FDA News & Adverse Event Reports

FDA News & Adverse Event Reports 

 

Reporting an Adverse Event with a Cosmetic Product

The US Food & Drug Administration (FDA) encourages patients and physicians to submit a report directly to the FDA in the case of a reaction or problem with a cosmetic product.  The FDA does not provide medical advice, rather the first step is to stop using the product and contact your healthcare provider. Then, report the problem to FDA. 

To report an adverse cosmetic product event go to: http://www.fda.gov/Cosmetics/ComplianceEnforcement/AdverseEventReporting/default.htm

Reporting other (cosmetic or non-cosmetic) adverse events to the FDA

 


July 19, 2016 - US Food & Drug Administration (FDA) Statement

Today the U.S. Food & Drug Administration (FDA) posted a statement on its investigation of WEN by Chaz Dean Cleansing Conditioners.  As of July 7, 2016, the FDA had received 127 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners.The FDA has not yet determined a possible cause for the adverse events that have been reported with these products, and has called on 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.” 

The agency is also urging both consumers and physicians/health care providers to report to the FDA any reactions that they or their patients have experienced while using these products.


February 29, 2016 - FDA takes additional action to better understand safety of Essure, inform patients of potential risks

The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.  Over the past 14 years, FDA has reviewed a significant amount of information related to the use of Essure. While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.

 

 

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