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Complete aperistalsis of esophagus/upper esophageal sphincter pressure was excessively high [oesophageal motility disorder].Dysphagia/trouble swallowing food and water [dysphagia].Capsule got lodged in her throat [foreign body in throat].Felt like being choked [choking].Numbness of face and hands [hypoaesthesia].Feeling anxious and stressed [anxiety].Increased heart rate [tachycardia].Chest pain [chest pain].Acid reflux [gastrooesophageal reflux disease].Losing weight of 30 lbs [weight decreased].Mild irritation and everything looked perfectly normal with no strictures or lesions [oesophageal irritation].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on (b)(6) 2020, and follow-up information was received on 12-apr-2021 and 19-apr-2021.A (b)(6) year-old female patient (weight (b)(6) lbs) experienced dysphagia and numbness of face and hands, capsule lodged in throat, anxiety and stress, felt like choked, chest pain, increased heart rate, acid reflux, esophageal motility disorder, esophageal irritation and weight loss while on plenity for weight management.The patient had no past medical history and concomitant medications were not reported.The patient had no known drug allergies.On (b)(6) 2020, the patient started therapy with plenity at a dose of three capsules by mouth with 16 ounces (2 glasses) of water 20-30 minutes before lunch and dinner for weight management.The lot number and expiry date were not reported.It was reported that the patient did not follow an exercise regimen or a diet plan.On (b)(6) 2020, the patient took 3 capsules before dinner and it got stuck in her throat (pt: foreign body in throat).The patient tried to wash down with fluids but nothing worked out and attempted to induce vomiting without success.The patient continuously felt like hands and face kept going numb which lasted for 2 hours (pt: hypoaesthesia).The patient went to bed and had severe chest pain (pt: chest pain) which slept off with a heating pad.It was reported that the patient did not go to the hospital due to covid at hospital.The patient was unable to tolerate any ounce of food or liquids and felt difficult even to swallow or spit but never had difficulty breathing.On the same day, the patient felt anxious and stressed (pt: anxiety) as she felt like being choked (pt: choking).The patient also started experiencing increased heart rate (pt: tachycardia) due to anxiety and stress.On the same day, the patient recovered from event numbness of face and hands.On unspecified date in 2020, the patient experienced difficulty and was unable to swallow food and water (pt: dysphagia).On (b)(6) 2020, the patient went to ent (otolaryngology) where she had an endoscopy and could not see that pills were still lodged.On (b)(6) 2020, the patient still unable to tolerate the food and liquids.The patient underwent another endoscopy which showed: mild irritation and everything looked perfectly normal with no strictures or lesions (pt: oesophageal irritation).The patient also tried very hard to get ensure and yogurt down all of which made the patient felt as though it was clamped shut.Another endoscopy was performed and reported they had never seen a product expanded in a patient¿s throat like plenity had done.On an unknown date, the patient also developed acid reflux (pt: gastrooesophageal reflux disease) and prescribed with omeprazole (40 mg, once daily).The patient reported that she did not experience acid reflux before.On an unknown date, the patient was prescribed with ativan (lorazepam) 0.5 mg, twice daily, as needed for anxiety that was developed due to the trauma.On (b)(6) 2020, the patient went to hospital to receive iv fluids as she was unable to swallow water and food.The patient underwent a manometry which showed: complete aperistalsis of esophagus and failed 10/10 swallows and upper esophageal sphincter pressure was excessively high.Various specialists and tests determined that the patient¿s swallowing mechanism was fine but oesophageal muscles were not contracting appropriately (pt: oesophageal motility disorder) due to damage caused by plenity.On an unspecified date, the patient's upper pressure in esophagus was reported as 185.On (b)(6) 2020, the patient reported losing weight of 30 lbs and was bedridden (pt: weight decreased).The doctors performed a barium swallow which showed: slowing of transit of the liquid barium and some barium was hanged in the upper esophagus which they had to water down and was unable to tolerate consistency.On (b)(6) 2021, the patient underwent esophageal dilation and achalasia ruled out, which helped to tolerate liquid and smoothies again.On (b)(6) 2021, the patient underwent swallow test (focused only on her throat) which showed: normal results and no aspiration.On (b)(6) 2021, the patient underwent barium swallow which showed: peristalsis returned and confirmed the pill impaction caused paralysis of esophageal muscles which took almost 4 months to heal.On (b)(6) 2021, the patient reported that he could eat properly.The physician stated that obstruction of pills caused the dysmotility and had no gi issues prior to the event and the patient also underwent blood tests to rule out any rheumatory diseases.It was reported that the patient took iv fluids to support hydration but did not confirm whether this treatment was continued.The patient reported that the events were debilitating and scary.The patient reported that she was better and was able to eat and drink again but reported that everything she eats must be moist and carefully chewed before swallowing.At the time of this report, therapy status with plenity was withdrawn.The outcome of the event numbness of face and hands was resolved and with events dysphagia, capsule lodged in throat, anxiety and stress, chest pain, increased heart rate, acid reflux, esophageal irritation and weight loss were not resolved, with event esophageal motility disorder was resolving and with event choke on medication was resolved with sequelae.This case was verified by a healthcare professional.A pharmaceutical product complaint had been registered with this report.Follow-up information received on 12-apr-2021, and 19-apr-2021, included: patient demographics details were updated, plenity indication was updated to weight management (previously not reported), treatment medications were updated, start date and stop date of plenity were reported (previously not reported), outcome of the event dysphagia was updated to not resolved (previously reported as resolved), additional events anxiety, choke on medication, medication stuck in throat, chest pain, increased heart rate, acid reflux, esophageal motility disorder and weight loss were added.Endoscopy results were updated, patient initials updated, start date of event weight loss was updated to (b)(6) 2020, and start date of event esophageal motility disorder was updated to (b)(6) 2020, additional event esophageal irritation was added, outcome of the event esophageal motility disorder was updated to resolving (previously reported as not resolved), choke on medication was updated to resolved with sequelae (previously reported as not resolved).Narrative updated.Company comment: this spontaneous report by a physician refers to a (b)(6) year-old female patient weighing (b)(6) lbs who complained of "medication stuck in throat" after taking plenity on day 7.She also reported that the capsules expanded in her upper esophagus feeling choked (pt - choking), and her hands and face went numb for two hours (pt: numbness).She also experienced anxiety, chest pain, increased heart rate, dysphagia for several days (ongoing) resulting in weight loss and acid reflux.Endoscopy performed few days later did not reveal pills lodged in the esophagus but showed mild esophageal irritation (pt: esophageal irritation).Persistent dysphagia prompted her to undergo further evaluation with manometry and barium swallow which revealed complete absence of peristalsis in the esophagus along with elevated upper esophageal sphincter pressure (pt: esophageal motility disorder), and slowing of transit of the liquid barium and some barium hanging in the upper esophagus all of which were attributed by her treating physicians to the damage caused by lodging of pills considering the sudden onset of the dysphagia and ruling out other causes of motility disorders - achalasia, rheumatoid disorder.She underwent esophageal dilatation following which she was able to tolerate liquid foods and smoothies.Most recent endoscopy ((b)(6) 2021) confirmed return of peristalsis, though the patient still complained of dysphagia.She also received iv fluids to maintain hydration on multiple occasions.Patient did not have any significant past medical history and no concomitant medications were reported.Patient no longer takes plenity.The case was assessed as serious as patient experienced prolonged dysphagia (impairment of esophageal function) resulting in significant weight loss and also required multiple medical interventions (hospital visits, endoscopies, manometry, esophageal dilatation, iv fluids) to support her hydration.Causality of the events were assessed as possibly related due to plausible temporal relationship.
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