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BMJ Open Gastroenterol
In the same FDA drug safety communication, post-marketing cases of urosepsis and pyelonephritis were discussed, leading to the addition of warnings of severe infections to the prescribing information for these products
Risks that remain real even if the drug does not transfer Drug transfer into milk is only one piece of the puzzle
The established adverse effect profile, based on clinical trial data submitted to regulatory authorities such as the MHRA and EMA, predominantly features gastrointestinal symptoms
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