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21-229 Jan, 2000 , May, 2000 - fda

21-229 Jan, 2000 , May, 2000 - fda-2025

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The document provides a safety update on the post-marketing experience of omeprazole magnesium (Ome-Mg) MUPS tablets, focusing on adverse events reported globally since its launch in 1998. It details the history of omeprazole's use, its formulations, and the results of safety evaluations, including serious and non-serious adverse events. The report highlights two fatal cases linked to elderly patients with multiple health issues and discusses various non-fatal serious adverse events. Overall, it concludes that while omeprazole is generally safe, there are rare but serious risks associated with its use, particularly when marketed over-the-counter.

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