BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2202429 · Received August 5, 2011

    Report

    Report Number
    9610200-2011-00006
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    May 1, 1999
    Report Date
    July 21, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE FOR THIS CASE-REPORT FROM THE SCIENTIFIC LITERATURE MONITORING: BANERJEE M. EOSINOPHILURIA FROM INTRA-ARTICULAR HYALURONIC ACID INJECTION. CLIN EXP NEPHROL. 2002; 6:248-9. A COPY OF THE ARTICLE IS HEREIN ATTACHED. THIS PAPER WAS PUBLISHED IN 2002 BUT ONLY FOUND IN JUNE 2011. THE REASONS BEHIND THIS LACK OF INFORMATION HAVE BEEN INVESTIGATED WITH THE FOLLOWING RESULTS: THE LOCAL DISTRIBUTOR OF THAT TIME THAT WAS IMMEDIATELY CONTACTED CONFIRMED THAT THIS CASE HAD NEVER BEEN REPORTED TO THEM AS A SPONTANEOUS REPORT. SIMILARLY, NO INFORMATION WAS RECEIVED FROM THE (B)(4) HEALTH AUTHORITIES THAT PROVIDE COMPANIES WITH INFORMATION REGARDING ALL SUSPECTED ADVERSE REACTION REPORTS, WITH AT LEAST ONE SERIOUS REACTION, THEY BECOME AWARE, ON A ROUTINE BASIS. AS A CONSEQUENCE, IT WOULD APPEAR THAT THE HEALTH CARE PROFESSIONAL INVOLVED IN THE PATIENT CARE DID NOT INFORM HIS CA OF THE OCCURRENCE. REGARDING THE COMPANY'S MONITORING OF THE SCIENTIFIC LITERATURE, AT THE TIME, TWO INTERNATIONALLY RECOGNIZED BIOMEDICAL DATABANKS WERE CHECKED ON A WEEKLY BASIS: MEDLINE AND CURRENT CONTENTS; NONE OF THEM INCLUDED THIS ARTICLE. THE JOURNAL, BUT NOT THE ARTICLE, HAS BEEN INDEXED BY MEDLINE AND PUBMED SINCE 2003. REGARDING THE POSSIBLE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE ADMINISTRATION OF HYALGAN, ON THE BASIS OF THE CURRENT KNOWLEDGE OF THE PRODUCT IT CAN BE STATED THAT THERE IS NOT A BIOLOGICALLY PLAUSIBLE MECHANISM JUSTIFYING THE HYPOTHESIS THAT HYALGAN MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO SIMILAR CASES HAVE NEVER BEEN COLLECTED FROM ANY SOURCES, INCLUDED THE SCIENTIFIC LITERATURE MONITORING.

    Description of Event or Problem · 1

    CASE REPORT FROM THE SCIENTIFIC LITERATURE. A (B)(6) MALE, AN EX SMOKER WHO DRANK ALCOHOL IN MODERATION, SUFFERED FROM ISCHEMIC HEART DISEASE, CARDIAC FAILURE, MILD RENAL IMPAIRMENT, HYPERCHOLESTEROLEMIA, AND SEVERE OSTEOARTHRITIS OF BOTH KNEES. HE WAS ON TREATMENT WITH WARFARIN, ISOSORBIDE MONONITRATE, RAMIPRIL, NICORANDIL, AND FUROSEMIDE WITHOUT ANY KNOWN ALLERGIES. HE RECEIVED HYALURONIC ACID INJECTIONS (HYALGAN; SHIRE PHARMACEUTICALS, (B)(6)) IN HIS RIGHT KNEE, 20 MG EVERY WEEK FOR FIVE WEEKS, FOR HIS OSTEOARTHRITIS. AFTER HIS SECOND DOSE, HIS BREATHING WORSENED AND DID NOT IMPROVE WITH SELF TREATMENT BY AN INCREASE IN FUROSEMIDE DOSE. HIS FAMILY DOCTOR NOTED THAT HE WAS FLUID OVERLOADED AND HAD SIGNIFICANT DETERIORATION OF RENAL FUNCTION. HE DENIED ANY SYMPTOMS SUGGESTIVE OF ALLERGIC REACTION DURING OR AFTER THE COURSE OF HYALURONIC ACID INJECTIONS AND HAD NOT HAD ANY CHANGE IN HIS MEDICATIONS IN THE PREVIOUS 6 MONTHS. FINDINGS IN A CARDIOLOGY CLINIC SOON AFTER SHOWED EVIDENCE OF FLUID OVERLOAD. HIS URINE SHOWED MILD PROTEINURIA AND MANY EOSINOPHILS (20-30/HIGH-POWER FIELD), FEW PUS CELLS (15-20/HIGH-POWER FIELD) BUT NO PERIPHERAL EOSINOPHILIA (0.18 X10 TO THE 9TH POWER) WAS NOTED. HIS RENAL IMPAIRMENT WAS PERSISTENT, AND HIS URINE WAS FOUND TO BE STERILE ON CULTURE. A PROVISIONAL DIAGNOSIS OF HYPERSENSITIVITY NEPHRITIS DUE TO HYALURONIC ACID WAS MADE. FURTHER ADMINISTRATION OF HYALURONIC ACID TO THE OTHER KNEE WAS STOPPED, AND HE WAS ASKED TO CONTINUE ON THE SAME MEDICINES AS BEFORE. AFTER 6 MONTHS, HIS CLINICAL SITUATION AS WELL AS HIS RENAL FUNCTION HAD IMPROVED CONSIDERABLY AND NO EOSINOPHILS WERE DETECTED IN THE URINE. RENAL BIOPSY WAS NOT CONSIDERED AS HIS CLINICAL CONDITION WAS IMPROVING. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. AUTHOR'S COMMENT: THIS PATIENT BECAME SYMPTOMATIC SOON AFTER HAVING INTRA-ARTICULAR HYALURONIC ACID. FEATURES CONSISTED OF WORSENING RENAL FUNCTION, WHICH IMPROVED AFTER THE DRUG WAS STOPPED, AND MILD PROTEINURIA AND EOSINOPHILURIA, BUT NO MANIFESTATION OF SYSTEMIC HYPERSENSITIVITY. HYALURONIC ACID, WHICH IS NORMAL CONSTITUENT OF THE BODY, CAN THEREFORE CAUSE A SEVERE HYPERSENSITIVITY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other ISOSORBIDE (ISOSORBIDE MONONITRATE)| NICORANDIL (NICORANDIL)| WARFARIN (WARFARIN SODIUM)| FUROSEMIDE (FUROSEMIDE)| RAMIPRIL (RAMIPRIL)