Description of Event or Problem · 1
INITIAL INFORMATION WAS RECEIVED FROM A NURSE WHO IS ALSO THE PATIENT ON (B)(6) 2011: AN ADULT FEMALE PATIENT RECEIVED ONE TREATMENT OF POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNKNOWN, EXPIRATION DATE UNKNOWN) IN (B)(6) 2011 FOR FACIAL WRINKLES. SHE STATED THAT IN (B)(6) 2011, HER FACILITY WAS PROVIDED POLY-L-LACTIC ACID TRAINING. AT THE END OF THE TRAINING, THERE WAS ONE VIAL OF POLY-L-LACTIC ACID LEFT OVER. THE REPORTER DECIDED TO HAVE THE POLY-L-LACTIC ACID INJECTED FOR HER OWN PERSONAL USE. THE REPORTER STATED THAT A PERIOSTEAL TECHNIQUE WAS USED DURING THE INJECTION PROCEDURE. THE POLY-L-LACTIC ACID WAS USED ON A MONDAY EVENING. THE REPORTER STATED THAT ON THE FOLLOWING SATURDAY, SHE DEVELOPED EXTREME JAW PAIN AND HER LOWER JAW TIGHTENED UP. THE REPORTER STATED THAT 30 MINUTES LATER, SHE DEVELOPED DIFFICULTY BREATHING AND CHEST PAIN. SHE HAS A HISTORY OF CORONARY ARTERY DISEASE AND THAT THE PAIN SHE EXPERIENCED WAS MUCH DIFFERENT THAN CARDIAC PAIN SHE HAD HAD IN THE PAST. SHE TOOK ONE SUBLINGUAL NITROGLYCERIN TABLET FOR THE SYMPTOMS AND ALL OF THE SYMPTOMS WERE RELIEVED BY THE NITROGLYCERIN. SHE HAD SEVERAL MORE SIMILAR EPISODES OVER THE NEXT TWO WEEKS AND ALSO DEVELOPED ELEVATED BLOOD PRESSURE. THE REPORTER STATED THAT AFTER 2-3 WEEKS, THE SYMPTOMS SEEMED TO RESOLVE. THE REPORTER STATED THAT SHE SAW HER CARDIOLOGIST ON (B)(6) 2011 AND THE CARDIOLOGIST INSTRUCTED HER TO CONTINUE MONITORING AND TO NEVER AGAIN USE POLY-L-LACTIC ACID. AS OF (B)(4) 2011, THE REPORTER IS NOT USING SCULPTRA AESTHETIC AND THE REPORTED ADVERSE EVENTS HAVE RESOLVED. NO FURTHER RELEVANT INFORMATION PROVIDED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT (B)(4) 2011: THIS PATIENT HAS A HISTORY OF CARDIAC CHEST PAIN IN THE PAST. THE PAIN WAS A WELL KNOWN SIDE EFFECT ASSOCIATED WITH SCULPTRA INJECTION. HER CARDIAC CHEST PAIN MIGHT HAVE BEEN TRIGGERED BY CHEW PAIN, WHICH FURTHER LED TO BREATHING DIFFICULTY AND ELEVATION OF BLOOD PRESSURE.