|
MERCK SHARP & DOHME CORP. WILSON NASONEX NASAL SPRAY INHALER (DEVICE); NASAL SPRAY, ENT DELIVERY (KCO)
|
Back to Search Results |
|
| Device Problem
Patient-Device Incompatibility (2682)
|
| Patient Problems
Asthma (1726); Dyspnea (1816); Ecchymosis (1818); Hyperemia (1904); Hypersensitivity/Allergic reaction (1907); Neuropathy (1983); Sleep Dysfunction (2517); Wheezing (4463)
|
|
Event Type
malfunction
|
|
Event Description
|
|
Asthma [asthma].Blood count abnormal [full blood count abnormal].Bronchial wall thickening [bronchial wall thickening].Bronchopulmonary aspergillosis [bronchopulmonary aspergillosis].Chest discomfort [chest discomfort].Dyspnoea [dyspnoea].Ecchymosis [ecchymosis].Loss of personal independence in daily activities [loss of personal independence in daily activities].Lung disorder [lung disorder].Nasal polyps [nasal polyps].Neuropathy peripheral [neuropathy peripheral].Ocular hyperaemia [ocular hyperaemia].Pain in extremity [pain in extremity].Paraesthesia [paraesthesia].Sleep disorder due to a general medical condition [sleep disorder due to a general medical condition].Therapeutic product effect incomplete [therapeutic product effect incomplete] wheezing [wheezing].Drug hypersensitivity [drug hypersensitivity].Case narrative: information has been received from bayer (ca-bayer-2021-044960) on 20-jan-2023.This case was initially received by license partner: 009507513 (reference number: (b)(4) on 25-jan-2021.The most recent information was received on 16-jan-2023 and was forwarded to bayer on 16-jan-2023.The license partner had received the report from a regulatory authority (reference number: (b)(4).This female patient was involved in an organized data collection program.The patient received mometasone furoate (nasonex) for an unknown indication.The case describes the occurrence of asthma ('asthma'), full blood count abnormal ('blood count abnormal'), bronchial wall thickening ('bronchial wall thickening'), bronchopulmonary aspergillosis ('bronchopulmonary aspergillosis'), chest discomfort ('chest discomfort'), dyspnoea ('dyspnoea'), ecchymosis ('ecchymosis'), loss of personal independence in daily activities ('loss of personal independence in daily activities'), lung disorder ('lung disorder'), nasal polyps ('nasal polyps'), neuropathy peripheral ('neuropathy peripheral'), ocular hyperaemia ('ocular hyperaemia'), pain in extremity ('pain in extremity'), paraesthesia ('paraesthesia'), sleep disorder due to a general medical condition ('sleep disorder due to a general medical condition'), wheezing ('wheezing') and drug hypersensitivity ('drug hypersensitivity').Co-suspect products included albuterol sulfate, prednisone, fluticasone furoate (+) vilanterol trifenatate (breo ellipta) and mepolizumab (nucala) for asthma, montelukast sodium (singulair), ciclesonide (alvesco), glycopyrrolate (glycopyrronium bromide), levofloxacin, montelukast sodium (manufacturer unknown), acetylsalicylic acid and budesonide (+) formoterol fumarate for an unknown indication, salbutamol sulfate, glycopyrronium bromide, budesonide (pulmicort), mometasone furoate (nasonex allergy) and dexamethasone.Other product or product use issues identified: therapeutic product effect incomplete ¿(therapeutic product effect incomplete)" (seriousness criteria hospitalization and medically significant).The patient's concurrent conditions included asthma and product used for unknown indication.On an unknown date, the patient started mometasone furoate (nasonex) (nasal) at an unspecified dose and frequency.Further treatment at an unspecified dose and frequency was started on an unknown date.On an unknown date, the patient started montelukast sodium (manufacturer unknown) (oral), 10 milligram (mg) daily.On an unknown date, the patient started glycopyrrolate (unknown), 1 dosage form(s) daily.On an unknown date, the patient started mometasone furoate (nasonex allergy) at an unspecified dose and frequency.On an unknown date, the patient started mepolizumab (nucala) (intravenous) 100 mg at an unspecified frequency.On an unknown date, the patient started salbutamol sulfate at an unspecified dose and frequency.On an unknown date, the patient started montelukast sodium (singulair) (oral), 10 mg daily.On an unknown date, the patient started budesonide (pulmicort) at an unspecified dose and frequency.On an unknown date, the patient started prednisone (unknown) at an unspecified dose and frequency.On an unknown date, the patient started ciclesonide (alvesco), 2 dosage form(s) twice per day.On an unknown date, the patient started fluticasone furoate (+) vilanterol trifenatate (breo ellipta) (unknown), 1 dosage form (s) daily.On an unknown date, the patient started glycopyrronium bromide at an unspecified dose and frequency.On an unknown date, the patient started acetylsalicylic acid at an unspecified dose and frequency.On an unknown date, the patient started budesonide (+) formoterol fumarate at an unspecified dose and frequency.On an unknown date, the patient started levofloxacin (unknown) at an unspecified dose and frequency.On an unknown date, the patient started dexamethasone at an unspecified dose and frequency.On an unknown date, the patient started albuterol sulfate (unknown) 2 dosage form(s) at an unspecified frequency.On an unknown date, the patient experienced asthma (seriousness criteria hospitalization and medically significant), bronchial wall thickening seriousness criteria hospitalization and medically significant), bronchopulmonary aspergillosis (seriousness criteria hospitalization and medically significant), chest discomfort (seriousness criteria hospitalization and medically significant), dyspnoea (seriousness criteria hospitalization and medically significant), ecchymosis (seriousness criteria hospitalization and medically significant), loss of personal independence in daily activities (seriousness criteria hospitalization and medically significant), lung disorder (seriousness criteria hospitalization and medically significant), nasal polyps (seriousness criteria hospitalization and medically significant), neuropathy peripheral (seriousness criteria hospitalization and medically significant), ocular hyperaemia (seriousness criteria hospitalization and medically significant), pain in extremity (seriousness criteria hospitalization and medically significant), paraesthesia (seriousness criteria hospitalization and medically significant), sleep disorder due to a general medical condition (seriousness criteria hospitalization and medically significant), wheezing (seriousness criteria hospitalization and medically significant) and drug hypersensitivity (seriousness criteria hospitalization and medically significant) and was found to have full blood count abnormal (seriousness criteria hospitalization and medically significant).It was unknown whether any action was taken with mometasone furoate (nasonex).It was unknown whether any action was taken with montelukast sodium (singulair).It was unknown whether any action was taken with albuterol sulfate.It was unknown whether any action was taken with prednisone.It was unknown whether any action was taken with ciclesonide (alvesco).It was unknown whether any action was taken with fluticasone furoate (+) vilanterol trifenatate (breo ellipta).It was unknown whether any action was taken with glycopyrrolate.It was unknown whether any action was taken with levofloxacin.At the time of the report, the asthma, full blood count abnormal, bronchial wall thickening, bronchopulmonary aspergillosis, chest discomfort, dyspnoea, ecchymosis, loss of personal independence in daily activities, lung disorder, nasal polyps, neuropathy peripheral, ocular hyperaemia, pain in extremity, paraesthesia, sleep disorder due to a general medical condition, wheezing and drug hypersensitivity had resolved.The reporter considered asthma, bronchial wall thickening, bronchopulmonary aspergillosis, chest discomfort, drug hypersensitivity, dyspnoea, ecchymosis, full blood count abnormal, loss of personal independence in daily activities, lung disorder, nasal polyps, neuropathy peripheral, ocular hyperaemia, pain in extremity, paraesthesia, sleep disorder due to a general medical condition and wheezing to be related to mometasone furoate (nasonex).Most recent follow-up information incorporated above includes: on 16-jan-2023: new suspect- salbutamol sulfate, glycopyrronium bromide, budesonide (pulmicort), mometasone furoate (nasonex allergy) and congestion (discrepancy), dexamethasone was added, event outcome change for event- drug hypersensitivity from unknown to recovered/resolved, seriousness criteria also added for same event, new regulatory authority reporter was added.Bayer causality assessment: mometasone furoate (nasonex).Asthma: not assessable.Bronchopulmonary aspergillosis: not assessable.Chest discomfort: not assessable.Drug hypersensitivity: not assessable.Dyspnoea: not assessable.Ecchymosis: not assessable.Lung disorder: not assessable.Nasal polyps: not assessable.Neuropathy peripheral: not assessable.Ocular hyperaemia: not assessable.Pain in extremity: not assessable.Paraesthesia: not assessable.Wheezing: not assessable.Sleep disorder due to a general medical condition: not assessable.Full blood count abnormal: not assessable.Bronchial wall thickening: not assessable.Loss of personal independence in daily activities: not assessable.Therapeutic product effect incomplete: not assessable.Case comments: based on the limited information currently available for this case, and in accordance with the who causality scale, the report is considered unassessable.A reasonable possibility to suggest a relationship between the medication singulair and nasonex therapy and the reported serious adverse events of asthma, full blood count abnormal, bronchial wall thickening, bronchopulmonary aspergillosis, chest discomfort, dyspnoea, ecchymosis, loss of personal independence in daily activities, lung disorder, nasal polyps, neuropathy peripheral, ocular hyperaemia, pan in extremity, paresthesia, sleep disorder due to a general medical condition, therapeutic product effect incomplete, wheezing, and drug hypersensitivity cannot be established.Additional information regarding the enrolled study, the subject's concurrent conditions, concomitant medications, medical history, dates and indication for singulair and nasonex and co-suspect medications administration, onset dates of the adverse events, date of hospitalization, diagnostic test results, symptoms of the event of therapeutic product effect incomplete, treatment, clinical course and outcome is essential to provide a causality assessment.
|
| |
|
Event Description
|
|
Asthma [asthma]; full blood count abnormal [full blood count abnormal]; bronchial wall thickening [bronchial wall thickening]; bronchopulmonary aspergillosis [bronchopulmonary aspergillosis]; chest discomfort [chest discomfort]; dyspnoea [dyspnoea]; ecchymosis [ecchymosis]; loss of personal independence in daily activities [loss of personal independence in daily activities]; lung disorder [lung disorder]; nasal polyps [nasal polyps]; neuropathy peripheral [neuropathy peripheral]; ocular hyperaemia [ocular hyperaemia]; pain in extremity [pain in extremity] paraesthesia [paraesthesia] sleep disorder due to a general medical condition [sleep disorder due to a general medical condition] therapeutic product effect incomplete [therapeutic product effect incomplete] wheezing [wheezing] drug hypersensitivity [drug hypersensitivity] case narrative: information has been received from bayer ((b)(4) on 20-jan-2023.This case was initially received by license partner (b)(6) (reference number: (b)(4)) on 25-jan-2021.The most recent information was received on 16-jan-2023 and was forwarded to bayer on 16-jan-2023.The license partner had received the report from a regulatory authority (reference number: (b)(4)).This female patient was involved in an organized data collection program.The patient received mometasone furoate (nasonex) for an unknown indication.The case describes the occurrence of asthma ('asthma'), full blood count abnormal ('blood count abnormal'), bronchial wall thickening ('bronchial wall thickening'), bronchopulmonary aspergillosis ('bronchopulmonary aspergillosis'), chest discomfort ('chest discomfort'), dyspnoea ('dyspnoea'), ecchymosis ('ecchymosis'), loss of personal independence in daily activities ('loss of personal independence in daily activities'), lung disorder ('lung disorder'), nasal polyps ('nasal polyps'), neuropathy peripheral ('neuropathy peripheral'), ocular hyperaemia ('ocular hyperaemia'), pain in extremity ('pain in extremity'), paraesthesia ('paraesthesia'), sleep disorder due to a general medical condition ('sleep disorder due to a general medical condition'), wheezing ('wheezing') and drug hypersensitivity ('drug hypersensitivity').Co-suspect products included albuterol sulfate, prednisone, fluticasone furoate (+) vilanterol trifenatate (breo ellipta) and mepolizumab (nucala) for asthma, montelukast sodium (singulair), ciclesonide (alvesco), glycopyrrolate (glycopyrronium bromide), levofloxacin, montelukast sodium (manufacturer unknown), acetylsalicylic acid and budesonide (+) formoterol fumarate for an unknown indication, salbutamol sulfate, glycopyrronium bromide, budesonide (pulmicort), mometasone furoate (nasonex allergy) and dexamethasone.Other product or product use issues identified: therapeutic product effect incomplete ¿(therapeutic product effect incomplete)" (seriousness criteria hospitalization and medically significant).The patient's concurrent conditions included asthma and product used for unknown indication.On an unknown date, the patient started mometasone furoate (nasonex) (nasal) at an unspecified dose and frequency.Further treatment at an unspecified dose and frequency was started on an unknown date.On an unknown date, the patient started montelukast sodium (manufacturer unknown) (oral), 10 milligram (mg) daily.On an unknown date, the patient started glycopyrrolate (unknown), 1 dosage form(s) daily.On an unknown date, the patient started mometasone furoate (nasonex allergy) at an unspecified dose and frequency.On an unknown date, the patient started mepolizumab (nucala) (intravenous) 100 mg at an unspecified frequency.On an unknown date, the patient started salbutamol sulfate at an unspecified dose and frequency.On an unknown date, the patient started montelukast sodium (singulair) (oral), 10 mg daily.On an unknown date, the patient started budesonide (pulmicort) at an unspecified dose and frequency.On an unknown date, the patient started prednisone (unknown) at an unspecified dose and frequency.On an unknown date, the patient started ciclesonide (alvesco), 2 dosage form(s) twice per day.On an unknown date, the patient started fluticasone furoate (+) vilanterol trifenatate (breo ellipta) (unknown), 1 dosage form (s) daily.On an unknown date, the patient started glycopyrronium bromide at an unspecified dose and frequency.On an unknown date, the patient started acetylsalicylic acid at an unspecified dose and frequency.On an unknown date, the patient started budesonide (+) formoterol fumarate at an unspecified dose and frequency.On an unknown date, the patient started levofloxacin (unknown) at an unspecified dose and frequency.On an unknown date, the patient started dexamethasone at an unspecified dose and frequency.On an unknown date, the patient started albuterol sulfate (unknown) 2 dosage form(s) at an unspecified frequency.On an unknown date, the patient experienced asthma (seriousness criteria hospitalization and medically significant), bronchial wall thickening seriousness criteria hospitalization and medically significant), bronchopulmonary aspergillosis (seriousness criteria hospitalization and medically significant), chest discomfort (seriousness criteria hospitalization and medically significant), dyspnoea (seriousness criteria hospitalization and medically significant), ecchymosis (seriousness criteria hospitalization and medically significant), loss of personal independence in daily activities (seriousness criteria hospitalization and medically significant), lung disorder (seriousness criteria hospitalization and medically significant), nasal polyps (seriousness criteria hospitalization and medically significant), neuropathy peripheral (seriousness criteria hospitalization and medically significant), ocular hyperaemia (seriousness criteria hospitalization and medically significant), pain in extremity (seriousness criteria hospitalization and medically significant), paraesthesia (seriousness criteria hospitalization and medically significant), sleep disorder due to a general medical condition (seriousness criteria hospitalization and medically significant), wheezing (seriousness criteria hospitalization and medically significant) and drug hypersensitivity (seriousness criteria hospitalization and medically significant) and was found to have full blood count abnormal (seriousness criteria hospitalization and medically significant).It was unknown whether any action was taken with mometasone furoate (nasonex).It was unknown whether any action was taken with montelukast sodium (singulair).It was unknown whether any action was taken with albuterol sulfate.It was unknown whether any action was taken with prednisone.It was unknown whether any action was taken with ciclesonide (alvesco).It was unknown whether any action was taken with fluticasone furoate (+) vilanterol trifenatate (breo ellipta).It was unknown whether any action was taken with glycopyrrolate.It was unknown whether any action was taken with levofloxacin.At the time of the report, the asthma, full blood count abnormal, bronchial wall thickening, bronchopulmonary aspergillosis, chest discomfort, dyspnoea, ecchymosis, loss of personal independence in daily activities, lung disorder, nasal polyps, neuropathy peripheral, ocular hyperaemia, pain in extremity, paraesthesia, sleep disorder due to a general medical condition, wheezing and drug hypersensitivity had resolved.The reporter considered asthma, bronchial wall thickening, bronchopulmonary aspergillosis, chest discomfort, drug hypersensitivity, dyspnoea, ecchymosis, full blood count abnormal, loss of personal independence in daily activities, lung disorder, nasal polyps, neuropathy peripheral, ocular hyperaemia, pain in extremity, paraesthesia, sleep disorder due to a general medical condition and wheezing to be related to mometasone furoate (nasonex).Most recent follow-up information incorporated above includes: on 16-jan-2023: new suspect- salbutamol sulfate, glycopyrronium bromide, budesonide (pulmicort), mometasone furoate (nasonex allergy) and congestion (discrepancy), dexamethasone was added, event outcome change for event- drug hypersensitivity from unknown to recovered/resolved, seriousness criteria also added for same event, new regulatory authority reporter was added.Bayer causality assessment: mometasone furoate (nasonex) asthma: not assessable bronchopulmonary aspergillosis: not assessable chest discomfort: not assessable drug hypersensitivity: not assessable dyspnoea: not assessable ecchymosis: not assessable lung disorder: not assessable nasal polyps: not assessable neuropathy peripheral: not assessable ocular hyperaemia: not assessable pain in extremity: not assessable paraesthesia: not assessable wheezing: not assessable sleep disorder due to a general medical condition: not assessable full blood count abnormal: not assessable bronchial wall thickening: not assessable loss of personal independence in daily activities: not assessable therapeutic product effect incomplete: not assessable follow up information has been received from health authority canada ((b)(4)) on 30-jan-2023.The concomitant drug mepolizumab (nucala) was added, at a dose of 100 mg via intravenous route (not otherwise specified) for asthma.The formulation of ciclesonide (alvesco) was reported as aerosol, metered.Additional regimen was added for fluticasone furoate (+) vilanterol trifenatate (breo ellipta) inhalation at a dose of 1 dosage form 2 every one day (strength, lot# and expiration date were not reported).Additional regimen added for glycopyrronium bromide at a dose of 1 dosage form 1 every 1 days for an unknown indication.Additional regimen for salbutamol was added at a dose of 2 dosage forms for asthma.Lower-level term (llt) of event full blood count was updated (previously reported as blood count abnormal).Follow-up information has been received from other health professional via health authority canada (agency # (b)(4)) on 16-may-2023.The dosage form of inhalation was added to regimen 1# of fluticasone furoate (+) vilanterol trifenatate (breo ellipta).A dosage regimen was added for salbutamol sulfate with dosage form: not specified via an unknown route for an unknown indication (lot#, expiration date, dose, frequency and strength were not provided).Indication of 'product used for unknown indication' was added for dexamethasone, mometasone furoate (nasonex allergy) and budesonide (pulmicort).Follow-up information has been received from other health professional via health authority canada (agency # (b)(4)) on 25-sep-2023.The report type was updated as spontaneous.The suspect levofloxacin was updated to levofloxacin hemihydrate.On an unknown date, the patient started mometasone furoate (manufacturer unknown) via unknown route (dose, frequency not reported) for unknown indication.Additional dosage regimens were added for suspect therapies: ciclesonide (alvesco) had 2 regimens added, 1st with 2 dosage form (df) 1 every 12 hours (q12h) (df aerosol for inhalation) and 2nd with 2 df, 1 every 1 days (qd) with dr: aerosol for inhalation, both via unknown route for unknown indication; fluticasone furoate (+) vilanterol trifenatate (breo ellipta) inhalation with 2 regimens, 1st with 1 df, 1 every 12 hours (q12h) via unknown route, and 2nd with 1 df, 1 every 12 hours (q12h) via inhalation use; budesonide (+) formoterol fumarate (df not specified) 2 df (qd) via unknown route; glycopyrronium bromide with 1 df, q12h via unknown route; prednisone via unknown route (dose, frequency not reported); budesonide (pulmicort) (df not specified) with 1df, q12h via unknown route; salbutamol sulfate with 2 regimens, 1st with 2 df (df not specified) via unknown route, and 2nd with 100 micrograms via unknown route (frequency not reported) for asthma; levofloxacin hemihydrate (df not specified) via unknown route (dose, frequency not reported).Strength, lot# and expiry date were not provided for all suspects.Action taken with the newly added suspect mometasone furoate (manufacturer unknown) was unknown.The causality assessment was not reported.Upon internal review on 04-oct-2023, the report was downgraded and its was no longer a malfunction as now with the recent follow-up it was unknown.Local comments: this report no longer meets criteria for submission.
|
| |
|
Search Alerts/Recalls
|
|
|
