Monday, May 14, 2007

Doctors Frequently Asked Questions About DMPS

Q: Is it legal to prescribe DMPS?

A: It is considered like any other chemical you would order by prescription to be compounded for a patient.

Q: Is DMPS now FDA approved?

A. No. Its current status is as a bulk chemical that may be used in compounding. It is included on the FDA list of Bulk Chemicals That May Be Used In Pharmacy Compounding. Final approval of the list is still pending. The appearance of DMPS or any chemical on this list in no way should be construed as FDA approval. FDA approval generally infers that a drug has been subjected to clinical trials under an IND application to ascertain its safety and efficacy.

This has not been done in the US with DMPS as of this date. (To our knowledge, Heyl is the only DMPS manufacturer with an IND application on file with the FDA.) You may access additional information on the history and the chemicals under consideration through the internet address – http://www.fda.gov/cder/fdama/draft4.pdf

Q: Can DMPS be used orally?

A: Yes. Oral administration is common in other parts of the world. According to Heyl-Berlin, the leading manufacturer of DMPS, oral capsules are the preferred route of administration in chronic metal intoxication with IV administration being reserved for acute poisoning cases or in instances when oral dosing is not possible.

Q: IS DMPS used for conditions other than metal toxicity?

A. The Heyltex Scientific Monograph lists all the known experiments with DMPS in conditions other than metal toxicity on pages 69-71.

Q: Can I use DMPS with DMSA or other chelators?

A: Many physicians alternate use of DMPS with other chelators such as DMSA and EDTA. Heyl does not recommend this. DMPS should not be administered concomitantly with other chelating agents . NOTE: (The manufacturer’s of DMSA do not recommend mixing their chelating agent with any other chelator. DMSA information in the Physcian’s Desk Reference recommends a 4 week "rest" period after the last dose of DMSA before the initiation of any other chelator).
Q: Can you administer DMPS by the IV drip method?

A: DMPS is a dithiol chemical and as such it oxidizes fairly rapidly once in solution when exposed to ambient air. It also oxidizes rapidly at approximately a pH of 7 or greater, therefore IV drip method would probably not be the best route of administration. There is no scientific evidence that oxidized DMPS is of any value in any condition it may used for.

Q: Can I use DMPS as an admixture in a vitamin C IV formula?

A: Oxidation of DMPS is still of concern in this instance. Sodium bicarbonate is generally added to IV-C solutions to adjust the pH. This may cause oxidation, particularly if administered over the usual 2-3 hour time period for this type of IV. (Vitamin C is a reducing agent, it’s possible that it prevents the oxidation of DMPS but this has not been tested or documented. )

Q: What should I mix DMPS with?

A: Generally DMPS should not be mixed with any other chemical or solution. (ie; other chelating agents, normal saline or sodium bicarbonate). This may change the pH which will cause oxidation of the DMPS. A review of the scientific monograph will reveal that it was never mixed with any other solution.

Q: Does DMPS cross over the blood brain barrier?

A: Animal studies indicated that it does not cross over. It also did not carry metal into the brain of animals.

Q: Does DMPS dissolve amalgams in the teeth?

A: DMPS has been used in Germany for a number of years. There have been no reports of dissolved Amalgams.

Q: Is oral DMPS considered a nutritional?

A: Absolutely not. Under no circumstances should DMPS in any form be considered a nutritional product.

Q: Should everyone with suspected metal toxicity receive DMPS?

A: Not necessarily. Data from various researchers around the world indicate that some people spontaneously excrete toxic metals once the individual has been removed from exposure. In the prescribing of any drug or compound, a physician must consider the risk/benefit ratio and make a decision based upon the clinical and laboratory evidence at hand. Not everyone will benefit from the use of DMPS.

Q: Can DMPS be applied topically or as a suppository?

A: According to leading toxicologists and Heyl scientists, there is no benefit to administering DMPS either topically or rectally. There is no data on the absorption of DMPS by these routes of administration. Also of concern is the pH and air exposure of these preparations and the rate of oxidation of the DMPS. The preferred route of administration is oral.

Q: Can DMPS be given to children?

A: Yes. If children are not yet able to swallow capsules, the powder in the capsule can be mixed with cold orange juice (or some other acidic juice) for ingestion.

Q: What is the protocol for administering DMPS?

A: Heyl does not have their own protocol for administering DMPS. Treatment is left to the clinical judgement of the attending physician. Our monograph lists the various dosing protocols for mobilization of heavy metals by several researchers on pages 109-111. The literature describes IV injections of 3mg/kg BW with a maximum dose of 250mg given every four hours for 24-48 hours in severely poisoned individuals, with follow-up oral dosing for several days to several weeks. Acutely poisoned persons are usually hospitalized. Duration of treatment is determined by the continued monitoring of blood and urine samples for excretion of toxic metals. Each physician, who ascertains in their professional and clinical assessment that their patient would benefit from DMPS, must decide the best route to follow for the individual patient.

Q: If I specifically want a prescription I write for DMPS to be filled with the Heyl product, how can I be sure that this will be done?

A: When writing a prescription for any compound, a doctor may specify the manufacturer of the bulk chemical to be used. You may also want to request a copy of the Certificate of Analysis that is provided by the chemicals’ manufacturer.

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