FDA's warning against B-Perfect

FDA’s warning FDA’s warning againstagainst

““B-PerfectB-Perfect” ”

Dr. P.Naina MohamedPharmacologist

IntroductionIntroductionOn 05th June 2014, the Food and Drug Administration (FDA)

is advising consumers not to purchase or use “B-Perfect”.B-Perfect is a product promoted and sold for weight loss

on www.icanb-perfect.com and possibly sold in some retail stores.

FDA laboratory analysis confirmed that B-Perfect contains Sibutramine and Phenolphthalein.

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

Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.

Possible Possible Mechanism of Mechanism of

actionaction

RisksRisks of of Slim Trim USlim Trim U

ContraindicationsContraindications of of B-B-

Perfect Perfect (Sibutramine)(Sibutramine)• B-Perfect should not be used by the patient who has..

History of cerebrovascular disease (stroke or transient ischemic attack)

History of congestive heart failureHistory of coronary artery disease (eg, angina, myocardial

infarction)History of cardiac arrhythmiasHistory of peripheral arterial occlusive diseaseUncontrolled hypertension.Major eating disorders, major (eg, anorexia nervosa or

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

drugs

SeriousSerious Drug Drug InteractionsInteractions

Interaction with Interaction with

AntidepressantsAntidepressants

Interaction with Interaction with NSAIDsNSAIDs

Interaction with Interaction with

DecongestantsDecongestants

Interaction with Interaction with CYP3A4 CYP3A4

Inhibitors Inhibitors

FDA WarningsFDA 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 WarningsFDA 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

ReferencesReferenceshttp://www.fda.gov/Drugs/ResourcesForYou/

Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm399935.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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ReferencesReferences

• http://www.micromedexsolutions.com• 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