| Lot Number 9RSL017 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Therapeutic Response, Decreased (2271); No Code Available (3191)
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| Event Date 01/01/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment follow-up dated 01-sep-2020: this case concerns a patient who received initial treatment with hylan g-f 20, sodium hyaluronate reported that it did not give the expected result.She later received treatment with prednisone and reported having face and body swelling, an absurd jowl, an allergy in the middle of the face which was a type of acne typically caused by corticosteroids and pressure increased.All these symptoms were reported as onset of a cushing's syndrome and patient also experienced stomach pain.Based on the temporal relationship the causal relationship of the device in the occurrence of events cannot be denied and based on the pharmacological plausibility and rechallenge results the causal relationship of prednisone in the occurrence of the events can be evidently established.However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.
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Event Description
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Could be the onset of a cushing's syndrome [cushing's syndrome, steroid-induced] ([acne steroid-induced], [facial swelling], [swelling], [blood pressure increased]).Stomach pain [stomach pain].Vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) [vitamin d increased].There was no effect/not having result/not working/ did not obtain the expected result [device ineffective].Case narrative: based on additional information received on 01-sep-2020, the case initially assessed as non-serious was updated to serious (medically significant for cushing's syndrome).This case is linked to cases, (b)(4).Initial information received from (b)(6) on 27-aug-2020 regarding an unsolicited valid serious case received from patient.This case involves an unknown age female patient who was treated with prednisone (meticorten), hylan g-f 20, sodium hyaluronate (synvisc one) and there was no effect/not having result/not working/ did not obtain the expected result, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.The patient's past medical history, vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 6 ml) at an unknown dose once via unknown route (lot: 9rsl017) in right knee for viscosupplementation.The injection was applied in a doctor's office, they only gave the label with the number of the lot pasted.It was reported patient was not having results and the injection was not working, there was no effect (device ineffective) (onset date: 2020, latency: unknown).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticorten (prednisone) and profenid (ketoprofen).On an unknown date in 2020, the patient started using prednisone (form, route, frequency, dose and batch number: unknown).Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, got an absurd jowl (swelling face) (swelling) and also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: unknown).This event was assessed as serious due to seriousness criteria of medically significant.Patient also reported that she had stomach pain (abdominal pain upper; onset: 2020; latency: unknown) and the pressure increased (blood pressure increased; onset: 2020; latency: unknown).Doctor instructed her to wean the corticosteroid and continue the use of profenid.The patient related that the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned.Currently the patient was only in use of profenid 150 mg, two tablets a day.It was also reported that the fan and rheumatic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she already perform the application.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for there was no effect/not having result/not working/ did not obtain the expected result and unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); drug withdrawn for rest of the events with prednisone.It was not reported if the patient received a corrective treatment for all events the patient outcome is reported as not applicable for there was no effect/not having result/not working/ did not obtain the expected result; not recovered for stomach pain; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); recovering for rest of the events.A product technical compliant (ptc) was initiated with unknown global ptc number and local ptc number: (b)(4).Additional information was received on 01-sep-2020 from the patient.Events added for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.Verbatim updated to there was no effect/not having result/not working/ did not obtain the expected result.Suspect of prednisone added.Clinical course was updated.Text amended accordingly.
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Event Description
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Could be the onset of a cushing's syndrome [cushing's syndrome, steroid-induced] ([acne steroid-induced], [facial swelling], [swelling], [blood pressure increased]) stomach pain [stomach pain] vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) [vitamin d increased] there was no effect/not having result/not working/ did not obtain the expected result [device ineffective] case narrative: based on additional information received on 01-sep-2020, the case initially assessed as non-serious was updated to serious (medically significant for cushing's syndrome).This case is linked to cases, (b)(4).(multiple devices) and (b)(6) (same patient).Initial information received from brazil on 27-aug-2020 regarding an unsolicited valid serious case received from patient.This case involves an unknown age female patient who was treated with prednisone (meticortem), hylan g-f 20, sodium hyaluronate (synvisc one) and there was no effect/not having result/not working/ did not obtain the expected result, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.The patient's past medical history, vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 6 ml) at an unknown dose once via unknown route (lot: 9rsl017; expiration date: 30-apr-2022) in right knee for viscosupplementation.The injection was applied in a doctor's office, they only gave the label with the number of the lot pasted.It was reported patient was not having results and the injection was not working, there was no effect (device ineffective) (onset date: 2020, latency: unknown).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticortem (prednisone) and profenid (ketoprofen).On an unknown date in 2020, the patient started using prednisone (form, route, frequency, dose and batch number: unknown).Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, got an absurd jowl (swelling face) (swelling) and also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: unknown).This event was assessed as serious due to seriousness criteria of medically significant.Patient also reported that she had stomach pain (abdominal pain upper; onset: 2020; latency: unknown) and the pressure increased (blood pressure increased; onset: 2020; latency: unknown).Doctor instructed her to wean the corticosteroid and continue the use of profenid.The patient related that the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned.Currently the patient was only in use of profenid 150mg, two tablets a day.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she already perform the application.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for there was no effect/not having result/not working/ did not obtain the expected result and unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); drug withdrawn for rest of the events with prednisone.It was not reported if the patient received a corrective treatment for all events the patient outcome is reported as not applicable for there was no effect/not having result/not working/ did not obtain the expected result; not recovered for stomach pain; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); recovering for rest of the events.Product technical complaint (ptc) was initiated with global ptc number 100063294 on 27-aug-2020 for product.Batch number; 9rsl017 device not returned.The production and quality control documentation for lot 9rsl017 expiration date apr-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl017 no corrective and preventive action (capa) was required.Sanofi global pharmacovigilance and epidemiology continuously monitor adverse event reports with or without lot numbers, and assess possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 18sep2020 there are 2 complaints on file for lot 9rsl017 and all related sublots.1 complaint is on file for lot 9rsl017a: (1) missing component.1 complaint is on file for lot 9rsl017: (1) adverse event report.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Final investigation complete date: 18-sep-2020 additional information was received on 01-sep-2020 from the patient.Events added for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.Verbatim updated to there was no effect/not having result/not working/ did not obtain the expected result.Suspect of prednisone added.Clinical course was updated.Text amended accordingly.Additional information was received on 18-sep-2020 from healthcare professional.Expiration date added.Global ptc results added.Text was amended accordingly.
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Event Description
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This was because of the corticosteroid, that she must have some allergy to her [specific allergy (drug)].([cushing's syndrome, steroid-induced], [facial swelling], [swelling], [acne steroid-induced], [heart racing], [head pressure], [blood pressure high], [eye discomfort])
stomach pain [stomach pain].Vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) [vitamin d increased].There was no effect/not having result/not working/ did not obtain the expected result/ had zero results [device ineffective].Distrusts the product, thinks that the original drug was not applied this time [suspected counterfeit product].Synvisc one was given by intramuscular route (left knee) [off label use of device].Case narrative: based on additional information received on 01-sep-2020, the case initially assessed as non-serious was updated to serious (medically significant for cushing's syndrome).This case is linked to cases, 2020sa230857, 2020sa238449, 2020sa230860, 2020sa238465, 2020sa238481 (multiple devices) and 2020sa238490 (same patient).Initial information received from brazil on 27-aug-2020 regarding an unsolicited valid serious case received from patient.This case involves a 68 years old female patient (165 cm and 60 kg) who was treated with prednisone (meticortem), hylan g-f 20, sodium hyaluronate (synvisc one) and there was no effect/not having result/not working/ did not obtain the expected result/ had zero results (device ineffective); vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); this was because of the corticosteroid, that she must have some allergy to her (drug hypersensitivity); distrusts the product, thinks that the original drug was not applied this time (suspected counterfeit product), stomach pain.Also, synvisc one was given by intramuscular route (left knee) (off label use of device).The patient's past vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.The past medical history included shoulder pain.Concomitant medication included calcium collagen as a vitamin.The patient got strange that during the consultation with the doctor on july 9-2020, she had only one hylan g-f 20, sodium hyaluronate in the clinic and she would ask for more over the internet.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 6 ml) at an unknown dose once via intramuscular route (lot: 9rsl017; expiration date: 30-apr-2022) in left knee for viscosupplementation for joints and knee pain.The intramuscular use of synvisc one was considered as off label use of device.The injection was applied in a doctor's office, they only gave the label with the number of the lot pasted.It was reported patient was not having results and the injection was not working, there was no effect (device ineffective) (onset date: 2020, latency: unknown).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result.As corrective treatment i.E.The lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticortem (prednisone) and profenid (ketoprofen).On an unknown date in 2020, the patient started using prednisone (form, route, frequency, dose and batch number: unknown).Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, got an absurd jowl (swelling face) (swelling) and the eye wouldn't even open (ocular discomfort) and the patient also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: unknown).This event was assessed as serious due to seriousness criteria of medically significant.She said that some people presented reactions with this corticosteroid, but that's never as sharp as it was for the patient.Patient also reported that she had stomach pain (abdominal pain upper; onset: 2020; latency: unknown) and the pressure increased (onset: 2020; latency: unknown).Patient said she recovered from all the symptoms, and the swelling reduced, she's no longer with any sign she's had before.The doctor instructed her to wean the corticosteroid and continue the use of profenid.The patient related that the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned.On an unknown date in 2020, the patient had her heart was racing, high blood pressure (hypertension), something she never had.The patient was upset with this and she discontinued the medicine on her own.The patient called the doctor who had done the hylan g-f 20, sodium hyaluronate application and prescribed the drug and said she would no longer take the corticosteroid.The physician said that the onset of cushing syndrome and that the symptoms were sure to be a reaction to corticosteroids.As the patient continued to improve after discontinuing prednisone (meticorten), she believed this had nothing to do with hylan g-f 20, sodium hyaluronate.Currently the patient was only in use of profenid 150mg, two tablets a day.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she already perform the application.The only thing that the patient still had was that her pressure still fluctuated.Before the drug, her blood pressure was low, 110mmhg x 80mmhg, 120mmhg x 70mmhg, rarely reached 120mmhg x 80mmhg.After the drug, his blood pressure reached 21.The patient still had it sometimes, felt a pressure in her head (head discomfort).It was informed that patient consulted with a general practitioner, who prescribed her the drug corus as a treatment and told her to only take this medicine when she had any symptoms.So, when she saw she had high on blood pressure, she took a tablet.The doctor said this was because of the corticosteroid, that she must have some allergy to her (drug hypersensitivity).The patient did not understand why the doctor prescribed these drugs meticorten and biprofenid and reportedly the other times she used synvisc with other doctors, the doctor had not passed anything, nor anti-inflammatory and the physician told her to take dipyrone only if she had pain.The application were very fast.About hylan g-f 20, sodium hyaluronate, said it really had no effect on the application.She said it was only when she did the application on her shoulders that the doctor had given her anesthesia before hylan g-f 20, sodium hyaluronate.The other times the patient used it, it had a very fast effect and had done application on both shoulders, had done behind, had done on her knees twice, and had always had a very good result but this time, it had no effect, she felt like crying.It's been three months since she did the application now and had zero results (device ineffective).The patient had doubts about the origin of hylan g-f 20, sodium hyaluronate of this application.It's been 3 years since she used hylan g-f 20, sodium hyaluronate and always had the best results, always fast, on the second day after application she forgot she had the pain.This time the effect was zero and was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.The patient had said she did the application of hylan g-f 20, sodium hyaluronate on her knees and hips this time only, was going to do on the shoulders later but as she had problem with hylan g-f 20, sodium hyaluronate, she did not want to return to the clinic and she applied osteonil plus on the shoulders this time, but the product was not good as hylan g-f 20, sodium hyaluronate, because she was already with shoulder pain, did not help anything.The patient said she saw that they sold hylan g-f 20, sodium hyaluronate on the internet in any corner, so she distrusts the product, thinks that the original drug was not applied this time (suspected counterfeit product; latency: same day of injection).As of (b)(6) 2020, the patient did not get any results.The applications were made by a reputable doctor and clinic.The result, according to the site and package insert, would be for after a month, which did not happen.The hip procedures were guided by ultrasound and everything went well, including knees with direct application.The patient followed the guidelines of the post but, she had not obtained any results until 10-nov-2020, more than 2 full months ago.The patient contacted the sac, when they requested the numbers referring to the batches of products, she sent promptly, thereafter she received no further feedback.She sent emails, with no answers and now she joined via chat.The attendants claim that in addition to the lot number seals, they would have to send a sample of the used syringes, which were discarded at the clinic where the procedures were performed.This information did not appear on the package inserts and on the websites that inform about the product.The patient had already been doing these procedures for more than 4 years (successfully) and this was the first time that the doctor provided the lot number stamps.If there was a possibility of a failure in the result of viscosupplementation with synvisc one, it should be stated at least in the package insert that these items, batch number and product residue, should be kept until the result of the procedure, expected after 30 days.It was an expensive product that promised positive results, minor or major.She had a substantial expense with the procedures, with a negative result.She bought the medicine at a private clinic, where she took the money from the pocket itself, there were 4 injections where it left the loss.She mentioned that users should be warned to keep batch numbers and especially the syringe with residues of the product used.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate not applicable for device ineffective, suspected counterfeit product and off label use of device, unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); drug withdrawn for rest of the events with prednisone.Corrective treatment: losartan potassium (corus) for hypertension; not reported for all other events.The patient outcome is reported as not applicable for device ineffective, suspected counterfeit product and off label use of device; not recovered for abdominal pain upper, hypertension, head discomfort; unknown for vitamin d increased and drug hypersensitivity; recovered for other events.Reporter causality- not related for drug hypersensitivity with hylan g-f 20, sodium hyaluronate
related for drug hypersensitivity with prednisone product technical complaint (ptc) was initiated with global ptc number 100063294 on 27-aug-2020 for product.Batch number; 9rsl017.Device not returned.The production and quality control documentation for lot 9rsl017; expiration date apr-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl017 no corrective and preventive action (capa) was required.Sanofi global pharmacovigilance and epidemiology continuously monitor adverse event reports with or without lot numbers, and assess possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 18sep2020 there are 2 complaints on file for lot 9rsl017 and all related sublots.1 complaint is on file for lot 9rsl017a: (1) missing component.1 complaint is on file for lot 9rsl017: (1) adverse event report.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Final investigation complete date: 18-sep-2020.Additional information was received on 01-sep-2020 from the patient.Events added for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.Verbatim updated to there was no effect/not having result/not working/ did not obtain the expected result.Suspect of prednisone added.Clinical course was updated.Text amended accordingly.Additional information was received on 18-sep-2020 from healthcare professional.Expiration date added.Global ptc results added.Text was amended accordingly.Additional information was received on 20-oct-2020 from patient.Events of this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time were added.Symptoms and their details updated.Verbatim of event there was no effect/not having result/not working/ did not obtain the expected result/ had zero results.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.Additional information was received on 10-nov-2020 from a patient.Indication and route of synvisc one was updated.Event- synvisc one was given by intramuscular route (left knee) (off label use of device) was added.Concomitant medication was added.Clinical course updated.Text amended accordingly.
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Event Description
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This was because of the corticosteroid, that she must have some allergy to her.Specific allergy (drug), cushing's syndrome, steroid-induced, facial swelling, swelling, acne steroid-induced, heart racing, head discomfort, blood pressure high, eye discomfort.Stomach pain [stomach pain].Vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), vitamin d increased.There was no effect/not having result/not working/ did not obtain the expected result/ had zero results, device ineffective.Distrusts the product, thinks that the original drug was not applied this time, suspected counterfeit product.Case narrative: based on additional information received on 01-sep-2020, the case initially assessed as non-serious was updated to serious, medically significant for cushing's syndrome.This case is linked to cases,(b)(6) (multiple devices) and (b)(6) (same patient).Initial information received from brazil on 27-aug-2020 regarding an unsolicited valid serious case received from patient.This case involves an unknown age female patient who was treated with prednisone (meticortem), hylan g-f 20, sodium hyaluronate (synvisc one) and there was no effect/not having result/not working/ did not obtain the expected result/ had zero results, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time were added, stomach pain.The patient's past vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.The past medical history included shoulder pain.The patient got stranged that during the consultation with the doctor on (b)(6) 2020, she had only one hylan g-f 20, sodium hyaluronate in the clinic and she would ask for more over the internet.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate (strength: 6 ml) at an unknown dose once via unknown route (lot: 9rsl017; expiration date: 30-apr-2022) in right knee for viscosupplementation.The injection was applied in a doctor's office, they only gave the label with the number of the lot pasted.It was reported patient was not having results and the injection was not working, there was no effect (device ineffective) (onset date: 2020, latency: unknown).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result.As corrective treatment i.E.The lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticortem (prednisone) and profenid (ketoprofen).On an unknown date in 2020, the patient started using prednisone (form, route, frequency, dose and batch number: unknown).Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, got an absurd jowl (swelling face) (swelling) and the eye wouldn't even open (ocular discomfort) and the patient also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: unknown).This event was assessed as serious due to seriousness criteria of medically significant.Patient also reported that she had stomach pain (abdominal pain upper; onset: 2020; latency: unknown) and the pressure increased (onset: 2020; latency: unknown).The doctor instructed her to wean the corticosteroid and continue the use of profenid.The patient related that the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned.On an unknown date in 2020, the patient had her heart was racing, high blood pressure (hypertension), something she never had.The patient was upset with this and she discontinued the medicine on her own.The patient called the doctor who had done the hylan g-f 20, sodium hyaluronate application and prescribed the drug and said she would no longer take the corticosteroid.The physician said that the onset of cushing syndrome and that the symptoms were sure to be a reaction to corticosteroids.As the patient continued to improve after discontinuing prednisone (meticorten), she believed this had nothing to do with hylan g-f 20, sodium hyaluronate.Currently the patient was only in use of profenid 150mg, two tablets a day.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she already perform the application.The only thing that the patient still had was that her pressure still fluctuated.Before the drug, her blood pressure was low, 110mmhgx80mmhg, 120mmhgx70mmhg, rarely reached 120mmhgx80mmhg.After the drug, his blood pressure reached 21.The patient still had it sometimes, got a snap to her head (head discomfort).The general practitioner prescribed her the drug corus as a treatment and told her to only take this medicine when she had any symptoms.So when she saw she had high on blood pressure, she took a tablet.The doctor said this was because of the corticosteroid, that she must have some allergy to her.The patient did not understand why the doctor prescribed these drugs meticorten and biprofenid and reportedly the other times she used synvisc with other doctors, the doctor had not passed anything, nor anti-inflammatory and told her to take dipyrone only if she had pain.The application were very fast.About hylan g-f 20, sodium hyaluronate, said it really had no effect on the application.The other times the patient used it, it had a very fast effect and had done application on both shoulders, had done behind, had done on her knees twice, and had always had a very good result but this time, it had no effect, she felt like crying.It's been three months since she did the application now and had zero results (device ineffective).The patient had doubts about the origin of hylan g-f 20, sodium hyaluronate of this application.It's been 3 years since she used hylan g-f 20, sodium hyaluronate and always had the best results, always fast, on the second day after application she forgot she had the pain.This time the effect was zero and was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.The patient had said she did the application of hylan g-f 20, sodium hyaluronate on her knees and hips this time only, was going to do on the shoulders later but as she had problem with hylan g-f 20, sodium hyaluronate, she did not want to return to the clinic and she applied osteonil plus on the shoulders this time, but the product was not good as hylan g-f 20, sodium hyaluronate , because she was already with shoulder pain, did not help anything.The patient said she saw that they sold hylan g-f 20, sodium hyaluronate on the internet in any corner, so she distrusts the product, thinks that the original drug was not applied this time (suspected counterfeit product).Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for there was no effect/not having result/not working/ did not obtain the expected result/ had zero results, suspected counterfeit product and unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); drug withdrawn for rest of the events with prednisone.It was not reported if the patient received a corrective treatment for all events.The patient outcome is reported as not applicable for there was no effect/not having result/not working/ did not obtain the expected result/ had zero results, suspected counterfeit product; not recovered for stomach pain, pressure increased/ high blood pressure and gets a snap to her head; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and this was because of the corticosteroid, that she must have some allergy to her; recovered for other events.Reporter causality- not related for drug hypersensitivity with hylan g-f 20, sodium hyaluronate; related for drug hypersensitivity with prednisone.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6)2020 for product.Batch number; 9rsl017.Device not returned.The production and quality control documentation for lot 9rsl017 expiration date apr-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl017 no corrective and preventive action (capa) was required.Sanofi global pharmacovigilance and epidemiology continuously monitor adverse event reports with or without lot numbers, and assess possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 18sep2020 there are (b)(4) complaints on file for lot 9rsl017 and all related sublots.(b)(4) complaint is on file for lot 9rsl017a: (1) missing component.(b)(4) complaint is on file for lot 9rsl017: (1) adverse event report.Sanofi would continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required.Final investigation complete date: (b)(4) 2020.Additional information was received on 01-sep-2020 from the patient.Events added for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), could be the onset of a cushing's syndrome, stomach pain.Verbatim updated to there was no effect/not having result/not working/ did not obtain the expected result.Suspect of prednisone added.Clinical course was updated.Text amended accordingly.Additional information was received on 18-sep-2020 from healthcare professional.Expiration date added.Global ptc results added.Text was amended accordingly.Additional information was received on 20-oct-2020 from patient.Events of this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time were added.Symptoms and their details updated.Verbatim of event there was no effect/not having result/not working/ did not obtain the expected result/ had zero results.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.
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