  |
Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients
AUDIENCE: Consumer, Health Professional
ISSUE: The FDA is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness. The product’s ingredients are undergoing further analysis by the FDA. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances. In general, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.
BACKGROUND: The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet. An investigation is underway to identify the product’s manufacturer.
RECOMMENDATION: Consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine, or any other unexplained changes in their health. 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
Read the MedWatch safety alert, including links to the News Release and FDA Flickr at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm379740.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
