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Slowed gastric motility at 15 mg can lead to constipation, particularly if fluid and fiber intake are inadequate

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The Warning Letter states that serious and unexpected ADEs remained in medical review status beyond the period allowed by procedure, and that this delay prevented timely submission to FDA

Referencias Emma Simonsen MD , Lars Christian Lund PhD , Martin Thomsen Ernst MSc , Vidar Hjellvik PhD , Laszlo Hegeds DMSc , Steffen Hamann PhD , ystein Kalsnes Jrstad PhD , et al