FDA: Balding, Rash Associated with Hair Cleanser

The FDA received 127 adverse event reports regarding the product
The FDA received 127 adverse event reports regarding the product

The Food and Drug Administration (FDA) is investigating cases of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products. 

From February 18, 2011 through July 7, 2016, the Agency received 127 adverse event reports regarding WEN by Chaz Dean Cleansing Conditioner products — the most hair-related reports ever associated with any cosmetic hair cleanser, including cleansing conditioners. Also, the FDA is investigating >21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC, that were brought to light during inspections of manufacturing and distribution facilities. 

A possible cause for the adverse events has not yet been determined. The FDA has requested the company to "provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products." 

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Physicians and other healthcare providers have been alerted to notify their patients of such complaints associated with the use of these products. If patients have experienced adverse events associated with WEN by Chaz Dean Cleansing Conditioner products, they are encouraged to report the event to the FDA, including the following, with an informed patient consent form, as appropriate:

  • A case description of the adverse events, including the specific cleansing conditioner products the patient used, how long he or she used the cleansing conditioner products, and how long he or she kept the product in his or her hair. (Specific product labeling would be helpful)
  • The autoimmune status of the patient
  • Relevant laboratory and biopsy results
  • Concomitant medication and cosmetic use

Users who experience a reaction following the use of WEN by Chaz Dean Cleansing Conditioner products should discontinue use and consult with their dermatologist or other healthcare provider.

The FDA will update the public as new data becomes available. 

For more information visit FDA.gov.

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