Description of Event or Problem · 1
BURNING AT INJECTION SITES, BRAIN SWELLING, OVERDOSE DUE TO PEN NOT WORKING RIGHT [BRAIN EDEMA] CASE DESCRIPTION: 15-DAY ALERT. THIS CASE IS A SPONTANEOUS REPORT FROM A COMPANY SPONSORED SUPPORT PROGRAM REFERRING TO A MALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MOTHER PROVIDED THIS REPORT IN RESPONSE TO A CALL FROM THE PROGRAM VENDOR. PAST MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATIONS OR ALLERGIES WERE REPORTED. IN 2007, THE PATIENT BEGAN TREATMENT WITH NUTROPIN AQ (DOSE AND FREQUENCY NOT REPORTED, SUBCUTANEOUS) FOR AN UNKNOWN INDICATION. THE LOT NUMBER WAS NOT REPORTED. THE LAST DOSE PRIOR TO THE EVENT ONSET WAS NOT REPORTED. ON UNKNOWN DATE, THE PATIENT DEVELOPED BURNING AT INJECTION SITES AND BRAIN SWELLING (BRAIN SWELLING). A MONTH LATER , THE PATIENT RECEIVED ANOTHER DOSE OF NUTROPIN AQ (1.2 MG, FREQUENCY AND ROUTE NOT REPORTED). THE PATIENT DEVELOPED HAND AND FEET SWELLING. NO RELEVANT LABORATORY TESTS OR DIAGNOSTIC EVALUATIONS WERE REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. TREATMENT WITH NUTROPIN WAS REDUCED AT 0.6MG, QD, ROUTE NOT REPORTED. AT THE TIME OF THE REPORT, THE EVENT OUTCOME WAS NOT KNOWN. NO OTHER ETIOLOGICAL INFORMATION WAS REPORTED. THIS EVENT WAS IDENTIFIED AS MEDICALLY SIGNIFICANT BY GENENTECH INC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 22-OCT-2007. CONCURRENT CONDITIONS AT THE TIME OF THE EVENT INCLUDED HYPERCHOLESTEROLEMIA. ON AN UNSPECIFIED DATE IN 2007, THE PATIENT INITIATED TREATMENT WITH NUTROPIN AQ (2.4 MG, SUBCUTANEOUS, Q D) FOR A SMALL PITUITARY. THE LOT NUMBER OF THE NUTROPIN AQ WAS NOT REPORTED. ON AN UNSPECIFIED DATE, APPROXIMATELY ONE WEEK AFTER STARTING NUTROPIN AQ, THE PATIENT EXPERIENCED A VIOLENT HEADACHE, VOMITING AND EDEMA OF THE FEET AND EYELIDS. THE PATIENT WAS SEEN BY AN ENDOCRINOLOGIST WHO DIAGNOSED THE PATIENT WITH SWELLING OF THE BRAIN (BRAIN SWELLING). ON AN UNSPECIFIED DATE, APPROXIMATELY 1 1/2 TO 2 WEEKS LATER, THE PATIENT HAD AN MRI THAT WAS REPORTED AS NORMAL; HOWEVER, THE ENDOCRINOLOGIST STILL ASSESSED THE PATIENT WITH SWELLING OF THE BRAIN. ON AN UNSPECIFIED DATE, THE PATIENT'S OPTIC NERVE WAS ALSO TESTED BY THE ENDOCRINOLOGIST AND THE PATIENT WAS FOUND TO HAVE NO PAPILLEDEMA. PER THE PATIENT'S MOTHER, THE NUTROPIN AQ PEN WAS DIFFICULT TO USE, EVEN FOR HERSELF AS A NURSE. ACCORDING TO THE MOTHER, THE ADVERSE EVENT WAS DUE TO AN OVERDOSE, DUE TO THE PEN NOT WORKING CORRECTLY. THE MOTHER ESTIMATED THE PATIENT RECEIVED APPROXIMATELY TWO AND A HALF TIMES THE REQUIRED DOSE. AT THE TIME OF THIS REPORT, THE PCS NUMBER WAS NOT YET AVAILABLE. THERE WERE NO OTHER CASES ASSOCIATED WITH THIS PRODUCT COMPLAINT. THE FIRST PUNCTURE DATE AND THE PATIENT'S PRIOR HISTORY OF EXPOSURE WITH THIS LOT NUMBER IN QUESTION WERE NOT REPORTED. THE NUTROPIN AQ WAS HELD FOR TWO MONTHS AND THEN RESUMED. AT THIS TIME, INSTEAD OF USING THE NUTROPIN AQ PEN, THE MOTHER WAS USING A SYRINGE, WHICH WAS REPORTED TO BE EASIER TO USE. THE NUTROPIN AQ WAS RESTARTED AT 1.2 MG. THE PATIENT WAS REPORTED TO THEN HAVE A RECURRENCE OF THE HEADACHE AND PERIPHERAL EDEMA. ON AN UNSPECIFIED DATE, THE DOSE WAS REDUCED AGAIN TO 0.6 MG, AND THE PATIENT WAS REPORTED TO NOT EXPERIENCE ANY FURTHER ADVERSE EVENTS. THE DOSE WAS THEN GRADUALLY INCREASED TO 1 MG, SUBCUTANEOUS, QD. AT THE TIME OF THIS REPORT, THE MOTHER DID NOT HAVE THE NUTROPIN AQ LOT NUMBER OR THE PEN NUMBER. THE MOTHER WAS WILLING TO PROVIDE THE PEN FOR EVALUATION. IT WAS NOT REPORTED IF THE PATIENT SWITCHED TO ANOTHER LOT NUMBER OF THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 02-NOV-2007: THIS REPORT WAS FORWARDED TO GENENTECH PRODUCT QUALITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PHARMACOVIGILANCE: BRAIN EDEMA IS UNLABELED IN THE USPI AND UNEXPECTED IN THE IB FOR NUTROPIN. A SPONTANEOUS REPORT OF VIOLENT HEADACHE, VOMITING AND EDEMA OF THE FEET AND EYELIDS, DIAGNOSED AS SWELLING OF THE BRAIN OCCURRING AFTER INITIATING NUTROPIN AQ ADMINISTERED FOR A SMALL PITUITARY IN A MALE PATIENT. NO CONFOUNDING FACTORS ARE REPORTED. THE NUTROPIN AQ WAS HELD AND RESTARTED WITH RECURRENCE OF THE HEADACHE AND PERIPHERAL EDEMA. THIS SERIOUS ADVERSE EVENT IS ASSOCIATED WITH A PRODUCT COMPLAINT.