Saturday, May 12, 2012

Another DMAA horror story

It appears that the days of DMAA are numbered. The Food and Drug Administration (FDA) recently sent out a warning letter to several companies whose products contain DMAA. This was shortly followed by a rash of class action lawsuits filed against these same companies. Many of the companies have voluntarily removed DMAA from their products, but other companies, particularly one, still insists that DMAA is a natural substance that falls under the aegis of the DHSA law of 1994. This means that if it exists naturally in food, it's allowable in supplements.The entire basis for the natural source of DMAA stems from a single study published in a now defunct Chinese journal in 1996. That study found a content of 0.7% DMAA in a sample of geranium oil.They did not, however, perform a confirmatory test, which would have involved comparing the substance that they found in the geranium oil to an actual sample of DMAA. As such, the finding that DMAA exists naturally in germanium is open to question.
    But it isn't really. A number of analytical studies have examined various samples of geranium oil for the presence of DMAA, and none, not one, has ever detected the presence of DMAA in those samples. This has led to the notion that DMAA never actually existed in geranium oil, but was added to supplements. This is a problem, since DMAA is an old drug, originally used as a nasal decongestant. If it's added to supplements, that makes it illegal. Canada banned DMAA soon after the updated analytical tests were published. One of the companies that sells a DMAA product has countered the extensive criticism of  DMAA by sponsoring a series of studies to test for the safety of supplements containing DMAA in suggested doses. These studies show that other than a slight rise in blood pressure, DMAA appears to be safe when used as directed. But the death of two army recruits who allegedly suffered fatal strokes after using a DMAA supplement, renewed the attacks on DMAA, and led to the FDA action. In the meantime, the company that sponsored the safety studies of DMAA has announced that they have another study that will prove that DMAA is indeed found naturally in geranium oil. But they have not yet released the study.
     The real question is how safe is DMAA, and does it deserve to suffer the fate of previous supplements, such as ephedrine, which was wrongfully removed from market sales because of questionable safety concerns. Besides the deaths of the two soldiers, a number of adverse reports have been published related to the use of DMAA in New Zealand as a "party drug." One such report was of a user who suffered a stroke after ingesting DMAA. Other side effects have included panic attacks, seizures,and stress-induced cardiomyopathy. But these cases may have involved people who used larger doses than the suggested supplemental dose of DMAA. The case of the guy who had the stress-induced cardiomyopathy is a good example.
     This involved a 24-year-old man who showed up at a hospital emergency room soon after ingesting a popular bodybuilding supplement called "Jack3D" that contained DMAA and several other common bodybuilding ingredients, such as creatine, beta-alanine, and arginine. It also contained caffeine, which can have similar effects to that of DMAA. In fact, the strength of DMAA has been compared to what happens when you drink 3-4 cups of strong coffee.While the guy had a viral illness a month earlier, he also had no signs or history of cardiovascular disease. But when he arrived at the ER, his symptoms included a headache, heart palpitations,nausea, vomiting, and chest pain.He was also heavily sweating, with elevated heart rate and blood pressure.A chest X-ray showed signs of pulmonary edema, or fluid in the lungs. A urine test proved negative for cocaine usage. But his heart ejection fraction was below 20. Normal is 55 or above, and a low reading suggests heart failure.
      The official diagnosis was for Takotsubo cardiomyopathy, a form of heart failure. But a month after leaving the hospital, he showed a normal ejection fraction reading. It turned out that the man worked for a distributor of the company that sells Jack3D. He had customized his Jack3D supplement by adding more DMAA, 1.5 times more than was contained in the product. A report published in 1950 said that DMAA has a more potent level of toxicity than ephedrine, but less than amphetamine. The report, which was related to the use of DMAA in nasal decongestants, suggested that because of the frequent side effects associated with its use, products containing DMAA should be removed from the market, and that's just what the drug companies did--20 years later.
     So, is the FDA justified in its actions against DMAA? There have been 42 adverse reports sent to the FDA about DMAA. But the fact that DMAA is a drug, and is added to supplements under the guise that it's found naturally in geranium oil, does mean that its presence in over the counter supplements is a violation of the law, and that means that the FDA was correct in its decision about DMAA.


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