Description of Event or Problem · 1
DESCRIPTION OF EVENT OR PROBLEM: THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS RECEIVED FROM A CONSUMER, WHICH WAS LATER MEDICALLY CONFIRMED BY AN ORTHOPEDIC PHYSICIAN IN THE UNITED STATES. THE PT, A (B)(6) FEMALE EXPERIENCED INCREASED BLOOD PRESSURE, SWELLING ON THE RIGHT KNEE AT THE AREA OF THE INJECTION, PAIN AT THE INJECTION SITE ON THE LEFT KNEE, DIZZINESS, FEELING OFF BALANCE, EXCESSIVE SLEEPING, FATIGUE, BACK PAIN, NAUSEA AND CONSTIPATION AFTER RECEIVING THREE EUFLEXXA ((B)(4)) INJECTIONS (LOT NUMBER AND EXPIRATION DATE UNK) IN BOTH KNEES FOR PAIN DUE TO OSTEOARTHRITIS. ON (B)(6) 2012, THE PT RECEIVED THE FIRST EUFLEXXA INJECTION IN BOTH KNEES FOR PAIN DUE TO OSTEOARTHRITIS. ON (B)(6) 2012, SHE RECEIVED THE SECOND INJECTION, AND THEN ON (B)(6) 2012, SHE RECEIVED THE THIRD EUFLEXXA INJECTION. ON (B)(6) 2012, THE PT EXPERIENCED SWELLING ON THE RIGHT KNEE AT THE AREA OF THE INJECTION AND PAIN AT THE INJECTION SITE ON THE LEFT KNEE. THE PT REPORTED THAT THE PAIN WAS A NEW PAIN AND DUE TO THE INJECTION SITE BEING SORE. IN (B)(6) 2012, SHE FELT OFF BALANCE, WHICH WAS ATTRIBUTED TO HER MENIERE'S DISEASE AND EXPERIENCED EXCESSIVE SLEEPING. ON (B)(6) 2012, THE PT EXPERIENCED DIZZINESS AND CHECKED HER BLOOD PRESSURE, WHICH WAS 190/100. ON THE SAME DAY, SHE ALSO EXPERIENCED FATIGUE, BACK PAIN AND NAUSEA. THE PT REPORTED THAT SHE BEGAN TO TAKE VERAPAMIL 120 MG OR LOSARTAN 25 MG AS NEEDED FOR ELEVATED BLOOD PRESSURE SIX MONTHS AGO, BUT SHE DID NOT TAKE THEM DAILY DUE TO THE MEDICATIONS CAUSED CONSTIPATION. SHE STATED THAT THE CONSTIPATION CAUSED BACK PAIN. ON (B)(6) 2012, SHE RECEIVED VERAPAMIL DUE TO THE INCREASED BLOOD PRESSURE. ON (B)(6) 2012, THE BLOOD PRESSURE READING WAS 129/81. ON (B)(6) 2012, SHE TOOK ANOTHER DOSE OF VERAPAMIL. ON (B)(6) 2012, THE BLOOD PRESSURE READING WAS 158/86, 170/106 AND 168/104. SHE STATED THAT SHE USED THE BLOOD PRESSURE MACHINE AT HOME, WHICH CHECKED BLOOD PRESSURE THREE TIMES IN A ROW. SHE DID NOT KNOW HOW LONG OF A TIME WAS BETWEEN EACH READING. ON (B)(6) 2012, SHE RECEIVED LOSARTAN FOR ELEVATED BLOOD PRESSURE. ON (B)(6) 2012, THE BLOOD PRESSURE READING WAS 167/91, 152/87, AND 147/89. ON (B)(6) 2012, THE BLOOD PRESSURE READING WAS 173/95 AND 158/90. ON (B)(6) 2012, BLOOD PRESSURE READING WAS 157/102, 145/93 AND 132/95. THE PT REPORTED THAT THE BLOOD PRESSURE REMAINED ELEVATED EVEN WHEN SHE TOOK THE BLOOD PRESSURE MEDICATIONS. SHE STATED THAT SHE DID NOT NEED TO TAKE THE MEDICATIONS SO FREQUENTLY. SHE CONTINUED TO HAVE FATIGUE, SLEPT DURING THE DAY AND SLEPT LONGER AT NIGHT. THE PT REPORTED THAT THE PRIMARY CARE PHYSICIAN ADVISED THE PT TO CONTINUE THE BLOOD PRESSURE MEDICATIONS AS NEEDED. THE ORTHOPEDIC PHYSICIAN REPORTED THAT THE PT WAS ADVISED TO TAKE LOSARTAN DAILY INSTEAD OF AS NEEDED, CHECK BLOOD PRESSURE REGULARLY AND TO TAKE COLACE (DOCUSATE) FOR CONSTIPATION. THE PT WAS ALSO ADVISED TO CONTINUE WITH ADVIL AS NEEDED FOR PAIN AND SWELLING AND APPLY ICE TO THE AREA. THE OUTCOME OF THE EVENTS OF SWELLING ON THE RIGHT KNEE AT THE AREA OF INJECTION, FEELING OFF BALANCE, EXCESSIVE SLEEPING, CONSTIPATION, DIZZINESS AND BACK PAIN WERE ONGOING. THE PT WAS RECOVERING FROM THE INCREASED BLOOD PRESSURE, NAUSEA AND FATIGUE. THE PT WAS RECOVERING FROM THE PAIN AT THE INJECTION SITE ON THE LEFT KNEE WITH ADVIL (IBUPROFEN). THE ORTHOPEDIC SURGEON REPORTED THE CAUSALITY FOR BLOOD PRESSURE INCREASED, FATIGUE AND BACK PAIN TO BE POSSIBLY RELATED TO EUFLEXXA. THE CAUSALITY FOR THE SWELLING ON RIGHT KNEE AT THE AREA OF INJECTION AND PAIN AT THE INJECTION SITE ON THE LEFT KNEE WERE PROBABLY RELATED. THE CAUSALITY FOR DIZZINESS, FEELING OFF BALANCE, CONSTIPATION AND NAUSEA WERE UNLIKELY AND FOR THE EXCESSIVE SLEEPING WAS UNRELATED TO EUFLEXXA INJECTIONS. MEDICAL HISTORY WAS PROVIDED AND INCLUDED MULTIPLE DRUG ALLERGIES, VESTIBULAR NERVE BEING SEVERED TO TREAT MENIERE'S DISEASE IN 1970. IN 2011, DIAGNOSED WITH OSTEOARTHRITIS OF THE KNEES MILD TO MODERATE. MANY ENVIRONMENTAL AND FOOD SENSITIVITIES. VERAPAMIL AND LOSARTAN CAUSED CONSTIPATION. CONCOMITANT MEDICATIONS WERE PROVIDED AND INCLUDED VITAMINS. ADD'L INFO WAS RECEIVED ON (B)(6) 2012, FROM A PHYSICIAN. START DATE, OUTCOME AND REPORTER CAUSALITY FOR THE ADVERSE EVENTS PROVIDED. TREATMENT RECOMMENDATIONS WERE PROVIDED. UPDATED CONCOMITANT MEDICATIONS AND MEDICAL HISTORY. IF NEW SIGNIFICANT INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. COMPANY COMMENTS: PT HAS A HISTORY OF ELEVATED BLOOD PRESSURE TREATED WITH MEDICATION; FURTHER DETAILS NOT PROVIDED. BLOOD PRESSURE INCREASED AFTER EUFLEXXA USE; BLOOD PRESSURE MEDICATION MODIFIED. INSUFFICIENT INFO TO EVALUATE CAUSALITY, ALTHOUGH A CAUSAL OR EXACERBATION CANNOT BE RULED OUT.