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These restrictions and warnings demonstrate the FDAs stringent consideration of patient safety in the drug approval process.108 In March 2015, the FDA required a black box warning on Tanzeum due to the observed risk of thyroid C-cell tumors in animals, although it is unclear if this effect also occurs in humans.108 Later, the FDA added a warning about the risk of anaphylactic shock to the medications label

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But the jump from 10mg to 15mg is much smaller: 21.4% to 22.5%

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HI related brain injury in human neonates result in a decrease in cerebral blood flow rate and an increase in BBB permeability (Volpe et al., 1985)

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