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                Drug Safety and Availability

Drug Safety and Availability

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          FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite ClayDrug Safety and Availability FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay
  
  	
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    Printen EspañolLaboratory tests indicate elevated levels of leadThe U.S. Food and Drug Administration is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk.“Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a health care professional immediately.FDA laboratory analysis of the product found elevated lead levels.  Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.FDA learned that this product may contain lead from the Minnesota Department of Health.  FDA has not confirmed any cases of lead poisoning associated with the product.Health care professionals and consumers are encouraged to report any adverse events potentially related to “Bentonite Me Baby” by Alikay Naturals, or any other alternative medicines, to FDA’s MedWatch Adverse Event Reporting program by:Completing and submitting the report online at MedWatch Online Voluntary Reporting FormDownloading and completing the form, then submitting it via fax at 1-800-FDA-0178Bentonite ClayRelated InformationFDA Warns Consumers Not to Use âBest Bentonite Clayâ

                                                                                  Content current as of:
      03/23/2016Drug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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