Description of Event or Problem · 1
INITIAL INFO RECEIVED FROM AN OFFICE STAFF MEMBER ON (B)(6) 2010: A FEMALE PATIENT HAS BEEN TREATED WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT# AND EXP DATE UNK) EXPERIENCED EXERCISE-INDUCED HEADACHES AFTER RECEIVING POLY-L-LACTIC ACID. SHE STATED THAT SHE EXPERIENCES THESE AROUND THE TIME SHE RECEIVES THE POLY-L-LACTIC ACID TREATMENTS AND THAT THEY GO AWAY "AS TIME PASSES AFTER THE TREATMENTS." SHE REPORTED THAT EACH DAY THEY GET BETTER AND BETTER. IT IS UNK THE NUMBER OF TREATMENTS THE PATIENT HAS RECEIVED. HOWEVER, SHE MAY HAVE RECEIVED 2 OR 3 TREATMENTS. NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY REPORTED. NO FURTHER INFO REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THIS CASE INVOLVING A FEMALE PT WHO REPORTEDLY EXPERIENCED RECURRENT HEADACHES IN ASSOCIATION WITH SCULPTRA ADMINISTRATION LACKS SUFFICIENT INFO FOR A COMPLETE MEDICAL ASSESSMENT. GIVEN THAT THE PATIENT REPORTED THESE HEADACHES AS "EXERCISE-INDUCED", A MORE LIKELY ETIOLOGY IS EXERCISE (PERHAPS DUE TO FLUID DEPLETION/ LACK OF PROPER HYDRATION), AS OPPOSED TO BEING DRUG-INDUCED OR DRUG-RELATED. ADD'L INFO IS NEEDED INCLUDING MEDICAL CONFIRMATION OF THIS EVENT, PATIENT'S DEMOGRAPHICS, MEDICAL HISTORY AND RISK FACTORS, DETAILS OF CONCOMITANT MEDICATIONS, DETAILS OF SUSPECT DRUG ADMINISTRATION (DOSAGE RECEIVED, RECONSTITUTION TECHNIQUE USED, LOCATION OF SCULPTRA INJECTIONS, THERAPY DATES, ETC.), DETAILS OF CORRECTIVE TREATMENT PROVIDED, AND FINAL OUTCOME.