Simply Slim, sibutramine and synephrine

With tens of thousands of unregistered complementary medicines on the market, it’s interesting and surprising that the Medicines Control Council (MCC) recently ordered one product, Simply Slim, to suspend all sales and marketing until the MCC had had an opportunity to assess the product in terms of its safety, quality and efficacy. The decision was made at the very last Council meeting of the last incumbents on January 27 2010. A new Council has since been appointed. Perhaps we will see a few more of these products being scrutinised and not simply (sic) being made available to a largely uninformed public who are unaware of the pharmacological effects of a variety of active ingredients in these products.

Simply Slim certainly had a high profile and was widely advertised and marketed through a series of distributors. The initial advertising stated that the product would assist with weight loss without needing dietary changes or without exercise being necessary. This brought it foul of the Advertising Standards Authority and an ad-alert was issued against the company. The advertising was changed and the website subsequently included “wellness” information such as exercise programmes and eating plans.

A number of persons, however, were experiencing unusual side-effects after taking the product. This prompted a pharmacist to have the product independently tested — and the presence of sibutramine was found. Sibutramine was not listed as an ingredient of Simply Slim. Sibutramine is a Schedule 5 substance which means that it can only be made available on prescription from a medical doctor. The reason a doctor would prescribe sibutramine is because it has been proven to promote weight loss. It’s little wonder then that Simply Slim was so successful for many users. What the medical doctor prescribing sibutramine would know — and your average lay person distributor of Simply Slim would not know, is that there are contra-indications to the use of sibutramine. This is when the substance may not be used at all. These contra-indications include:

History of major eating disorders or psychotic illness; coronary artery disease, congestive cardiac failure, tachycardia, arrhythmias, uncontrolled hypertension, hyperthyroidism, prostatic hypertrophy, phaeochromocytoma, closed-angle glaucoma, epilepsy; history of drug or alcohol abuse; children under 18 years; porphyria. (South African Medicines Formulary)

A significant warning is that sibutramine should be avoided in combination with any substance likely to increase a person’s blood pressure. Synephrine is a constituent of “bitter orange” or “bigarade orange” (Citrus aurantium) which is listed as an ingredient of Simply Slim. Synephrine is likely to cause an increase in blood pressure and has been implicated in serious adverse reactions such as heart attack and stroke in Canada and elsewhere in the world. A case report was even reported in the South African Medical Journal in 2008 of a body builder who had a heart attack while using a combination of substances which included synephrine.

A combination of sibutramine and synephrine would probably make Simply Slim even more risky than when either substance is taken alone.

Department of health spokesperson Fidel Hadebe erroneously stated that synephrine is a Schedule 5 substance. This was unfortunately repeated in the Pharmaceutical Society of South Africa’s notice to its members concerning Simply Slim. A form of synephrine, meta-synephrine or m-synephrine, also known as phenylephrine is a Schedule 1 substance which does not require a prescription.

A number of weight loss products on the market contain synephrine and may well pose a risk to the public if persons with a predisposition to hypertension or other medical conditions take them. Consumers should check labels for bitter orange, Citrus aurantium or synephrine. Another name used for synephrine is oxedrine.

The sellers of Simply Slim have in the mean time announced that they are going to launch a new product. This sounds rather suspicious — but could also be interpreted as an admission that the previous product may well have been adulterated with sibutramine or had other shortcomings. We can only assume that the MCC will require evidence that the new version/product is safe, effective and of good quality before it will allow it to be registered as a medicine or made available to the public.

It is in the public’s best interest that the complementary medicines call-up notice should be rescinded. This misguided notice has enabled myriad products, including Simply Slim, to be marketed to unsuspecting consumers without any regulatory oversight and with no protection for the consumer. It was only after problems started surfacing that any action was taken against Simply Slim. A proactive rather than a retroactive, reactive system is urgently required — in fact this is the statutory duty of the MCC.

It would be interesting if any of those who were misled by Simply Slim could obtain recompense through the Consumer Protection Act and whether the apparently still-to-be-appointed National Consumer Commission would take action against the company and its directors and impose appropriately hefty fines. It could be a precedent-setting opportunity for the commission to establish its credibility and show that it is a body with teeth.