| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Stroke/CVA (1770)
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| Event Date 10/16/2018 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Stroke (cerebrovascular accident) [stroke].Increased level of confusion [confusion].Disorientation [disorientation].Speech difficulties [speech disorder].Case description: this case was reported by a pharmacist via other manufacturer and described the occurrence of stroke in a (b)(6) male patient who received calcium carbonate (tums) unknown for gastrointestinal disorder.Co-suspect products included glycerin (biotene mouthwash (2013 formulation)) mouth wash for product used for unknown indication, dexamethasone tablet for product used for unknown indication, acetylsalicylic acid (aspirin) tablet for product used for unknown indication, cyanocobalamin (vitamin b12) tablet for product used for unknown indication, pantaprazole tablet for product used for unknown indication, lenalidomide (revlimid) for multiple myeloma, epoetin alfa for product used for unknown indication, levothyroxine tablet for an unknown indication, fludrocortisone for product used for unknown indication, colesevelam for product used for unknown indication, loperamide + simethicone for diarrhea, psyllium for product used for unknown indication, colecalciferol (vitamin d3) tablet for product used for unknown indication, calcium ascorbate (ester c) for product used for unknown indication, desalinated sea water, desalinated sea water, desalinated sea water, desalinated sea water (hydrasense) for product used for unknown indication and clotrimazole + hydrocortisone cream for scrotal swelling.The patient's past medical history included thyroidectomy partial.Concurrent medical conditions included multiple myeloma, dvt, amyloidosis, bladder incontinence, chronic diarrhea, recurrent urinary tract infection, diarrhea, clostridium difficile, orthostatic hypotension, anemia, gastrointestinal disorder, scrotal swelling and confusion.On an unknown date, the patient started tums at an unknown dose and frequency and biotene mouthwash (2013 formulation) (oral) at an unknown dose (see dose text).On (b)(6) 2017, the patient started dexamethasone (oral) 8 mg (see dose text) and aspirin 81 mg once daily (81 mg daily).On an unknown date, the patient started vitamin b12 (oral) 1000 ¿g once daily (1000 ¿g daily).On (b)(6) 2017, the patient started pantaprazole (oral) 40 mg once daily (40 mg daily).On (b)(6) 2017, the patient started revlimid (oral) 10 mg once daily (10 mg daily).On an unknown date, the patient started epoetin alfa 40000 at an unknown frequency, levothyroxine (oral) 112 mcg once daily (112 mcg daily) and fludrocortisone.1 mg once daily (.1 mg daily).On (b)(6) 2018, the patient started colesevelam 625 mg once daily (625 mg daily).On an unknown date, the patient started loperamide + simethicone 1 dosage form(s) (see dose text) and psyllium at an unknown dose (see dose text).In (b)(6) 2017, the patient started vitamin d3 1000 iu once daily (1000 iu daily).On an unknown date, the patient started ester c 600 mg once daily (600 mg daily), hydrasense (ocular) at an unknown dose once daily and clotrimazole + hydrocortisone at an unknown dose (see dose text).On (b)(6) 2018, an unknown time after starting tums, biotene mouthwash (2013 formulation) and vitamin b12 and 1 year and 112 days after starting dexamethasone and aspirin, the patient experienced stroke (serious criteria hospitalization, gsk medically significant and life threatening), confusion, disorientation and speech disorder.The action taken with tums was unknown.The action taken with biotene mouthwash (2013 formulation) was unknown.The action taken with dexamethasone was unknown.The action taken with aspirin was unknown.The action taken with vitamin b12 was unknown.The action taken with pantaprazole was unknown.Revlimid was interrupted (dechallenge was negative).Rechallenge with revlimid was unknown.The action taken with epoetin alfa was unknown.The action taken with levothyroxine was unknown.The action taken with fludrocortisone was unknown.The action taken with colesevelam was unknown.The action taken with loperamide + simethicone was unknown.The action taken with psyllium was unknown.The action taken with vitamin d3 was unknown.The action taken with ester c was unknown.The action taken with hydrasense was unknown.The action taken with clotrimazole + hydrocortisone was unknown.On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the confusion, disorientation and speech disorder were not reported.The reporter considered the stroke, confusion, disorientation and speech disorder to be related to tums, biotene mouthwash (2013 formulation), dexamethasone and aspirin.It was unknown if the reporter considered the stroke, confusion, disorientation and speech disorder to be related to vitamin b12.Additional details: the reporter considered the stroke, confusion, disorientation and speech disorder to be related to revlimid.It was the reporter considered the stroke, confusion, disorientation and speech disorder to be related to pantaprazole tablet, epoetin alfa , levothyroxine tablet, fludrocortisone, colesevelam, loperamide + simethicone, psyllium, colecalciferol (vitamin d3) tablet, calcium ascorbate (ester c), hydrasense (sea water), clotrimazole + hydrocortisone cream and midodrine which is he was using as co suspects.There were 18 co-suspect products as per the structured fields.Since the letter was limited to 5 co suspects.Action taken for revlimid and epoetin alfa were temporarily interrupted and action taken for the other suspect medications was not provided (unknown).The reporter assessed the causal relationship suspect medications and stroke as suspected.Initial information was received on 24 oct 2018.The patient had multiple myeloma.Relevant medical history included lambda light chain amyloidosis, orthostatic hypotension, partial thyroidectomy, anemia.On (b)(6) 2018, the patient was admitted to the hospital with increased level of confusion, speech difficulties.A magnetic resonance imaging reveled a stroke.No infectious cause was found.Follow up information received on (b)(6) 2019: co-suspect products included glycerin (biotene mouthwash (2013 formulation)) mouth wash for an unknown indication, dexamethasone tablet for product used for unknown indication, acetylsalicylic acid (aspirin) tablet for product used for unknown indication, cyanocobalamin (vitamin b12) tablet for product used for unknown indication, pantoprazole tablet for an unknown indication, lenalidomide (revlimid) for multiple myeloma, epoetin alfa for product used for unknown indication, levothyroxine tablet for an unknown indication, fludrocortisone for product used for unknown indication, colesevelam for product used for unknown indication, loperamide + simethicone for diarrhea, psyllium for product used for unknown indication, colecalciferol (vitamin d3) tablet for product used for unknown indication, calcium ascorbate (ester c) for product used for unknown indication, clotrimazole + hydrocortisone for scrotal swelling, desalinated sea water (hydrasense) for product used for unknown indication, midodrine hydrochloride, midodrine hydrochloride, midodrine hydrochloride, midodrine hydrochloride (midorine) for an unknown indication, acetylsalicylic acid unknown for product used for unknown indication, ascorbic acid unknown for product used for unknown indication, biotene oralbalance unknown formulation (biotene) unknown for product used for unknown indication, calcium carbonate unknown for gastrointestinal disorder, colesevelam hydrochloride for product used for unknown indication, cyanocobalamin unknown for product used for unknown indication, dexamethasone unknown for product used for unknown indication, fludrocortisone acetate (florinef) unknown for product used for unknown indication, hyaluronate sodium unknown for product used for unknown indication, hydrocortisone acetate cream for scrotal swelling, lenalidomide unknown for plasma cell myeloma, levothyroxine unknown for product used for unknown indication, ambiguous medication nos (midodrine tablet) tablet for product used for unknown indication, pantoprazole unknown for product used for unknown indication, plantago ovata (psyllium husk) unknown for product used for unknown indication, simethicone unknown for diarrhea, fluorine sodium salt + xylitol for product used for unknown indication, loperamide hydrochloride unknown for diarrhea, ambiguous medication nos (midodrine (nos)) unknown for product used for unknown indication, acetylsalicylic acid (aspirin) unknown for product used for unknown indication, clotrimazole unknown for product used for unknown indication and colesevelam hydrochloride unknown for product used for unknown indicationon an unknown date, the patient started tums at an unknown dose and frequency and biotene mouthwash (2013 formulation) (oral) at an unknown dose (see dose text).On (b)(6) 2017, the patient started dexamethasone (oral) 8 mg (see dose text) and aspirin 81 mg once daily (81 mg daily).On an unknown date, the patient started vitamin b12 (oral) 1000 ¿g once daily (1000 ¿g daily).On (b)(6) 2017, the patient started pantoprazole (oral) 40 mg once daily (40 mg daily).On (b)(6) 2017, the patient started revlimid (oral) 10 mg once daily (10 mg daily).On an unknown date, the patient started epoetin alfa 40000 at an unknown frequency, levothyroxine (oral) 112 mcg once daily (112 mcg daily) and fludrocortisone.1 mg once daily (.1 mg daily).On (b)(6) 2018, the patient started colesevelam 625 mg once daily (625 mg daily).On an unknown date, the patient started loperamide + simethicone 1 dosage form(s) and psyllium at an unknown dose.In (b)(6) 2017, the patient started vitamin d3 1000 iu once daily (1000 iu daily).On an unknown date, the patient started ester c 600 mg once daily (600 mg daily), clotrimazole + hydrocortisone at an unknown dose (see dose text), hydrasense (ocular) at an unknown dose once daily, midorine at an unknown dose and frequency, acetylsalicylic acid 81.0999985 mg once daily (81.0999985 mg daily), ascorbic acid 600 mg once daily (600 mg daily), biotene (oral) 2 dosage form(s) once daily (2 dosage form(s) daily), calcium carbonate at an unknown dose and frequency, colesevelam hydrochloride (oral) 625 mg once daily (625 mg daily), cyanocobalamin (oral) 1000 dosage form(s) once daily (1000 dosage form(s) daily), dexamethasone 2 dosage form(s) at an unknown frequency, florinef (unknown).1 mg once daily (.1 mg daily), hyaluronate sodium (ophthalmic) 3 dosage form(s) once daily (3 dosage form(s) daily), hydrocortisone acetate (unknown) 2 dosage form(s) (see dose text), lenalidomide (oral) dosage form(s) (see dose text), levothyroxine (oral) 112 mg at an unknown frequency, midodrine tablet (oral) 5 mg once daily (5 mg daily), pantoprazole (oral) 40 mg once daily (40 mg daily), psyllium husk (unknown) 1 mg once daily (1 mg daily), simethicone (unknown) 120 mg once daily (120 mg daily), fluorine sodium salt + xylitol (oral) at an unknown dose and frequency, loperamide hydrochloride at an unknown dose and frequency, midodrine (nos) (unknown) 5 mg once daily (5 mg daily), aspirin 81.0999985 mg once daily (81.0999985 mg daily), clotrimazole at an unknown dose and frequency and colesevelam hydrochloride 625 mg once daily (625 mg daily).On 16th october 2018, an unknown time after starting tums, biotene mouthwash (2013 formulation), vitamin b12, biotene, calcium carbonate and simethicone and 1 year and 112 days after starting dexamethasone, aspirin and pantoprazole, the patient experienced stroke (serious criteria hospitalization, gsk medically significant, life threatening and other: gsk medically significant), confusion, disorientation and speech disorder.The action taken with tums was unknown.The action taken with biotene mouthwash (2013 formulation) was unknown.The action taken with dexamethasone was unknown.The action taken with aspirin was unknown.The action taken with vitamin b12 was unknown.The action taken with pantoprazole was unknown.Revlimid was interrupted (dechallenge was negative).Rechallenge with revlimid was unknown.The action taken with epoetin alfa was unknown.The action taken with levothyroxine was unknown.The action taken with fludrocortisone was unknown.The action taken with colesevelam was unknown.The action taken with loperamide + simethicone was unknown.The action taken with psyllium was unknown.The action taken with vitamin d3 was unknown.The action taken with ester c was unknown.The action taken with clotrimazole + hydrocortisone was unknown.The action taken with hydrasense was unknown.The action taken with acetylsalicylic acid was unknown.The action taken with ascorbic acid was unknown.The action taken with biotene was unknown.The action taken with calcium carbonate was unknown.The action taken with colesevelam hydrochloride was unknown.The action taken with cyanocobalamin was unknown.The action taken with dexamethasone was unknown.The action taken with florinef was unknown.The action taken with hyaluronate sodium was unknown.The action taken with hydrocortisone acetate was unknown.The action taken with lenalidomide was unknown.The action taken with levothyroxine was unknown.The action taken with midodrine tablet was unknown.The action taken with pantoprazole was unknown.The action taken with psyllium husk was unknown.The action taken with simethicone was unknown.The action taken with fluorine sodium salt + xylitol was unknown.The action taken with loperamide hydrochloride was unknown.The action taken with midodrine (nos) was unknown.The action taken with aspirin was unknown.The action taken with clotrimazole was unknown.The action taken with colesevelam hydrochloride was unknown.On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the confusion, disorientation and speech disorder were not reported.
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Manufacturer Narrative
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Mfr report # 3012293-2019-00137 is associated with argus case (b)(4).
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Event Description
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Case description: this case was reported by a pharmacist via other manufacturer and described the occurrence of stroke in a 60-year-old male patient who received calcium carbonate (tums) unknown for gastrointestinal disorder.Co-suspect products included glycerin (biotene mouthwash (2013 formulation)) mouth wash for product used for unknown indication, dexamethasone tablet for product used for unknown indication, acetylsalicylic acid (aspirin) tablet for product used for unknown indication, cyanocobalamin (vitamin b12) tablet for product used for unknown indication, pantaprazole tablet for product used for unknown indication, lenalidomide (revlimid) for multiple myeloma, epoetin alfa for product used for unknown indication, levothyroxine tablet for an unknown indication, fludrocortisone for product used for unknown indication, colesevelam for product used for unknown indication, loperamide + simethicone for diarrhea, psyllium for product used for unknown indication, colecalciferol (vitamin d3) tablet for product used for unknown indication, calcium ascorbate (ester c) for product used for unknown indication, desalinated sea water, desalinated sea water, desalinated sea water, desalinated sea water (hydrasense) for product used for unknown indication and clotrimazole + hydrocortisone cream for scrotal swelling.The patient's past medical history included thyroidectomy partial.Concurrent medical conditions included multiple myeloma, dvt, amyloidosis, bladder incontinence, chronic diarrhea, recurrent urinary tract infection, diarrhea, clostridium difficile, orthostatic hypotension, anemia, gastrointestinal disorder, scrotal swelling and confusion.On an unknown date, the patient started tums at an unknown dose and frequency and biotene mouthwash (2013 formulation) (oral) at an unknown dose (see dose text).On (b)(6) 2017, the patient started dexamethasone (oral) 8 mg (see dose text) and aspirin 81 mg once daily (81 mg daily).On an unknown date, the patient started vitamin b12 (oral) 1000 g once daily (1000 g daily).On (b)(6) 2017, the patient started pantaprazole (oral) 40 mg once daily (40 mg daily).On (b)(6) 2017, the patient started revlimid (oral) 10 mg once daily (10 mg daily).On an unknown date, the patient started epoetin alfa 40000 at an unknown frequency, levothyroxine (oral) 112 mcg once daily (112 mcg daily) and fludrocortisone.1 mg once daily (.1 mg daily).On (b)(6) 2018, the patient started colesevelam 625 mg once daily (625 mg daily).On an unknown date, the patient started loperamide + simethicone 1 dosage form(s) (see dose text) and psyllium at an unknown dose (see dose text).In (b)(6) 2017, the patient started vitamin d3 1000 iu once daily (1000 iu daily).On an unknown date, the patient started ester c 600 mg once daily (600 mg daily), hydrasense (ocular) at an unknown dose once daily and clotrimazole + hydrocortisone at an unknown dose (see dose text).On (b)(6) 2018, an unknown time after starting tums, biotene mouthwash (2013 formulation) and vitamin b12 and 1 year and 112 days after starting dexamethasone and aspirin, the patient experienced stroke (serious criteria hospitalization, gsk medically significant and life threatening), confusion, disorientation and speech disorder.The action taken with tums was unknown.The action taken with biotene mouthwash (2013 formulation) was unknown.The action taken with dexamethasone was unknown.The action taken with aspirin was unknown.The action taken with vitamin b12 was unknown.The action taken with pantaprazole was unknown.Revlimid was interrupted (dechallenge was negative).Rechallenge with revlimid was unknown.The action taken with epoetin alfa was unknown.The action taken with levothyroxine was unknown.The action taken with fludrocortisone was unknown.The action taken with colesevelam was unknown.The action taken with loperamide + simethicone was unknown.The action taken with psyllium was unknown.The action taken with vitamin d3 was unknown.The action taken with ester c was unknown.The action taken with hydrasense was unknown.The action taken with clotrimazole + hydrocortisone was unknown.On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the confusion, disorientation and speech disorder were not reported.The reporter considered the stroke, confusion, disorientation and speech disorder to be related to tums, biotene mouthwash (2013 formulation), dexamethasone and aspirin.It was unknown if the reporter considered the stroke, confusion, disorientation and speech disorder to be related to vitamin b12.Additional details: the reporter considered the stroke, confusion, disorientation and speech disorder to be related to revlimid.It was the reporter considered the stroke, confusion, disorientation and speech disorder to be related to pantaprazole tablet, epoetin alfa , levothyroxine tablet, fludrocortisone, colesevelam, loperamide + simethicone, psyllium, colecalciferol (vitamin d3) tablet, calcium ascorbate (ester c), hydrasense (sea water), clotrimazole + hydrocortisone cream and midodrine which is he was using as co suspects.There were 18 co-suspect products as per the structured fields.Since the letter was limited to 5 co suspects.Action taken for revlimid and epoetin alfa were temporarily interrupted and action taken for the other suspect medications was not provided (unknown).The reporter assessed the causal relationship suspect medications and stroke as suspected.Initial information was received on 24 oct 2018.The patient had multiple myeloma.Relevant medical history included lambda light chain amyloidosis, orthostatic hypotension, partial thyroidectomy, anemia.On (b)(6) 2018, the patient was admitted to the hospital with increased level of confusion, speech difficulties.A magnetic resonance imaging reveled a stroke.No infectious cause was found.Follow up information received on 23 aug 2019: co-suspect products included glycerin (biotene mouthwash (2013 formulation)) mouth wash for an unknown indication, dexamethasone tablet for product used for unknown indication, acetylsalicylic acid (aspirin) tablet for product used for unknown indication, cyanocobalamin (vitamin b12) tablet for product used for unknown indication, pantoprazole tablet for an unknown indication, lenalidomide (revlimid) for multiple myeloma, epoetin alfa for product used for unknown indication, levothyroxine tablet for an unknown indication, fludrocortisone for product used for unknown indication, colesevelam for product used for unknown indication, loperamide + simethicone for diarrhea, psyllium for product used for unknown indication, colecalciferol (vitamin d3) tablet for product used for unknown indication, calcium ascorbate (ester c) for product used for unknown indication, clotrimazole + hydrocortisone for scrotal swelling, desalinated sea water (hydrasense) for product used for unknown indication, midodrine hydrochloride, midodrine hydrochloride, midodrine hydrochloride, midodrine hydrochloride (midorine) for an unknown indication, acetylsalicylic acid unknown for product used for unknown indication, ascorbic acid unknown for product used for unknown indication, biotene oralbalance unknown formulation (biotene) unknown for product used for unknown indication, calcium carbonate unknown for gastrointestinal disorder, colesevelam hydrochloride for product used for unknown indication, cyanocobalamin unknown for product used for unknown indication, dexamethasone unknown for product used for unknown indication, fludrocortisone acetate (florinef) unknown for product used for unknown indication, hyaluronate sodium unknown for product used for unknown indication, hydrocortisone acetate cream for scrotal swelling, lenalidomide unknown for plasma cell myeloma, levothyroxine unknown for product used for unknown indication, ambiguous medication nos (midodrine tablet) tablet for product used for unknown indication, pantoprazole unknown for product used for unknown indication, plantago ovata (psyllium husk) unknown for product used for unknown indication, simethicone unknown for diarrhea, fluorine sodium salt + xylitol for product used for unknown indication, loperamide hydrochloride unknown for diarrhea, ambiguous medication nos (midodrine (nos)) unknown for product used for unknown indication, acetylsalicylic acid (aspirin) unknown for product used for unknown indication, clotrimazole unknown for product used for unknown indication and colesevelam hydrochloride unknown for product used for unknown indicationon an unknown date, the patient started tums at an unknown dose and frequency and biotene mouthwash (2013 formulation) (oral) at an unknown dose (see dose text).On (b)(6) 2017, the patient started dexamethasone (oral) 8 mg (see dose text) and aspirin 81 mg once daily (81 mg daily).On an unknown date, the patient started vitamin b12 (oral) 1000 g once daily (1000 g daily).On (b)(6) 2017, the patient started pantoprazole (oral) 40 mg once daily (40 mg daily).On (b)(6) 2017, the patient started revlimid (oral) 10 mg once daily (10 mg daily).On an unknown date, the patient started epoetin alfa 40000 at an unknown frequency, levothyroxine (oral) 112 mcg once daily (112 mcg daily) and fludrocortisone.1 mg once daily (.1 mg daily).On (b)(6) 2018, the patient started colesevelam 625 mg once daily (625 mg daily).On an unknown date, the patient started loperamide + simethicone 1 dosage form(s) (see dose text) and psyllium at an unknown dose (see dose text).In (b)(6) 2017, the patient started vitamin d3 1000 iu once daily (1000 iu daily).On an unknown date, the patient started ester c 600 mg once daily (600 mg daily), clotrimazole + hydrocortisone at an unknown dose (see dose text), hydrasense (ocular) at an unknown dose once daily, midorine at an unknown dose and frequency, acetylsalicylic acid 81.0999985 mg once daily (81.0999985 mg daily), ascorbic acid 600 mg once daily (600 mg daily), biotene (oral) 2 dosage form(s) once daily (2 dosage form(s) daily), calcium carbonate at an unknown dose and frequency, colesevelam hydrochloride (oral) 625 mg once daily (625 mg daily), cyanocobalamin (oral) 1000 dosage form(s) once daily (1000 dosage form(s) daily), dexamethasone 2 dosage form(s) at an unknown frequency, florinef (unknown).1 mg once daily (.1 mg daily), hyaluronate sodium (ophthalmic) 3 dosage form(s) once daily (3 dosage form(s) daily), hydrocortisone acetate (unknown) 2 dosage form(s) (see dose text), lenalidomide (oral) dosage form(s) (see dose text), levothyroxine (oral) 112 mg at an unknown frequency, midodrine tablet (oral) 5 mg once daily (5 mg daily), pantoprazole (oral) 40 mg once daily (40 mg daily), psyllium husk (unknown) 1 mg once daily (1 mg daily), simethicone (unknown) 120 mg once daily (120 mg daily), fluorine sodium salt + xylitol (oral) at an unknown dose and frequency, loperamide hydrochloride at an unknown dose and frequency, midodrine (nos) (unknown) 5 mg once daily (5 mg daily), aspirin 81.0999985 mg once daily (81.0999985 mg daily), clotrimazole at an unknown dose and frequency and colesevelam hydrochloride 625 mg once daily (625 mg daily).On (b)(6) 2018, an unknown time after starting tums, biotene mouthwash (2013 formulation), vitamin b12, biotene, calcium carbonate and simethicone and 1 year and 112 days after starting dexamethasone, aspirin and pantoprazole, the patient experienced stroke (serious criteria hospitalization, gsk medically significant, life threatening and other: gsk medically significant), confusion, disorientation and speech disorder.The action taken with tums was unknown.The action taken with biotene mouthwash (2013 formulation) was unknown.The action taken with dexamethasone was unknown.The action taken with aspirin was unknown.The action taken with vitamin b12 was unknown.The action taken with pantoprazole was unknown.Revlimid was interrupted (dechallenge was negative).Rechallenge with revlimid was unknown.The action taken with epoetin alfa was unknown.The action taken with levothyroxine was unknown.The action taken with fludrocortisone was unknown.The action taken with colesevelam was unknown.The action taken with loperamide + simethicone was unknown.The action taken with psyllium was unknown.The action taken with vitamin d3 was unknown.The action taken with ester c was unknown.The action taken with clotrimazole + hydrocortisone was unknown.The action taken with hydrasense was unknown.The action taken with acetylsalicylic acid was unknown.The action taken with ascorbic acid was unknown.The action taken with biotene was unknown.The action taken with calcium carbonate was unknown.The action taken with colesevelam hydrochloride was unknown.The action taken with cyanocobalamin was unknown.The action taken with dexamethasone was unknown.The action taken with florinef was unknown.The action taken with hyaluronate sodium was unknown.The action taken with hydrocortisone acetate was unknown.The action taken with lenalidomide was unknown.The action taken with levothyroxine was unknown.The action taken with midodrine tablet was unknown.The action taken with pantoprazole was unknown.The action taken with psyllium husk was unknown.The action taken with simethicone was unknown.The action taken with fluorine sodium salt + xylitol was unknown.The action taken with loperamide hydrochloride was unknown.The action taken with midodrine (nos) was unknown.The action taken with aspirin was unknown.The action taken with clotrimazole was unknown.The action taken with colesevelam hydrochloride was unknown.On an unknown date, the outcome of the stroke was not recovered/not resolved and the outcome of the confusion, disorientation and speech disorder were not reported.Follow up information received on date 09 sep 2019.Patient weight change from 50 kg to 60 kg.On an unknown date, the outcome of the confusion, disorientation and speech disorder were not recovered/not resolved.
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Search Alerts/Recalls
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