety correspondence. They found that of 222 novel therapeutics the FDA affirmed amid this day and age, three were pulled back, 61 gotten boxed notices and 59 evoked safety interchanges. The group’s discoveries are distributed in JAMA. The …

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