DUROLANE

Description of Event or Problem

AS REPORTED A PATIENT EXPERIENCED HIVES, RASH, FAINTING, DIZZINESS, AND INJECTION SITE SWELLING FOLLOWING INTRA-ARTICULAR INJECTION OF DUROLANE.

Additional Manufacturer Narrative

IT WAS REPORTED A PATIENT EXPERIENCED HIVES, RASH, FAINTING, DIZZINESS, AND INJECTION SITE SWELLING FOLLOWING INTRA-ARTICULAR INJECTION OF DUROLANE. ASSESSMENT BY CLINICAL AFFAIRS DETERMINED THE EVENT TYPE IS SUSPECTED TO BE A SERIOUS ADVERSE EVENT DUE TO HOSPITALIZATION FOLLOWING DUROLANE INJECTION. HIVES AND GENERALIZED RASH ARE SUGGESTIVE OF SYSTEMIC ALLERGIC REACTION. FAINTING AND DIZZINESS ARE POSSIBLE ANAPHYLACTIC REACTIONS. THE DUROLANE INSTRUCTIONS FOR USE (IFU) SPECIFIES INCIDENCES OF RASH, HIVES, AND DIZZINESS HAVE BEEN REPORTED IN ASSOCIATION WITH INTRA-ARTICULAR INJECTION. THE IFU IDENTIFIES HYPERSENSITIVITY REACTIONS (RASH AND SWELLING) AS KNOWN RISKS, BUT THE SYSTEMIC REACTION WITH HOSPITALIZATION MAY BE CONSIDERED SERIOUS AND REPORTABLE. NO OTHER PATIENT DETAILS ARE PROVIDED, SUCH AS MEDICAL HISTORY AND OTHER LIST OF MEDICATIONS, AND NO LOT NUMBER HAS BEEN PROVIDED. GIVEN THE LACK OF PATIENT DETAILS, CAUSALITY CANNOT BE CONFIRMED FOR PRODUCT OR PROCEDURE, BUT SUSPECTED ADVERSE REACTION IS REASONABLE AND IS DEEMED AS REPORTABLE. ATTEMPTS TO COMPLETE INTERVIEWS WITH THE REPORTER TO OBTAIN ADDITIONAL DETAILS TO SUPPORT THE INVESTIGATION OF THE EVENT ARE ONGOING.

Description of Event or Problem

AS REPORTED A PATIENT WAS HOSPITALIZED WITH HIVES, RASH, FAINTING, DIZZINESS, AND INJECTION SITE SWELLING FOLLOWING INTRA-ARTICULAR INJECTION OF DUROLANE.

Additional Manufacturer Narrative

IT WAS REPORTED BY A FRIEND OF THE FAMILY THAT A PATIENT EXPERIENCED HIVES, RASH, FAINTING, DIZZINESS, AND INJECTION SITE SWELLING FOLLOWING INTRA-ARTICULAR INJECTION OF DUROLANE. THE SUBJECT PRODUCT LOT NUMBER WAS NOT PROVIDED TO SUPPORT INVESTIGATION OF THE ASSOCIATED PRODUCTION LOT.ASSESSMENT BY CLINICAL AFFAIRS DETERMINED THE EVENT TYPE IS SUSPECTED TO BE A SERIOUS ADVERSE EVENT DUE TO HOSPITALIZATION FOLLOWING DUROLANE INJECTION. HIVES AND GENERALIZED RASH ARE SUGGESTIVE OF SYSTEMIC ALLERGIC REACTION. FAINTING AND DIZZINESS ARE POSSIBLE ANAPHYLACTIC REACTIONS.THE DUROLANE INSTRUCTIONS FOR USE (IFU) SPECIFIES INCIDENCES OF RASH, HIVES, AND DIZZINESS HAVE BEEN REPORTED IN ASSOCIATION WITH INTRA-ARTICULAR INJECTION. THE IFU IDENTIFIES HYPERSENSITIVITY REACTIONS (RASH AND SWELLING) AS KNOWN RISKS, BUT THE SYSTEMIC REACTION WITH HOSPITALIZATION MAY BE CONSIDERED SERIOUS AND REPORTABLE. PATIENT OR PROCEDURE DETAILS SUCH AS RELEVANT MEDICAL HISTORY AND OTHER LIST OF MEDICATIONS WERE NOT PROVIDED. ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION TO SUPPORT THE INVESTIGATION OF THE EVENT WERE UNSUCCESSFUL. THEREFORE, CAUSALITY CANNOT BE CONCLUSIVELY CONFIRMED FOR THE PRODUCT OR PROCEDURE. BASED ON ALL INFORMATION AVAILABLE, THE MOST PROBABLE CAUSE CODES FOR THE ADVERSE EVENTS IDENTIFIED IN THE DUROLANE RISK ASSESSMENT, E.G., HIVES, RASH, INJECTION SITE SWELLING ARE INDETERMINATE. THE MOST PROBABLE CAUSE CODES FOR THE REPORTED FAINTING AND DIZZINESS, LIKELY AN ALLERGIC-ANAPHYLACTIC REACTIONS ARE ALSO INDETERMINATE. NO FURTHER INVESTIGATORY ACTIONS WILL BE TAKEN WITHIN THE COMPLAINT RECORD. COMPLAINTS REPORTED AGAINST DUROLANE ON ISSUES RELATED TO HIVES, RASH, ALLERGIC REACTION(S) (FAINTING, DIZZINESS), AND INJECTION SITE SWELLING WILL CONTINUE TO BE MONITORED TO DETERMINE IF ADDITIONAL ACTIONS ASSOCIATED WITH THE REPORTED ISSUES MAY BE INDICATED.