FDA: Weight Loss Supplement Contains Undeclared Drug

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for the weight loss supplement Slimdia Revolution.

The FDA found traces of sibutramine in the supplement. Sibutramine is an appetite suppressant drug that was withdrawn from the market in 2010. Thus, Slimdia Revolution is considered an unapproved drug. The manufacturer P&J Trading has voluntarily recalled all Slimdia Revolution products.

In November 2012, the FDA also found sibutramine in three other weight loss supplements: Japan Hokkaido Slimming Weight Loss Pills, Beautiful Slim Body and Best Share Green Coffee: Brazilian Slimming Coffee.

Sibutramine can raise blood pressure and heart rate, causing potential complications in individuals with heart disease, heart failure, arrhythmias or stroke. Sibutramine may also interact adversely with prescription drugs.

P&J Trading is offering customers in possession of Slimdia Revolution a full refund for the unused product.

Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information on integrative therapies for weight loss, please visit Natural Standard's Comparative Effectiveness Database.

Comments

[SB]

I think that somebody needs to impose stricter penalties on the companies doing this sort of thing, because we keep seeing the same story time and again. If there were criminal charges or huge fines associated with it, maybe they would be less likly to break the rules.

[SS]

It is articles like this that make me even more hesitant about weight loss supplements. My mother has tried a few over the years and I am always discussing with her the side effects and the concerns with these products. It is scary to think that supplements that you think you know the ingredients in could have something else as well that could be harmful to your health. In my opinion I always tell people to just try diet and exercise first.

[ML]

I am surprised that this weight loss drug was able to be on the shelves. I wonder how long it has been available. A lot of the weight loss drugs have ingredients that increase heart rate, which may be an issue for people with underlying heart conditions. I am glad that the FDA was able to figure this out before anything serious happened to anyone. There are options that are FDA approved for weight loss available over the counter, such as orlistat (Xenical).

[bc]

I agree that many consumers automatically assume that over the counter products are safe. I agree that there needs to be more regulations over the counter. Prior to starting new therapy, whether it is over the counter, should be discussed with a health care provider.

[Nathan]

Well, it is quite true that supplements come with various declared and undeclared drugs. It is not always true that only undeclared drugs are available there in these supplements. There are various well known brands producing several supplements and those supplements are liked and used a lot throughout the world as well. Now the things to stay away from unwanted side effects and negative effects is to do a complete homework or research of the product before buying that. It will allow buying right product from right producer. I am sharing one of the very well known supplement manufacturer here.
http://usplabsdirect.com/OxyELITE-Pro

[kl]

In my opinion, pharmacists have a responsibility to educate patients about their natural medicine selection. A great tool for pharmacists to utilize in this process is the Natural Standard Products Studied Tool. This feature of the database reports brand names used in clinical trails, brands of natural medicines studied by third-party testers such as Consumer Lab, Consumer Reports, Natural Products Association, NSF International, and USP, as well as current US patents. Herbs and supplements that have been verified by these third party testers should be recommended over products that have not been tested.

[BC]

I believe it is vital for consumers to understand the ingredients that are in weight loss supplements prior to consumption. It is crucial that supplemental medications are also given the same attention as prescription drugs because of the potential side effects and interactions. Consumers have the ability to inquire with their healthcare provider especially in the retail setting at the local pharmacy to ask personalized questions based on their health condition. In the same way, it is important for healthcare professionals to continue in education on supplemental medications and what type of effect it has in certain health conditions. Articles like this raises awareness and stirs attention to tighter regulation on OTC products.

[SC]

I agree that is extremely important to discuss medications you want to start with a healthcare provider before you start taking it. If your healthcare provider does not know about the specific product, they have the resources to access reliable information about the product and can inform you of the risks of the medications in conjunction with your other medications, or the side effects of the medication. It is important for the public to know that the FDA does not regulate dietary products and ingredients the same way they do prescription and OTC drugs. The manufacturer of the dietary supplement or ingredient is responsible for ensuring the safety before it is marketed. It is only after it is on the market that the FDA is responsible for removing it if it is unsafe.

[MN]

Many consumers think that if it’s over the counter products then it would be safe. It is scary to think that companies like P&J trading might put dangerous unapproved substance in their products. This incident is an indication for the need of more regulations for over the counter products.

[af]

In my opinion, losing weight should only be accomplished through diet and exercise. Because sibutramine is a stimulant with euphoric effects on the brain, it has the potential to cause addiction and is therefore a controlled substance like other CNS stimulants, including Adderall. I do not think doctors should be prescribing medications that have effects on the brain and that may negatively affect the heart and exacerbate heart conditions to individuals who do not have medical conditions like ADD or ADHD. Weight loss should be achieved through lifestyle modifications and not by resorting to potentially dangerous drugs like stimulants.

[aw]

I agree with JS in that it is important for the patient to take charge of their healthcare and ask a doctor or pharmacist about supplement usage before taking a new OTC product. However, I wonder whether the doctor or pharmacist would have been aware that sibutramine was in the products in question. It seems as if it was not listed on the label, which would have made it more difficult for a doctor or pharmacist to verify the appropriateness of this treatment. Perhaps there should be some sort of testing to natural products before they hit the US market; this seems to be the only way to prevent this sort of problem from occurring in the first place.

[NL]

I completely agree with the concern that many purchase diet pills online without understanding the concerns and warnings. Articles like this raise some awareness but there should be more.

[af]

I think this is a great reason for why we need to be advocates for our own health. It is so important to read drug labels to find out what exactly a dietary supplement is made of and to know what the components of such supplements are, what their side effects are, which drugs they interact with, etc. Healthcare professionals who have been educated about herbs and supplements have a great advantage if they have learned about topics and natural products that are listed and discussed on Natural Standard’s databases. As a future pharmacist, I am glad that I have been involved with the Natural Standard research collaboration for this reason.

[JS]

In my opinion, this article demonstrates the importance of clinicians being knowledgeable about natural products and how they are regulated. If a patient asks about a new OTC diet drug, I think it’s important for the pharmacist to let the patient know that dietary supplements do not have to be FDA approved before they are put on the market. However, the FDA may pull the product off the market after it is released to the consumer if there are safety concerns. It’s also important for the clinician or pharmacist to stress the importance of the patient checking with their doctor or pharmacist before taking a dietary supplement especially if the patient is pregnant or they’re taking prescription medications.

[JH]

This should be a red flag to those who want to lose weight fast without dieting and exercise. Even those people who took sibutramine didn't see much change in their weight.
Sibutramine Cardiovascular Outcomes Trial (SCOUT) was 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.

[tx]

It is amazing that with all of the regulations available for prescription medications, that supplements like this can just sneak by under the FDA's nose. It seems naive to believe that the manufacturer P&J Trading was unaware of the presence of sibutramine in their product. I wonder how long Slimdia Revolution was on the market before this discovery was made, and how many patients were adversely affected by this unapproved drug product. I also wonder what needs to be done to prevent this from happening again; more regulation is clearly needed, but overregulation can make it difficult for products that are not dangerous to become more available as well.

[MS]

During a 3.4 year study of the effect of sibutramine on cardiovascular outcomes in overweight and obese subjects, increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause was seen(http://www.ncbi.nlm.nih.gov/pubmed/20818901). Since many times individuals purchase diet pills online it is necessary that public announcements are made regarding the dangers of various products.