jueves, 24 de marzo de 2016

FDA MedWatch - Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning

AUDIENCE: Consumer
ISSUE: FDA is warning consumers not to use “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk. FDA laboratories have found elevated levels of lead in “Best Bentonite Clay.” Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.
BACKGROUND: “Best Bentonite Clay” is sold as a fine powder on Amazon.com and on the Best Bentonite website. According to the Best Bentonite website, customers mix the product with water and ingest it or apply it to their skin.
FDA has not confirmed any cases of lead poisoning associated with “Best Bentonite Clay.”
RECOMMENDATION: Consumers should not purchase or use “Best Bentonite Clay.” Anyone who has used this product or given it to a child should consult a health care professional immediately.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the FDA Alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm492157.htm

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