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Mercury in Medicine

While most people have heard that the mercury base preservative thimerosal was used in infant vaccines and continues to be used in several vaccine preparations including influenza, tetanus and meningococcal vaccines, most consumers have no idea that mercury is also a commonly used ingredient in other pharmaceutical products including nasal sprays, eye drops, ear drops and injectable testosterone.

There are several hundred peer-reviewed scientific publications published over the last 7 decades by leading research scientists, and public health agencies that have confirmed that thimerosal is a potent neurotoxin. It has never been proven safe for medical use and cost-effective alternatives exist.

There are, at last count, over 100 FDA-approved pharmaceutical products which contain mercury. The typical amount of mercury in these products is 50,000 ppb. To put this in perspective, the EPA requires liquid waste which exceeds 200 ppb of mercury to be sent to a special hazardous waste landfill and according to the EPA, drinking water cannot exceed 2 ppb of mercury. So, technically, if these products are not used, they must be disposed of as hazardous waste.

What makes the fact that mercury continues to be used in medical products even more disturbing is the fact that Food and Drug Administration (FDA) has recognized the inherent risks from the use of mercury in medicine since 1975 when they convened an expert panel to review its use in over the counter (OTC) products. The FDA published proposed rules in the Federal Register on January 5, 1982 that found mercury containing products were toxic, caused cell death, and in the case of thimerosal, were only as effective as water as a preservative. The panel members concluded that all mercury based preservatives used in over the counter products should be labeled as category II, “not being generally recognized as being safe or effective.”

Despite the expert panel’s recommendation, the FDA did not actually act on these recommendations until 1998. In the final rulemaking, the FDA stated that the safety and effectiveness have not been established for the ingredients (mercury based preservatives) included in this current final rule and manufacturers have not submitted the necessary data in response to earlier opportunities. The agency’s experience has been that under these circumstances companies have not submitted data in response to yet another opportunity. Consumers will benefit from the early removal from the marketplace of products containing ingredients for which safety and effectiveness has not been established.”

One might ask how is it possible that one division of the FDA recognizes that there is absolutely no safety or effectiveness data available for the use of mercury in over the counter products and essentially ban their use in over the counter products, while the FDA division of blood and biologics continues to allow their wide spread use in over 200 prescription products?

The FDA expert panel report from 1982 states “It has been the general course of events that, whenever a mercury compound has been tried for a particular therapeutic function, it has been used enthusiastically at first, only to be replaced by a safer or more effective drug.”

Robert Kennedy Jr. published a book, Thimerosal: Let the Science Speak which summarizes several hundred peer-reviewed scientific publications which confirm that thimerosal is a dangerous neurotoxin that has never been proven safe for use and for which cost-effective alternatives exist. It is beyond time for the use of mercury in medicine to finally end.

Because our federal health agencies have not kept pace with the science, it is up to the consumer to be knowledgeable about what products contain mercury and responsible for protecting themselves from this unnecessary risk. Be sure to read labels and read the report below regarding the use of mercury in drugs and biological products and the use of mercury in vaccines and be sure to avoid their use.

American Academy of Pediatrics – Technical Report: Mercury in the Environment: Implications for Pediatricians

In response to the Food and Drug Administration Modernization Act of 1997,1 the US Food and Drug Administration (FDA) has been reviewing the use of mercury in regulated biological products. In June 1999, the FDA notified the American Academy of Pediatrics that some infants given routine immunizations could exceed 1 of 3 federal guidelines for daily exposure to mercury because of the presence of thimerosal, a mercury-containing preservative, in some vaccines.2 Currently, all vaccines in the recommended vaccination schedule do not contain thimerosal as a preservative. This technical report provides additional information about the sources, exposures, and toxicity of the 3 forms of mercury in the environment and implications for pediatricians.

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Federal Register 4-22-98 Thimerosal not GRASE and misbranded

Summary: The Food and Drug Administration (FDA) is issuing an advance notice of a proposed rulemaking that would classify over-the-counter (OTC) mercury-containing drug products for topical antimicrobial use as not generally recognized as safe and effective and as being misbranded…

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1982 Federal Register Mercury in OTC products ANPR

Summary: The Food and Drug Administration (FDA) is issuing an advance notice of a proposed rulemaking that would classify over-the-counter (OTC) mercury-containing drug products for topical antimicrobial use as not generally recognized as safe and effective and as being misbranded…

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Mercury in Drug and Biologic Products

The information in this list is derived from submissions made by manufacturers+ in response to the agency’s call-for-data notices of December 14, 1998 (63 FR 68775), April 29, 1999 (64 FR 23083) and February 3, 2003 (68 FR 5299), the agency’s Drug Registration and Listing System, and other agency sources.

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