FDA Alert: Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning – Undeclared Ingredients
This is a reprint of an FDA Alert
[Posted 07/26/2013]
AUDIENCE: Consumer, Health Professional
ISSUE: FDA is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.
BACKGROUND: The FDA has received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50. These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone.
RECOMMENDATION: Health care professionals are advised to ask their patients about any dietary supplements they may be using, particularly in patients exhibiting warning signs that may be associated with the use of steroids or steroid-like substances. These warning signs include liver injury, kidney failure and stroke. They also include hormone-associated adverse effects such as blood clots, including pulmonary embolism (a sudden blockage in a lung artery), and deep vein thrombosis (a blood clot that forms in a vein deep in the body, often in the lower leg or thigh). Consumers using Healthy Life Chemistry By Purity First B-50 who experience symptoms should consult a health care professional and report their experience to the FDA.
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.htm
- 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
[07/26/2013 Press Release – FDA]