Description of Event or Problem · 1
IN 2005, A DENTAL PRACTICE USED SARGENTI RC2B ROOT CANAL PASTE CONTAINING PARAFORMALDEHYDE, LEAD AND MERCURY DURING A ROOT CANAL ON TOOTH #18. AN OVERFILL OCCURRED INTO MY MANDIBULAR NERVE CHANNEL. MY INFERIOR ALVEOLAR NERVE WAS PERMANENTLY DAMAGED AND SINCE THE DENTISTS FAILED TO DISCLOSE THE OVERFILL, OR THE USE OF SARGENTI PASTE, MY ABILITY TO HAVE THE OVERFILL REMOVED BEFORE PERMANENT, DEBILITATING DAMAGE WAS DONE WAS LOST. SARGENTI PASTE, AKA N2, RC2B, RC2W, ONE STEP ENDODONTIC WHITE, N2 UNIVERSAL, ETC.. HAS NOT BEEN APPROVED BY THE FDA AND ON FEB. 12, 1993 WAS DENIED NDA APPROVAL BECAUSE THE SAFETY AND EFFICACY OF THE MATERIAL HAD NOT BEEN PROVEN -HTTP://WWW.DENTALWATCH.ORG/QUESTIONABLE/ARGENTI/HEARING-1993-.RTF-. I NOW SUFFER FROM PERMANENT NUMBNESS AND DEBILITATING BURNING PAIN IN MY LOWER LEFT LIP, CHIN, AND JAW WHICH REQUIRES EXTENSIVE MEDICATIONS TO REDUCE PAIN. NOTHING ELIMINATES IT; THEREFORE, I AM LEFT WITH 24/7 PAIN AND SUFFERING. ANTI DEPRESSANTS ARE USED TO TREAT THIS CONDITION. THE FDA RECENTLY CAME OUT WITH A WARNING THAT ANTIDEPRESSANTS CAN CAUSE DANGEROUS SIDE EFFECTS ON PTS, SUCH AS INCREASED SUICIDAL ATTEMPTS. WHY WOULD YOU ALLOW AN ILLEGAL DRUG/DEVICE TO BE USED THAT WHEN DAMAGE OCCURS REQUIRES YET ANOTHER DANGEROUS DRUG TO COUNTERACT? THE PROPONENTS OF SARGENTI PASTE, N2 PRODUCTS, CLAIM THAT RC2B, RC2W ARE GENERICS FOR N2 UNIVERSAL AND THEREFORE, THE GENERICS ARE BEING USED BEFORE THE APPROVAL OF THE NON-GENERIC N2. HOW IS THIS ALLOWED TO HAPPEN? THE AMERICAN ENDODONTIC SOCIETY, WHICH SUPPORTS THE N2 PRODUCTS NDA ACTIVITIES, CLAIMS IN ONE OF THEIR NEWSLETTERS THAT THE FDA HAS APPROVED THE SAFETY AND EFFICACY OF N2. THIS IS NOT TRUE. WHY CAN THE FDA NOT DO SOMETHING TO STOP THE FALSE ADVERTISING OF THE STATUS OF SARGENTI PASTES? HOW CAN A GENERIC VERSION OF AN UNAPPROVED DRUG BE ALLOWED ON THE MARKET? SMALL COMPOUNDING PHARMACIES ARE MAKING THIS MATERIAL, SELLING IT IN BULK QUANTITIES INTERSTATE AGAINST THE FDA POSITION THAT STATES SHIPMENTS OF 5 GRAMS OR LESS ARE GRANTED A PHARMACY EXEMPTION. THE PHARMACY, WAS SELLING INTERSTATE TO MY DENTISTS IN QUANTITIES OF 6 TIMES THE FDA ALLOWED LIMIT PER A 1991 COMMISSIONER LETTER THAT THE FDA HAS AFFIRMED REMAINS ITS POSITION TODAY. THERE ARE OTHER PHARMACIES THAT HAVE BEEN FOUND SELLING ROOT CANAL PASTES WITH PARAFORMALDEHYDE CONTENTS OF 46% AND 98% IN INTERSTATE COMMERCE. THE FDA NEEDS TO ENFORCE THEIR OWN LAWS AND STOP THE USE OF ANY PARAFORMALDEHYDE CONTAINING ROOT CANAL MATERIALS UNLESS AND UNTIL A NDA IS GRANTED. PEOPLE CONTINUE TO BE INJURED BY THIS MATERIAL. DENTISTS CONTINUE TO USE IT IN SECRECY -EVEN AFTER THE PT IS INJURED- BECAUSE THEY KNOW IT IS BELOW THE STANDARD OF CARE. THE FDA HAS THE JURISDICTION TO STOP THE MFG OF THIS MATERIAL AND SHOULD BE DOING SO. IN 1996, THE. IN 2007, THE FDA IS DOING NOTHING. WHAT HAS CHANGED BETWEEN 1996 AND TODAY THAT HAS MADE THIS DRUG NON-TOXIC AND ACCEPTABLE TO USE? IN 1991, THE FDA ISSUED A WARNING LETTER TO A COMPOUNDING PHARMACY FOR ILLEGALLY ACTING AS A MFG SELLING BULK QUANTITIES ACROSS STATE LINES. HTTP://WWW.CASEWATCH.ORG/FDAWARNING/COMP/SARGENTS.SHTML-. WHY IS IT THAT TODAY NO WARNING LETTERS ARE GENERATED YET THE FDA HAS AFFIRMED THAT THEIR POSITION HAS NOT CHANGED ON THIS MATERIAL SINCE 1991? IN SOME CASES, THE FDA CAN REGULATE DENTISTS FOR USE OF UNAPPROVED DRUGS/DEVICES/ETC. I REQUEST THAT THE FDA SUBMIT LETTERS TO EACH STATE DENTAL AND PHARMACY BOARD TO DEMAND THAT THE USE OF SARGENTI AND OTHER PARAFORMALDEHYDE CONTAINING DENTAL MATERIALS BE REMOVED FROM THE MARKET AND THE USE BE STOPPED. IT IS CLAIMED BY SARGENTI SUPPORTERS THAT US PHARMACIES ARE SELLING SARGENTI PASTE INTERNATIONALLY TO COUNTRIES. THEY RECENTLY TOUTED THAT THEY HAVE SUPPLIED 400 ROOT CANAL'S WORTH OF THIS MATERIAL FOR USE IN OTHER COUNTRY. IF INTERSTATE BULK SALES ARE NOT ALLOW, HOW ARE INTERNATIONAL SALES ALLOWED? DOSE OR AMOUNT: >3 CANALS, FREQUENCY: ONCE, ROUTE: DENTAL. DIAGNOSIS OR REASON FOR USE: TOOTH ACHE- #18-.