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Simply Slim

A great deal has been written in the press regarding Simply Slim.

Carte Blanche Consumer flighted on a Thursday gave an overview of the problems experienced with the product. As you the reader may now, a Scheduled substance, sibutramine, was found in the product.

These are the owners/directors of Simply Slim as featured in the program.

Simply Slim made a number of claims in a big media advert following the expose that the product contained sibutramine. Among other false claims, they stated that the amount of synephrine from bitter orange (Citrus aurantium), was the same amount as found in orange marmalade. What nonsense!

The Citrus aurantium used in weight-loss products is concentrated extract of the original plant.

Synephrine Levels Bitter Orange Materials

Material mg % mg/100 g
Fresh fruit 270 mg 0.020
Dried fruit 380 0.352
Dried extract 3000 3.003 – 3.079
Products 250-2500 0.250 – 0.989

 

 Source: Pellati F, Benvenuti S, Melegari M, Firenzuoli F. Determination of adrenergic agonists from extracts and herbal products of Citrus aurantium L. var. amara by LC. J Pharm Biomed Anal. 2002 Aug 1;29(6):1113-9.

So you can see, it may be low in the fresh product, but the fresh product is never used – a concentrate is used which gives high levels in capsules. It is NOT found in pineapple juice, but may be in the citrus variety "orange-pineapple".

And is this ingredient safe? Not at all!

The WHO Pharmaceuticals Newsletter No. 3, 2007 (http://www.who.int/medicines/publications/newsletter/PN_3_2007.pdf) carried the following report:

Citrus auranthium (sic) (bitter orange)

Reports of adverse cardiovascular effects Canada. Between 1 March 2004 and 31 October 2006, Health Canada received 21 domestic reports of adverse reactions suspected of being associated with Citrus auranthium (bitter orange). Of these, 15 reports were of cardiovascular adverse reactions, 10 of which were serious and included one report of myocardial infarction. According to Health Canada, synephrine, an alpha-adrenoceptor agonist found in bitter orange, can have serious adverse effects on heart rate and blood pressure; these effects are significantly potentiated by caffeine. Synephrine is found in various natural health products that are promoted for weight loss. Health Canada cautions that the following people may be particularly at risk of adverse reactions from synephrine containing products: those with heart conditions, Central Nervous System (CNS) disorders, diabetes mellitus, enlarged prostate, glaucoma, hypertension, phaeochromocytoma, thyroid disease or known risk factors for cardiovascular disease; those receiving caffeine containing products, monaoamine oxidase inhibitors, thyroid hormones or medications to control blood pressure or heart rate; underweight people.

Reference: Canadian Adverse Reactions Newsletter, Vol. 17(2): 2, April 2007 (www.hc-sc.gc.ca).

And see: http://hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v17n2_e.html for original.

 

Medicines Control Council recommends suspension of the sale of the medicine

"It has come to the attention of the Medicines Control Council that the weight loss product SIMPLY SLIM may pose significant risks to the South
African public. For this reason the Medicines Control Council (MCC) resolved to immediately suspend the sale of SIMPLY SLIM weight loss products in the country until further investigations and review can be completed. This decision was made during its meeting on 27 January 2010.

SIMPLY SLIM is a weight loss product that is not registered as a medicine by the MCC as it is being promoted and sold as a complementary herbal weight loss product. It is being sold at various retail outlets including health shops and pharmacies and is being actively marketed to consumers as a weight loss product.

After careful review of available evidence the Council concluded that the
risks associated with the use of weight loss medicine SIMPLY SLIM are greater than the benefits and that the product needs to be registered
as a medicine before it can continue to be sold. Council based its decision on the outcome of an investigation it conducted on the product SIMPLY SLIM.

Samples of the product were collected from various suppliers and tested at reputable laboratories. The testing of certain batches revealed that
the product contained sibutramine, which is the active ingredient of some Schedule 5 weight loss medicines registered in terms of the Medicines and Related Substances Act, 1965. In addition, the active ingredient of SIMPLY SLIM is bitter orange, the principal active chemical ingredient of which is synephrine, which is also a Schedule 5 substance. Medicines containing Schedule 5 substances must be registered as medicines and may only be sold on a prescription from a doctor and used in patients under the personal supervision of the doctor.

Sibutramine is not listed among ingredients reflected on the product packaging of SIMPLY SLIM and is associated with significant adverse effects
including heart problems. In addition, Council has received a number of product complaints from members of the public. These complaints ranged from patients experiencing nausea, headaches, psychological effects and cardiovascular events.

Based on these findings, the MCC resolved to suspend the sale of SIMPLY SLIM until more complete supportive data on the safety, quality and efficacy of the medicine has been submitted by the manufacturer and evaluated by the Council. Only if the MCC is completely satisfied that the medicine is safe, effective, of good quality and therefore in the public interest will it allow the product to be registered and sold in South Africa.

Mandisa Hela, Registrar of Medicines, reminded the public that "the Medicines Control Council is the statutory body ultimately responsible for ensuring that all medicines and medicinal products available on the South African market are safe, effective and of good quality and that their
availability should be in the interest of the public." 
 

 

 

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