Sargenti paste cannot be sold at traditional dental supply stores since it is not approved by the FDA. No US drug manufacturer is allowed to make it nor is any overseas company allow to export it into the US because of its rejection by the FDA in 1993 (search "sargenti"). Small compounding pharmacies are often recruited by Sargenti proponents to sell only to members of their organization, the American Endodontic Society (AES). Because of inept practices and work overload at the FDA, these small pharmacies often escape the accountability that is needed to keep dental patients safe. We believe that these pharmacies are not completely aware of their violation of FDA rules and regulations because of the false information given to them by sargenti proponents.
In a recent seminar, a major sargenti proponent stated that 30,000 dentists in the US use sargenti paste, known because of information provided to them by their recruited pharmacies. Later in the discussion, it was revealed that there are a total of four pharmacies that sell it with one being in Canada and therefore can not legally sell into the US. In 2006, a founding member of our organization sued one of the three US pharmacies. From discovery, a complete list of dentist customers was provided for the previous 4 years. There were only 164 dentist customers, leaving 29,836 customers for the other 3 pharmacies, including the Canadian one which is not allow to sell into the USA. A very unlikely scenario. This application of factual data against their word again substantiates our claim of their chronic misrepresentation of the facts surrounding sargenti paste.
Information related to compounding pharmacies that manufacture and sell Sargenti Paste are posted below. We know that there are many more lawsuits against pharmacies that we have not been able uncover details.
April 2010 - Sargenti Selling Pharmacies Take Note - Don't Put a Target on Your Back, Jack H. Raber, Pharm.D. This article is written about he pharmacy involved in the "2004 -Seriously injured Sargenti Patient" information below.
2006 - FDA certifies no change in position on sale of Sargenti Paste since 1991 Commissioner Dr. David Kessler's letter (below)
2004 - Seriously injured Sargenti Patient sues a California compounding pharmacy that, against FDA regulation, supplied sargenti paste (RC2B - with the heavy metals) to the offending dentists. The case was settled for $40,000.
1996 - FDA confiscates and destroys another paraformaldehyde root canal paste similar to Sargenti Paste. It was disposed of as toxic waste.
mid-1990's - Injured Tuscaloosa, AL patient sues Tennessee compounding pharmacy in Federal Court, Birmingham, for the illegal sale of Sargenti Paste into Alabama. Pharmacy immediately initiated a settlement for an undisclosed amount.
1991 - FDA Commissioner, Dr. David Kessler, defines rules for compounding pharmacies that sell Sargenti Paste. The bottom line of this letter is that they are pushing the enforcement responsibility to the state pharmacy boards unless the pharmacy is acting as a manufacturer. The FDA has full authority over manufacturers. Compounding pharmacies are generally overseen by each State Pharmacy Board.
1991 - Warning letter to Glenn S. Balas, RPh, July 12, 1991 for illegal sale of Sargenti Paste compound across state lines. Dr. Balas was compounding this material in the basement of a Chicago hotel.
1980's - Pharmacy narrowly escapes legal action because of seriously injured patient's attorney's negligent handling of case from www.dentalaw.com
Manufacturer's escape from liability for toxic Sargenti paste blamed on legal malpractice of plaintiff's former counsel; successor counsel settles with dentist for $1,000,000.00; attorney defendant settles legal malpractice action for another $437,500.00
The drug was manufactured by Benito Ciccione, a New York pharmacist operating as Elbee Chemists, and was distributed throughout the United States by Ciccione's marketing company, Available Products, Inc. Co-counsel for plaintiff, Edwin J. Zinman, had previously obtained a jury verdict against these entities, including punitive damages, on the same issues in a San Francisco, California case.