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FDA warning label updates have progressively acknowledged these additional serious complications: Gallbladder disease (March 2022): Increased risk of cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation) requiring surgical removal, with many patients developing symptoms severe enough to necessitate emergency cholecystectomy procedures Intestinal obstruction and ileus (September 2023): FDA acknowledged reports of intestinal blockages that halt normal bowel movement, potentially leading to bowel perforation, sepsis, and death without emergency intervention Pulmonary aspiration during anesthesia (November 2024): Recognition that delayed gastric emptying causes patients to retain food in stomachs far longer than expected, creating aspiration risks when undergoing procedures requiring sedation or general anesthesia Severe gastrointestinal adverse reactions (January 2025): FDA added warnings about serious GI events including severe gastroparesis symptoms and complications requiring hospitalization or surgical intervention The fact that patients who began treatment in 2017, 2018, or 2019 received medications without warnings about ileus, pulmonary aspiration, or severe gastroparesis demonstrates the alleged failure to provide timely and adequate disclosures about serious complications that medical science now clearly links to these medications

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For researchers who choose to continue treatment beyond one year, the trajectory is generally stable