Slimming Capsules Contain Undeclared Drug Ingredient

The U.S. Food and Drug Administration (FDA) issued a warning that Slim Forte Slimming Capsules, Slim Forte Slimming Coffee and Botanical Slimming Soft Gel contain the undeclared drug ingredient sibutramine. Sibutramine was recalled from the U.S. market in October 2010 due to safety concerns.

These products are currently being sold and distributed through several websites managed by InterCharm, Inc.

According to the statement issued by the FDA, the undeclared ingredient in these products, sibutramine, is known to significantly increase blood pressure and pulse rate, and may cause serious complications for patients with a history of coronary artery disease and other conditions. Life-threatening interactions with other medications are also possible.

The FDA advised consumers to dispose of these products immediately and to report any side effects to their healthcare professionals.

For more information about FDA recalls, please visit Natural Standard's News database.

Comments

[JL]

I think KJodoin made an important point about looking for validation seals from third party testers as an additional standard that we as consumers may want to incorporate into our buying strategy once thorough research of the product/ingredients is complete and satisfactory. Unfortunately, given the vast number of products that may lack such additional testing, vigilance in monitoring the news and http://www.fda.gov/Safety/Recalls/default.htm for recalls is crucial. I know from personal experience how difficult it can be for a person to recognize when a weight loss strategy needs to be implemented to protect their health and benefit overall wellness, so I want to commend those who take steps to achieve their goal. Supplements may be considered for additional benefit, but as “tms” mentioned, a change in lifestyle and diet is nearly always the answer for healthy weight loss. This article really tells me we need to put as much effort into checking up on the safety of products we are using as we put into our initial research of the product.

[KJodoin]

I agree with EH's comment that consumers need to shoulder more responsibility by researching and understanding the ingredients contained within supplements they consume. However, with cases such as Slim Forte Slimming Capsules, it’s not the consumer who is lacking this responsibility- it’s the manufacturer. No amount of personal research could have told a consumer that sibutramine was in this product; it’s the manufacturer’s duty to list all ingredients. However, under the 1994 Dietary Supplements and Health Education Act (DSHEA), manufacturers are not held accountable to much of anything before marketing a product. They instead face retribution after the product has been marketed if the FDA gets around to proving that the product is false/misleading/unsafe. The FDA simply does not have the resources to regulate the booming industry of dietary supplements and unfortunately, as a result, consumers cannot guarantee that their product is safe or effective before use. The best option is to look for products that have validation seals from third party testers such as ConsumerLab and USP. These companies attest to the purity and standardization of a product by testing its ingredients in a laboratory setting.

[tms]

It’s the death of yet another miracle diet pill. It seems every other supplement out there is related to some sort of weight loss use. Unfortunately the FDA can’t help those who have already taken the capsules and can’t remove all the capsules directly from shelves. Thus it issues warnings like this, which we hope will reach most consumers. Once in a while, everyone needs to be reminded that as of yet, there’s no such thing as a miracle diet. The best bet may be a balanced diet with balanced active lifestyle. Natural Standard has a lot of information on eating healthy and active lifestyle in the “Foods, Herbs, & Supplements” database and also the “Health &Wellness” section.

[GW]

I do agree with what Jenna is saying however I believe the weight-loss supplement Phen-Fen (works as a serotonin agonist) was taken off the market due to it causing heart valve damage. Research was done to show that the increased serotonin levels directly caused valve damage leading to cardiovascular issues: http://www.sciencedirect.com/science/article/pii/S016372581100074X

[RS]

In response to Jenna, Gina, and Mr. Ward the article Mr. Ward referenced does say sibutramine is a combined norepinephrine and seretonin reuptake inhibitor. The authors agree this mechanism of action is the reason for increased heart rate and blood pressure as would be expected.

[Jenna Rhoades]

In response to M. Ward's explanation of increased danger resulting from sibutramine over phentermine, why would the forced reuptake of serotonin be dangerous to the heart? I can understand why the increased release of norepinephrine would be, as a vasopressor...but serotonin is not a neurotransmitter that I associate with cardiovascular complications nearly as much as I do norepinephrine.
High levels of serotonin can cause palpitations and arrhythmia, but if the serotonin is undergoing increased reuptake at, or being 'forced' back into, the presynaptic nerve terminal, then there should be less serotonin around to exert an effect. So basically, this would be the opposite of what is seen in serotonin syndrome and there should be less cardiac toxicity. At least, from what I understand...

[GW]

M.Ward, did u mean to say that sibutramine is a neurotransmitter reuptake inhibitor? Sibutramine inhibits the reuptake of serotonin, norepinephrine, and dopamine in the brain to trick the body into feeling full. Phentermine mostly releases norepinephrine.
Based on my research, the reason why sibutramine could be more dangerous than other anorexients could be due to a more potent inhibition of serotonin and norepinehprine reuptake as well as rapid absorption. However, there does not seem to be a clear reason.

[EH]

I'm concerned that the message isn't getting out there enough. The FDA recalled the product, but it appears that online vendors are still selling it. I think we need to look for new ways to get this information to consumers.

[AC]

It is rediculous that a company would put such a harmful substance in their products. This is a perfect example of why people need to research and review and supplement they consider consuming, especially since some can have horrible interactions with their current medication(s).

[PCT]

SIbutramine was not only banned by the FDA in the United States, but was recommended for removal from European Union markets as well as Iceland and Norway by the European Medicines Agency (EMA). The Irish Medicines Board will no longer authorize marketing of sibutramine containing products, and has recalled them from pharmacy shelves. If the European markets have decided the “benefits do not outweigh the risk” for this medication, I find that much more indicative of the dangers of this drug than the FDA ban, since the European market still allows many substances to be sold that are not allowed here in the United States. The fact that it is showing up in weight loss supplements sold on the internet is very troublesome. This is just one more indication that people should not be purchasing alternative medications or supplements online.

[M. Ward]

In response to RS, I read that sibutramine forces reuptake of the neurotransmitter serotonin, while phentermine's primary action is on the release of norepinephrine. In a longitudinal study of 10,742 over-weight or obese individuals, participants taking sibutramine supplements had an increased incidence of cardiac problems, as compared to those taking a placebo. You can read more about the study at http://www.ncbi.nlm.nih.gov/pubmed/20860415

[MKT]

This issue with Slim Forte slimming capsules demonstrates that consumers have access to unsafe supplements. Several individuals do not realize that supplements are not strictly monitored by the law like drugs are. Unfortunately, severe side effects or medical problems have to first occur in order for a product to be considered harmful. It is important for individuals to take caution and gather information when considering supplement usage.

[RS]

People who have been taking these products should throw them away immediately, if they haven’t already. And for patients experiencing negative side effects from Slim Forte slimming capsules should contact their PCP immediately. For anyone who has experienced adverse events or side effects related to this product, or has patients who have, you can help the FDA by reporting them to the MedWatch Safety Information and Adverse Event Reporting Program: professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm

[KZ]

That is a very discomforting thought that an ingredient like that is still on the market even after it has been banned. If you look up sibutramine online, it says that it is an anorexiant, similar to phentermine. I have read that phentermine has been known to increase the likelihood of cardiac events such as heart attack and stroke, the same as sibutramine. Does anyone know what makes sibutramine so much more dangerous than many of the oral anorexiants that are still on the market today?

[GW]

Is there a rule in place that the FDA can sue or heavily fine a company for knowingly having an ingredient contained in their product that was taken off the market because of safety issues? It really concerns me that all these companies have no interest in the safety of their customers. I wish the general public would be more cautious about these weight-loss supplements and would know not to use a product if they have little knowledge of what is actually in it.