3/22/2016

Medication Health Fraud > Public Notification: Dynamizm Capsules contain hidden drug ingredient

U.S. Food and Drug Administration Protecting and Promoting Your Health

Public Notification: Dynamizm Capsules contain hidden drug ingredient [3­17­2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Dynamizm Capsules, a product promoted and sold for weight loss on various websites and possibly in some retail stores.    FDA laboratory analysis confirmed that Dynamizm Capsules contain sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life­threatening ways, with other medications a consumer may be taking.   Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/), or: Download and complete the form (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf), then submit it via fax at 1­800­FDA­0178.   Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemi cals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. 

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm491205.htm?source=govdelivery&utm_medi…

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3/22/2016

Medication Health Fraud > Public Notification: Dynamizm Capsules contain hidden drug ingredient

  For more information:   Tainted Weight Loss Product (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Medication HealthFraud/ucm234592.htm)   Subscribe to the RSS feed (http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml)   Beware of Fraudulent ‘Dietary Supplements’  (/ForConsumers/ConsumerUpdates/ucm246744.htm)  

Contact FDA Toll Free (855) 543­3784, or (301) 796­3400 [email protected] (mailto:[email protected]) Human Drug Information Division of Drug Information (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm082585) (CDER) Office of Communications Feedback Form (http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm) 10001 New Hampshire Avenue Hillandale Building, 4th Floor Silver Spring, MD 20993

Resources for You Sign Up for Email Alerts on Tainted Products Sold as Dietary Supplements (https://service.govdelivery.com/service/subscribe.html?code=USFDA_198)  Tainted Products That are Marketed as Dietary Supplements RSS Feed (http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml) 

More in Medication Health Fraud (/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/default.htm)

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm491205.htm?source=govdelivery&utm_medi…

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Medication Health Fraud _ Public Notification_ Dynamizm Capsules ...

(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf), then. submit it ... [email protected] (mailto:druginfo@fda.hhs.gov) ... (https://service.govdelivery.com/service/subscribe.html?code=USFDA_198).

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