Cosmetics

Dear Health Care Provider Letter Regarding WEN by Chaz Dean Cleansing Conditioner and Adverse Reactions

FDA previously announced that it is conducting an investigation of adverse event reports for WEN by Chaz Dean Cleansing Conditioner products, including reports of hair loss, hair breakage, balding, itching and rash. FDA has received and continues to receive reports of adverse events, as the investigation is still ongoing. In the course of its investigations, the FDA is looking at all sources of information, in order to better understand the consumer reports of adverse events. There are many potential causes of hair loss, including, for example, certain illnesses, medications, hormonal changes, rapid weight loss or gain, anemia, and high-stress life events, and these factors are being taken into account as the FDA continues to investigate these reports. If you experience hair loss, you should contact your healthcare provider. As with any cosmetic product, if you experience an adverse event that you think may be related to use of WEN by Chaz Dean Cleansing Conditioner, you should also cease using the product and report the event to the FDA.

July 19, 2016

Dear Health Care Provider,

The U.S. Food and Drug Administration is currently investigating reports of hair loss, hair breakage, balding, itching, and rash reported to be associated with the use of WEN by Chaz Dean Cleansing Conditioners, manufactured and marketed by Chaz Dean, Inc. and Guthy Renker LLC, and we need your help to investigate these adverse  events further. Because cosmetic-related adverse events often result in skin irritation, allergic reactions, and hair loss, we believe that health care providers, particularly dermatologists, play a critical role in helping the FDA receive appropriate reports, including critical medical information and descriptions of findings.

From February 18, 2011 through July 7, 2016, the FDA has received 127 reports of adverse events associated with the use of WEN by Chaz Dean Cleansing Conditioners, which is the largest number of hair-related adverse events the FDA has ever received for any hair care product. Additionally, the FDA has become aware of more than 21,000 adverse event reports received by Chaz Dean, Inc. and Guthy Renker LLC. The FDA has not yet identified a cause for the reported adverse events. The FDA depends on physicians and other medical professionals to alert us to health issues they are seeing in their patients that may be related to cosmetic products, such as cleansing conditioners. Unlike drugs, cosmetics are not reviewed or approved by FDA before marketing, and the law does not require cosmetic manufacturers to provide to the FDA safety data on their products or to share adverse event reports that they receive.

Information Needed from Health Care Providers

The FDA is asking physicians with patients who have experienced adverse events after using WEN by Chaz Dean Cleansing Conditioner products to report the event to the agency, including the following information, with informed consent from the patient, 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.

Communication with Patients

We are asking for your help in communicating with your patients in the following ways:

  • Advise your patients about reported hair loss and other complaints reported to be associated with use of WEN by Chaz Dean Cleansing Conditioner products and share with them our FDA Statement and FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners, and
  • Encourage your patients who experience adverse events after using WEN by Chaz Dean Cleansing Conditioner products to report these events to the FDA.

We appreciate the extra time and effort it takes for health professionals to compile and submit such reports. This information is extremely valuable in helping us identify signals of potential safety issues, which can in turn help protect others from injury.

For additional information:

 

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