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A key difference between prescription and over-the-counter digestive enzymes is that the US Food and Drug Administration regulates the former as drugs, “so they undergo a rigorous approval ...
Common side effects include vomiting, abdominal pain, constipation, and diarrhea. [3] Other side effects include perianal irritation and high blood uric acid. [5] The enzymes are from pigs. [5] Use is believed to be safe during pregnancy. [5] The components are digestive enzymes similar to those normally produced by the human pancreas. [6]
Serious side effects may include bezoar formation and encephalopathy. [6] Use appears to be safe in pregnancy and breastfeeding. [6] How it works is unclear but is believed to involve binding to the ulcer and protecting it from further damage. [3] [6] Sucralfate was approved for medical use in the United States in 1981. [3]
Orlistat has a few adverse effects. Most reported side effects are gastrointestinal; including liquid stools, steatorrhea and abdominal pain. More severe and serious are interactions between orlistat and anticoagulants when given in combination. It can increase INR which can lead to insufficient anticoagulant treatment and bleeding. [12]
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On 23 January 2006, an FDA advisory panel voted 11 to 3 to recommend the approval of an OTC formulation of orlistat, to be sold under the brand name Alli by GlaxoSmithKline. [41] Approval was granted on 7 February 2007, [42] and Alli became the first weight loss drug officially sanctioned by the U.S. government for over-the-counter use. [43]
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