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Warnings and Precautions 5.1 Serious Infections Patients treated with HUMIRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death

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While the risk of initiating TNF- inhibitors (adjusted IRR: 0.56, 95% CI: 0.321.00) and IBD-related surgery (adjusted IRR: 0.79, 95% CI: 0.571.09) was also reduced, these associations were not statistically significant

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The FDA has issued guidance that compounders should wind down production within a defined transition period after a shortage is resolved, though the exact enforcement approach has been subject to legal challenges