{ "query": "lubiprostone", "ingredient": "lubiprostone", "slug": "lubiprostone", "rxcui": "623033", "brands": [ "Amitiza" ], "names": [ "lubiprostone" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 25 }, "boxed_warning": "", "indications_and_usage": "Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.2 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women \u2265 18 years old. ( 1.3 ) 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of lubiprostone in the treatment of op...", "contraindications": "Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5) ] . Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 , 5.5 )", "warnings_and_cautions": "Nausea : Patients may experience nausea; concomitant administration of food may reduce this symptom. ( 2.2 , 5.1 ) Diarrhea : Avoid use in patients with severe diarrhea. Instruct patients to discontinue lubiprostone and contact their healthcare provider if severe diarrhea occurs during treatment. ( 5.2 ) Syncope and Hypotension : May occur after taking the first dose or with subsequent doses. Generally resolves prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue lubiprostone and contact their healthcare provider if symptoms occur. ( 5.3 ) Dyspnea : May occur within an hour of first dose. Generally resolves within 3 hours, but may recur with repeat dosing. Instruct patients to contact their healthcare provider if symptoms occur. ( 5.4 ) Bowel Obstruction : Evaluate patients with symptoms suggestive of mechanical gastrointestinal obstruction prior to initiating treatment with lubiprostone. ( 4 , 5.5 ) 5.1 Nausea Patients taking lubiprostone may experience nausea. Concomitant administration of food with lubiprostone may reduce symptoms of nausea [ see Adverse Reactions (6.1) ] . 5.2 Diarrhea Avoid use of lubiprostone in patients with severe diarr...", "warnings": "", "adverse_reactions": "The following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Syncope and Hypotension [see Warnings and Precautions (5.3) ] Dyspnea [see Warnings and Precautions (5.4) ] Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence. ( 6.1 ) OIC: nausea and diarrhea. ( 6.1 ) IBS-C: nausea, diarrhea, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical development of lubiprostone for CIC, OIC, and IBS-C, 1648 patients were treated with lubiprostone for 6 months and 710 patients were treated for 1 year (not mutually exclusive). Chronic Idiopathic Constipation Adverse reactions in adult ...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Administration Instructions Instruct patients to take lubiprostone orally with food and water to reduce the occurrence of nausea [see Warnings and Precautions (5.1) ] . Swallow capsules whole and do not break apart or chew. Physicians and patients should periodically assess the need for continued therapy. Diarrhea Inform patients that they may experience diarrhea during treatment with lubiprostone. Instruct patients to discontinue lubiprostone and contact their healthcare provider if severe diarrhea occurs [see Warnings and Precautions (5.2) ]. Syncope and Hypotension Inform patients that they may experience syncope and hypotension after taking the first dose or subsequent doses of lubiprostone. Syncope and hypotension generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue lubiprostone and to contact their healthcare provider if these reactions occur [see Warnings and Precautions (5.3) ] . Inform patients that other adverse reactions may increase the risk of syncope and hypotension, such as diarrhea or vomiting. Dyspnea Inform patients that they may experience dyspnea within an hour of the first dose. Dyspnea generally resolves ...", "spl_medguide": "", "clinical_studies": "14.1 Chronic Idiopathic Constipation in Adults Two double-blinded, placebo-controlled studies of identical design were conducted in patients with CIC. CIC was defined as, on average, less than 3 SBMs per week (a SBM is a bowel movement occurring in the absence of laxative use) along with one or more of the following symptoms of constipation for at least 6 months prior to randomization: 1) very hard stools for at least a quarter of all bowel movements; 2) sensation of incomplete evacuation following at least a quarter of all bowel movements; and 3) straining with defecation at least a quarter of the time. Following a 2-week baseline/washout period, a total of 479 patients (mean age 47 [range 20 to 81] years; 89% female; 81% Caucasian, 10% African American, 7% Hispanic, 2% Asian, 11% at least 65 years of age) were randomized and received lubiprostone 24 mcg twice daily or placebo twice daily for 4 weeks. The primary endpoint of the studies was SBM frequency. The studies demonstrated that patients treated with lubiprostone had a higher frequency of SBMs during Week 1 than the placebo patients. In both studies, results similar to those in Week 1 were also observed in Weeks 2, 3, and 4 ...", "brand_name": "Lubiprostone", "manufacturer": "Dr. Reddy's Laboratories Inc.", "application_number": "NDA021908", "pharm_class_epc": [ "Chloride Channel Activator [EPC]" ], "route": [ "ORAL" ], "effective_time": "20260710", "set_id": "006b8b6c-f0eb-4246-87da-67582984b0e4", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 7818, "serious": 5390, "death": 882, "hospitalization": 2641, "primary_suspect": 7808, "top_reactions": [ [ "Nausea", 562 ], [ "Diarrhoea", 502 ], [ "Constipation", 458 ], [ "Drug Ineffective", 450 ], [ "Fatigue", 430 ], [ "Headache", 375 ], [ "Pain", 369 ], [ "Dizziness", 344 ], [ "Fall", 344 ], [ "Chronic Kidney Disease", 334 ], [ "Off Label Use", 320 ], [ "Vomiting", 307 ], [ "Dyspnoea", 287 ], [ "Malaise", 267 ], [ "Pyrexia", 255 ] ], "by_year": { "2019": 883, "2020": 735, "2021": 591, "2022": 435, "2023": 439, "2024": 442, "2025": 475, "2026": 264 }, "by_year_primary": { "2019": 882, "2020": 735, "2021": 589, "2022": 433, "2023": 438, "2024": 438, "2025": 475, "2026": 264 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20190513", "reason": "Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, th", "firm": "MALLINCKRODT PHARMACEUTICALS", "status": "Terminated" }, { "class": "Class II", "date": "20190513", "reason": "Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, th", "firm": "MALLINCKRODT PHARMACEUTICALS", "status": "Terminated" }, { "class": "Class III", "date": "20181106", "reason": "Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.", "firm": "Takeda Development Center Americas, Inc.", "status": "Terminated" } ], "recall_total": 3, "drugsfda": { "applications": 8, "nda": 1, "anda": 7, "first_approval": "20060131", "rems": false, "rems_last": "", "labeling_supplements": 6, "labeling_recent": 0, "sponsors": [ "AMNEAL", "ASCENT PHARMS INC", "DR REDDYS", "HUMANWELL PURACAP", "PH HEALTH", "SUCAMPO PHARMA LLC", "TEVA PHARMS USA INC", "ZYDUS PHARMS" ], "unapproved": false, "first_approval_fmt": "01/31/2006" }, "trials": { "total": 56, "completed": 43, "terminated": 7, "with_results": 39, "industry": 40, "phase3": 24, "results_share": 0.9069767441860465, "terminated_share": 0.125 }, "pubmed": { "rct": 36, "meta": 8, "recent_rct": 10, "cochrane": [] }, "payments": { "year": "2024", "usd": 192.91, "records": 7, "by_name": [ [ "Amitiza", 192.91 ] ], "names_checked": [ "lubiprostone", "Amitiza" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 446905, "beneficiaries": 123398, "spend": 59049847.019999996, "by_brand": [ { "brand": "Lubiprostone", "claims": 440018, "per_claim": 127.58537073, "is_generic": true }, { "brand": "Amitiza", "claims": 6887, "per_claim": 422.53337593, "is_generic": false } ], "per_claim": 132.13064749779033 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 1177, "fills": 446905, "per_million": 2633.669348071738, "ratio": 0.9511437845582008, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "2,634 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site", "Death share in reports is near or below the FAERS average (1.2x)" ], "weight": 0.35 }, "evidence": { "score": 47, "letter": "F", "why": [ "36 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 93, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III (-7)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $193 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "Generic versions approved (7 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 83, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are nausea, diarrhoea, constipation. How would we recognize and handle those?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }