Description of Event or Problem · 1
SJOGREN'S SYNDROME WITH KERATOCONJUNCTIVITIS SICCA/ SICCA SYNDROME [SJOGREN'S SYNDROME] ([KERATOCONJUNCTIVITIS SICCA], [ANTI-SS-A ANTIBODY POSITIVE]). POSITIVE FOR IMMUNOCOMPROMISED STATE [IMMUNOCOMPROMISED]. HYPERTHYROIDISM [HYPERTHYROIDISM] ([T3 INCREASED], [T4 INCREASED], [FATIGUE], [MUSCLE PAIN]). RIGHT-SIDED ILIOTIBIAL BAND SYNDROME [ILIOTIBIAL BAND SYNDROME]. ARTICULAR GOUT [ARTICULAR GOUT]. HYPERCHOLESTEROLEMIA [HYPERCHOLESTEROLEMIA]. LUMBAR DEGENERATIVE DISC DISEASE [DEGENERATIVE DISC DISEASE]. INTERFERES WITH HER DAILY ACTIVITIES [ACTIVITIES OF DAILY LIVING IMPAIRED]. OSTEOPENIA OF RIGHT FEMORAL NECK [OSTEOPENIA]. SHE WAS TAKING LIOTHYRONINE, DID DEVELOP TOXICITY [DRUG TOXICITY]. SYNVISC ADMINISTERED IN BILATERAL JAWS [OFF LABEL USE]. CASE NARRATIVE: THIS CASE IS CROSS REFERENCED WITH (B)(4) (MULTIPLE DEVICES USED). INITIAL INFORMATION RECEIVED ON 01-JUL-2019 REGARDING A SOLICITED VALID SERIOUS CASE RECEIVED FROM A PHYSICIAN, IN THE SCOPE OF PATIENT SUPPORT PROGRAM "(B)(6)". PATIENT ID: (B)(6); COUNTRY: UNITED STATES; STUDY TITLE: (B)(6). THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO EXPERIENCED SJOGREN'S SYNDROME WITH KERATOCONJUNCTIVITIS SICCA/ SICCA SYNDROME, POSITIVE FOR IMMUNOCOMPROMISED STATE, HYPERTHYROIDISM, RIGHT-SIDED ILIOTIBIAL BAND SYNDROME, ARTICULAR GOUT, HYPERCHOLESTEROLEMIA, LUMBAR DEGENERATIVE DISC DISEASE, SHE WAS TAKING LIOTHYRONINE, DID DEVELOP TOXICITY, INTERFERES WITH HER DAILY ACTIVITIES, SYNVISC ADMINISTERED IN BILATERAL JAWS AND OSTEOPENIA OF RIGHT FEMORAL , WHILE SHE WAS TREATED WITH LIOTHYRONINE SALT NOT SPECIFIED AND AFTER THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC). (LATENCY: UNKNOWN) THE PATIENT'S PAST MEDICAL HISTORY INCLUDED LYME DISEASE AND HYSTERECTOMY. HER PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING CHRONIC LOW BACK PAIN. CONCOMITANT MEDICATIONS INCLUDED HYDROXYCHLOROQUINE AND AZITHROMYCIN (ZITHROMAX). ON AN UNKNOWN DATE, THE PATIENT TOOK HYLAN G-F 20, SODIUM HYALURONATE INJECTION AT THE UNKNOWN DOSAGE AT UNKNOWN FREQUENCY VIA UNKNOWN ROUTE IN LEFT JAW (LOT-UNKNOWN; INFORMATION FOR BATCH NUMBER REQUESTED) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2019, PATIENT VISITED TO HEALTHCARE FACILITY AND DURING EVALUATION IT WAS REPORTED THAT PATIENT TOOK HYLAN G-F 20, SODIUM HYALURONATE INJECTION IN JAWS. DURING THE EVALUATION, SHE WAS OBSERVED THAT ANTI-SSA POSITIVE SJOGREN'S DISEASE ON CEVIMELINE OFF OF HYDROXYCHLOROQUINE, RIGHT-SIDED ILIOTIBIAL BAND SYNDROME, QUESTIONABLE ARTICULAR GOUT ON TAPERING DOSES OF ALLOPURINOL, HYPERTHYROIDISM, HYPERCHOLESTEROLEMIA, STATUS POST TOTAL HYSTERECTOMY. SHE RECEIVED AZITHROMYCIN FOR ABOUT A YEAR FOR QUERY DIAGNOSIS OF LYME DISEASE, AND HAD CHRONIC LOW BACK PAIN, MRI REVEALED LUMBAR DEGENERATIVE DISC DISEASE. SHE WAS TAKING LIOTHYRONINE, DID DEVELOP TOXICITY, TRANSITIONED TO LEVOTHYROXINE, AND MORE RECENTLY FOUND TO HAVE ELEVATED T3/T4 AND METHIMAZOLE INITIATED. SHE ALSO REPORTED THAT SHE HAD SIGNIFICANT FATIGUE WITH MUSCLE PAIN THAT INTERFERES WITH HER DAILY ACTIVITIES. SHE WAS ALSO OBSERVED POSITIVE FOR IMMUNOCOMPROMISED STATE. ON THE UNKNOWN DATE, IT WAS OBSERVED THAT SEDIMENTATION RATE WAS 10 MM/HOUR (0-25). SHE WAS ALSO DIAGNOSED WITH OSTEOPENIA OF RIGHT FEMORAL NECK. THE EVENT OF SJOGREN'S SYNDROME WITH KERATOCONJUNCTIVITIS SICCA/ SICCA SYNDROME WAS ASSESSED AS SERIOUS DUE TO SERIOUSNESS CRITERIA OF MEDICALLY SIGNIFICANT. THE EVENT OF POSITIVE FOR IMMUNOCOMPROMISED STATE WAS ASSESSED AS SERIOUS DUE TO SERIOUSNESS CRITERIA OF MEDICALLY SIGNIFICANT. THE EVENT OF HYPERTHYROIDISM WAS ASSESSED AS SERIOUS DUE TO SERIOUSNESS CRITERIA OF MEDICALLY SIGNIFICANT FINAL DIAGNOSIS WAS SYNVISC ADMINISTERED IN BILATERAL JAWS, INTERFERES WITH HER DAILY ACTIVITIES, MUSCLE PAIN, SIGNIFICANT FATIGUE, SHE WAS TAKING LIOTHYRONINE, DID DEVELOP TOXICITY, LUMBAR DEGENERATIVE DISC DISEASE, HYPERCHOLESTEROLEMIA, ARTICULAR GOUT, RIGHT-SIDED ILIOTIBIAL BAND SYNDROME, HYPERTHYROIDISM, POSITIVE FOR IMMUNOCOMPROMISED STATE, SJOGREN'S SYNDROME WITH KERATOCONJUNCTIVITIS SICCA/ SICCA SYNDROME AND OSTEOPENIA OF RIGHT FEMORAL NECK. ACTION TAKEN: UNKNOWN FOR ALL THE EVENTS IN CASE OF DEVICE HYLAN G-F 20, SODIUM HYALURONATE; DRUG WITHDRAWN FOR HYPERTHYROIDISM AND SHE WAS TAKING LIOTHYRONINE, DID DEVELOP TOXICITY, NOT APPLICABLE FOR SYNVISC ADMINISTERED IN BILATERAL JAWS AND UNKNOWN FOR REST OF THE EVENTS. CORRECTIVE TREATMENT: ALLOPURINOL (ALLOPURINOL) FOR ARTICULAR GOUT, LEVOTHYROXINE (LEVOTHYROXINE) AND METHIMAZOLE (METHIMAZOLE) FOR HYPERTHYROIDISM; NOT REPORTED FOR REST OF THE EVENTS OUTCOME: RECOVERING FOR OSTEOPENIA OF RIGHT FEMORAL NECK, SJOGREN'S SYNDROME WITH KERATOCONJUNCTIVITIS SICCA/ SICCA SYNDROME, ARTICULAR GOUT, FATIGUE, LUMBAR DEGENERATIVE DISC DISEASE AND UNKNOWN FOR REST OF THE EVENTS. REPORTER CAUSALITY: UNASSESSABLE IN CASE OF HYLAN G-F 20, SODIUM HYALURONATE; NOT REPORTED FOR LIOTHYRONINE. COMPANY CAUSALITY: NOT REPORTABLE FOR ALL THE EVENTS IN CASE OF HYLAN G-F 20, SODIUM HYALURONATE; LIOTHYRONINE. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED, AND RESULTS WERE PENDING FOR SAME.