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Gerd triggered by the plenity/ reflux/nausea/ enlarged tonsil from vomiting/ gastritis [gastrooesophageal reflux disease].H.Pylori infection [helicobacter infection].Type 1 diabetes [type 1 diabetes mellitus].Diabetic ketoacidosis [diabetic ketoacidosis].Enlarged tonsil from vomiting [tonsillar hypertrophy].Case narrative: this initial spontaneous report was received from the united states of america reported by ro physician on (b)(6) 2021 and (b)(6) 2021.A (b)(6) female patient (weight (b)(6) height 167.6 cm) reported nausea, vomiting, gastritis, enlarged tonsils, gastrooesophageal reflux disease, gastric infection, diabetes mellitus, and diabetic ketoacidosis while on plenity for weight management.The patient¿s body mass index (bmi) was 29.9 and had history of childhood asthma.She had previous gestational diabetes diagnosed when pregnant and gave birth in (b)(6) 2020.She had past episodes of gastrooesophageal reflux disease (gerd) but had mild reflux or occasional heartburn when she had acidic foods and it was bad during pregnancy.Since giving birth in the month of may, she did not had an episode but prior to getting pregnant, she would wake up with hoarseness after heartburn maybe 2-3 times a year.She received treatment with pepcid for heartburn which made her to feel better, but not treated daily for gerd and she¿denied breastfeeding.At (b)(6) years, she had a liposuction however, there were no contraindications noted.She had no past episodes of diabetic ketoacidosis (dka).She had no other surgeries, infections or stress and no family history of type 1 diabetes milletus.The patient was not on any other concomitant medications and medical devices.On (b)(6) 2021, the patient started therapy with plenity (0.75 gms) 3 pills with lunch and 3 pills with dinner with 24oz of water for weight management.Lot number and expiry date were not available.The patient confirmed that she had used plenity as per recommendation of use in conjunction with diet and exercise.On an unknown date in around first or second week of feb-2021, the patient stopped taking plenity due to reflux.On (b)(6) 2021 (3 weeks of starting therapy with plenity), she experienced nausea and reflux which led to vomiting and gastritis as determined by hospital endoscopy which then triggered dka.She reported that the symptoms were severe.From (b)(6) 2021, the patient was hospitalized in the intensive care unit due to gerd (pt: gastrooesophageal reflux disease) triggered by plenity.It was reported that gerd led to a severe stomach infection diagnosed as helicobacter pylori infection (pt: helicobacter pylori infection) which caused a rapid onset of type 1 diabetes (pt: type 1 diabetes mellitus) following a diabetic ketoacidosis episode (pt: diabetic ketoacidosis).Endoscopy was done in hospital which determined helicobacter pylori infection, gerd and enlarged tonsil (pt: tonsillar hypertrophy) from vomiting.Lab tests determined type 1 diabetes (blood glucose: 404 (units unspecified)).Urine test determined dka.The patient took antibiotics (unspecified) for stomach infection and gerd, insulin for type 1 diabetes as treatment.The other treatment medications were potassium intravenous (iv) drip and pepto bismol (bismuth subsalicylate).It was reported that the patient diagnosed with type 1 diabetes and dka for the first time after starting plenity.Action taken: the patient discontinued plenity therapy due to the events.At the time of this report, the outcome of the events gastrooesophageal reflux disease, helicobacter pylori infection, diabetic ketoacidosis, enlarged tonsils was reported as resolved and the outcome of the event diabetes mellitus was reported as not resolved.The case was assessed as serious due to hospitalization.This case was verified by a healthcare professional.Company comment: a (b)(6) female patient with medical history significant for childhood asthma, gestational diabetes and gerd aggravated during pregnancy, experienced nausea, vomiting, tonsillar hypertrophy, gastroesophageal reflux disease, h.Pylori infection, diabetic ketoacidosis and type 1 diabetes mellitus while on therapy with plenity.As per the patient, gerd may have led to the development of h.Pylori infection, triggering an episode of diabetic ketoacidosis (dka) following which she was diagnosed to have rapid onset type 1 diabetes mellitus.Patient was not taking any other concomitant medications.Patient is no longer taking plenity and completely recovered from all the events following supportive therapy and is currently on insulin for type 1 diabetes mellitus.The case was assessed as serious as the events resulted in hospitalization and required icu support.Considering the reasonable temporal relationship and known safety profile, nausea, vomiting and gerd were assessed as possibly related to plenity.The role of plenity in contributing to tonsillar hypertrophy due to vomiting, h.Pylori infection due to gerd, further triggering initial episode of dka could not be ruled out based on the current available information.Type 1 diabetes mellitus was considered unlikely related to plenity based on its non-systemic nature of action (confined only to gastrointestinal tract).However, childhood asthma and gestational diabetes could have predisposed her to type 1 diabetes.Also her previous episodes of reflux along with her recent worsening of gerd during her pregnancy could have contributed to the development of h.Pylori infection.Emotional stress due to her recent child birth may also have triggered an episode of dka.As per ro physician's assessment, plenity could have increased patient's gerd but did not cause or contribute to the stomach infection, type 1 diabetes onset, or dka; rather her medical history, gestational diabetes and per oral medications could have resulted in these events.
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