FDA’s advice on “Asset Bold”

Dr. P.Naina Mohamed

Pharmacologist

IntroductionOn 16th May 2014, the Food and Drug

Administration (FDA) is advising consumers

not to purchase or use “Asset Bold”.“Asset Bold” is promoted and sold for

weight loss and sold on various websites and in some retail stores.

 FDA laboratory analysis confirmed that “Asset Bold” contains Sibutramine.

Sibutramine is a controlled substance and it was removed from the market in October 2010 for safety reasons. 

Possible Mechanism of action

Risks of Asset Bold

Contraindications of Asset Bold (Sibutramine)

“Asset Bold” should not be used by the patient who has.. History of cerebrovascular disease (stroke or transient

ischemic attack) History of congestive heart failure History of coronary artery disease (eg, angina,

myocardial infarction) History of cardiac arrhythmias History of peripheral arterial occlusive disease Uncontrolled hypertension. Major eating disorders, major (eg, anorexia nervosa or

bulimia nervosa) Concomitant use with MAOIs Concomitant use with other centrally acting weight loss

drugs

Serious Drug Interactions

Interaction with Antidepressants

Interaction with NSAIDs

Interaction with Decongestants

Interaction with CYP3A4 Inhibitors

FDA Warnings• FDA warns the Consumers should stop using this

product immediately and throw it away.  • FDA advises the Consumers who have experienced

any negative side effects should consult a health care professional as soon as possible. 

• FDA announces to the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” 

• FDA claims that they are unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. 

• FDA advises the Consumers to exercise caution before purchasing any product in the above categories. 

FDA Warnings FDA has requested market withdrawal after reviewing data

from the Sibutramine Cardiovascular Outcomes Trial (SCOUT).

SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. 

The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo.

There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Sibutramine (Meridia) to their patients, and patients should stop taking this medication.

Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm228830.htm

Referenceshttp://www.fda.gov/Drugs/ResourcesForYou/C

onsumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm397704.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.micromedexsolutions.comCURRENT Diagnosis & Treatment:

Gastroenterology, Hepatology, & Endoscopy, 2eNorton J. Greenberger, Richard S. Blumberg, Robert Burakoff

Clinician's Pocket Reference, 11eLeonard G. Gomella, Steven A. Haist

Harrison's Online Featuring the complete contents of Harrison's Principles ofInternal Medicine, 18e

Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor

References

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm228830.htm

http://www.tga.gov.au/safety/alerts-medicine-sibutramine-101008.htm

http://www.medsafe.govt.nz/hot/media/2010/SibutramineOct2010.asp

http://www.bmj.com/content/340/bmj.c824