[Amanda]

Quote

Media Statement
05 February 2010

MEDICINES CONTROL COUNCIL RECOMMENDS SUSPENSION OF THESALE OF THE MEDICINE: SIMPLY SLIM


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.

Mrs 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.”

For more information please contact Fidel Hadebe on
Issued by the Department of Health.

Ends

[Dee]

I still see them on sale at health shops and pamphlets being given out at traffic lights. It's so scary.

[Clarisse]

OMW, this is nuts hey! Its completely exploded now.

And there is a Simply slim SHOP in centurion mall. wonder if they are going to close doors.

[Elaine]

Especially for shirl!!! TOLD YOU SO!!!!!!!..............runs

[Annelie]

LOL! I am running out to buy more stock before its banned :p

[Noodle]

Ditto Annelie!!!!!! Better get some more today still!!

[Mick]

Annelie & Noodle - Given everything you've just read, your still willing to take something that dangerous? Thrill seekers are you?

[Lelanie]

Are you ladies serious about buying more? :huh:

See we posted at the same time Mick with the same kinda thought :nea:

[1stMom]

Very very scarey stuff, and to think I thought of trying it TG i didnt !!!!

[Annelie]

Mick, on 05 February 2010 - 02:45 PM, said:

Annelie & Noodle - Given everything you've just read, your still willing to take something that dangerous? Thrill seekers are you?

YES i am serious, have been taking it since last year with no side effects, EVERY single product on the market has side effects :p

[Mick]

Yea sure, every product does, I agree with you. However this is the first product in a long time where I've heard of so many people getting ill from. *shrugs* each to their own I guess.

[Lelanie]

Mick, on 05 February 2010 - 04:45 PM, said:

Yea sure, every product does, I agree with you. However this is the first product in a long time where I've heard of so many people getting ill from. *shrugs* each to their own I guess.

+1

You might not have any side effects now, but who's to say it won't catch up with you in a year, or 3 or 5?

[JessV]

This is flippen scary.

I took SS for 4 days, and then stopped, it was so awful. I felt like i was on a trip, and had awful palpitations, shivers and insomnia.

So glad they've taken it off the shelves, alltho i'm sorry for all the ppl who have invested time and money in this.

Have a look at these links:
http://www.iol.co.za...51344196C873430
http://www.newstoday...the-market.html

Seriously scary about the sibutramine ingredient being almost double the legal amount!

I agree with Lelanie... those of u that don't have any side effects now - u don't know what those ingredients are actually doing to your body... increased risk of stroke and heart attack - that's scary!

[Madoosa]

this is so scary! I'm glad i don't buy into any quick slimming products. It just proves again and again that the best solutions are the natural and regular ways to loose weight. The products themselves are dangerous indeed.

Flip. The thought of all those people still buying it makes me get chills.

[Gecko]

humph!

What a pity! I was actually thinking about trying it out.. (I hate taking any form of meds) TG I dont have money :p :LMAO:

[Courtney]

Err, ok, so you may die, but at least you'll be thin.

[Madoosa]

Courtney, on 05 February 2010 - 08:15 PM, said:

Err, ok, so you may die, but at least you'll be thin.

*giggles*

[ruby_jayne2006]

Simply Slim diet pill recalled
2010-02-05 22:50

Johannesburg -The diet pill Simply Slim was recalled with immediate effect for safety reasons, the health department said on Friday.

"The Medicines Control Council suspended sales of the product," health spokesperson Fidel Radebe said.

"It must be removed from shelves with immediate effect."

Radebe said the product should have been registered with the MCC and it was not.

"People have been complaining about difficulties during and after using this product. It can be dangerous to use," he said.

Beeld reported on Friday that the slimming product, which claims to be 100% herbal, contained sibutramine.

According to health regulations, any pill containing sibutramine must be registered as a prescription medicine and must contain no more than 15mg sibutramine.

Beeld, quoting Dr George van der Watt, a chemical pathologist at a Cape laboratory, said tests showed Simply Slim contained 27mg of sibutramine.

Simply Slim has maintained that these are falsified Simply Slim products.

Simply Slim is sold by agents who buy the product for about R350 and resell it for about R590, Beeld reported.

Side effects of sibutramine could include an increased risk of heart attacks and strokes.



- SAPA

[Annelie]

Ok, not going to get technical on this, and i agree that you guys have your opinions and that it "could" be dangerous, each to their own then.

[Lizelle]

I think the SS is the reason for me being in hospital this week..
Even though I stopped takingh them when I found out I was pg, I somehow think they're part of my kidney problems now :(