The medicines, used for a wide range of conditions including slimming, asthma and arthritis, are derived from a botanical compound containing aristolochic acids
Dirty Dozen: 12 Supplements to Avoid Name(s) Dangers Regulatory Actions DEFINITELY HAZARDOUS: Documented organ failure or known carcinogenic properties Aristolochic acid
Potent human carcinogen; FDA warning to (Aristolochia, kidney failure, sometimes consumers and industry birthwort, requiring transplant; deaths and import alert in snakeroot, reported.
It was concluded that one of the botanicals (Stephania tetrandra) had been inadvertently substituted with Aristolochia fangchi (a botanical known to contain aristolochic acid
), because of the close similarity in the Chinese names.
There is no established safe exposure level to aristolochic acids
, which have been linked to kidney problems and urinary tract cancers.
The calibration curves were constructed for each aristolochic acid
by plotting the peak area versus concentration of each standard.
Pei, "NMR-based metabonomic study on the subacute toxicity of aristolochic acid
in rats," Food and Chemical Toxicology, vol.
The epidemiology, diagnosis, and management of aristolochic acid
nephropathy: A narrative review.
But the genome-wide spectrum of mutations associated with aristolochic acid
exposure remained largely unknown.
Traces of aristolochic acid
, a chemical often found in Chinese herbal remedies, were also found.
As a result of the ban on ephedra, there has also been speculation that FDA, when finished with ephedra, will pursue other dietary ingredients being used in weight loss products as "ephedra substitutes." At the FDA press conference announcing the impending ephedra ban, Commissioner McClellan commented, "It will definitely be something we'll be watching." Later, at the University of Mississippi presentation, he singled out bitter orange (citrus aurantium), aristolochic acid
and usinic acid as ingredients, which FDA would more closely examine in the near future.
He indicated that some of the supplements that the agency will closely examine include bitter orange, aristolochic acid
and usnic acid, all three of which, he asserted, can cause kidney damage and liver toxicity.
Closer analysis showed evidence of cancer cells in the pelvic area around the kidneys, and genetic material isolated from the tissue indicated the presence of aristolochic acid
. Both kidneys and ureters had to be removed.