« Natural Standard en Français | Main | MHRA: Echinacea May Be Unsafe for Children »

August 22, 2012

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a00d8341c7bb653ef01761761c9cc970c

Listed below are links to weblogs that reference FDA: Supplement May Contain Prescription Drug Ingredient:

Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

The FDA promotes drugs that KILL all the time. The FDA does NOT consider natural methods because there's not money in it. The FDA has no problem with all sorts of drugs creating death and other serious issues.

Drugs are recalled and law suits are constant on the FDA approved medications.

Medications cause blood pressure to go up. Do they prescribe high blood pressure meds. High blood pressure meds cause another issue, the prescribe another drug.

And so the cycle goes. FDA is full of hypocrits

Many people who consider taking herbals and dietary supplements, they are being health conscious and may already have health concerns that require treatment. The FDA's press announcement stated that Reumofan Plus and Reumofan Plus Premium, and found dexamethasone, diclofenac sodium, and methocarbamol. The compromised purity of these products had caused many serious health issues. Although this product is not available at pharmacies or hospitals in the US, they are available at some retail outlets, flea markets, and popular internet sites. Sufficient consumer warning should be given to allow consumers to make conscious decisions about dietary supplements to take.

I have an interesting thought on this blog entry. Going back to what I have learned in medicinal chemistry, it is very uncommon for natural drugs to have same chemical structure as synthetic drugs. They usually have complex stereo chemistry which is the reason why they are hard to make synthetically. So how can this supplement contain diclofenac sodium? I can understand they might have similar component as diclofenac but the blog story says diclofenac sodium. If it is really the case that they found diclofenac sodium, then it may be beneficiary to people with arthritis.

I wanted to expand on CW’s comment. The link is to a website for the NIH Office of Dietary Supplements. On that same website there are very helpful dietary supplement fact sheets and information about current dietary supplement research. In addition, the Office of Dietary Supplements holds a week long practicum for students and professionals every June. It is all about the efficacy, safety, science, and legal aspects of using dietary supplements. I found it to be a great experience and if you are interested, you can apply. http://odspracticum.od.nih.gov/

Thanks for publishing this blog! Not that this is a good story but it’s a needed refresher for consumers to realize that not all supplements may be safe. Its scary to think that some people will take supplements without knowing what it is they are taking just because they think it is good for them. A lot of the time, their supplements are interacting with their needed medications. For example, we had a patient who was anemic and finally got her iron under control. Months later it was out of range again and she was upset as to why. She was always compliant with her iron and claimed to be taking no other medications. After asking more probing questions it was discovered that she was taking a combination supplement that was blocking the absorption of her iron. It is so important to let your health care providers know everything that you are taking.

I agree that this is very scary. However, we can educate our patients by telling them to look for the seal of approval on dietary supplements. This website provides information about FAQs regarding dietary supplements: http://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx

I agree with the comment about this is the very reason herbal/natural supplements have a bad rap. The fact that they are not regulated the way prescription drugs are make them less desirable and scary stories like this don't help much either! It's a shame that has happened. I hope not too many people were negatively affected by it. It is important for us healthcare providers to stay up to date on information like this to keep our patients informed.

This is a very scary thought, because a lot of people believe that if anything claims to be “natural”, it “MUST be SAFE”. I am glad the FDA recalled the products and I think the public should be further educated on the fact that, just because a product says “natural” it doesn’t necessarily mean it will be safe for the user.

As someone that travels outside of the country frequently this topic is something I always consider. Recently I spent time in Central Europe, and I wondered about fellow travelers who were making pharmacy purchases at the local apothecary in Prague or Warsaw or Krakow, where FDA regulations cannot interfere. Even if they were picking up a prescription product, they are not guaranteed that they are getting what they are expecting. Especially in Europe, American brands are renamed and given different European brands. In the pharmacy I am always concerned when I hear a patient talking about getting medications or products online rather than coming into a shop to purchase them. It concerns me that we are missing out on a personal interaction with our patients, but also they are missing out on an opportunity to be educated about their medications/natural products.

This post makes me wonder how many supplements currently on the market in the US may actually contain prescription drug ingredients or other unpublicized ingredients as additives in a product. It makes the safety of supplemental products questionable, since they are not strictly regulated and tested by the FDA. The consumer is blinded to the quality, quantity, efficacy, and safety of many products - and we rely on the integrity of the producer to provide a qualified product. Do you think these products should be more firmly regulated in the US? I am interested to hear what other opinions are on this subject.

International travelers often have access to many different types of OTC medications that may not be available in the US. With such access, increased patient knowledge about Reumofan and other OTC products becomes even more important. Patients may not know about the individual ingredients and safety implications of products they take. FDA warnings help raise awareness, but with direct patient contact, health care providers also play a vital role in evaluating the appropriate usage of both prescription and OTC medications and educating patients.

Its events like this that give complementary alternative medicine and herbal/natural supplements bad rap. Although there are a lot less strict regulations regarding these products in the United States, they can still have many benefits. It's a shame that this happens. I don't know about the others, but I am pretty sure diclofenac is available without a prescription in Mexico. I am curious to see what the out come for Reumofan will be- if there will be recalls/ tests on all their products, legal action, etc.

After reading Marina's comment that a Google search for Reumofan produced an FDA warning as the first result, I wondered how often people use the order of Google search results as a basis for decided what is the most reputable. When I did the search I also got the FDA website as my first result, but the second and third results were websites selling Reumofan. A person looking at those results would need to already know that the FDA website was the right place to look. I also wonder what the Google results would look like for a consumer that has never been to the FDA website before, since Google results are tailored to our individual internet histories.

This is definitely something to consider. It’s scary to realize that there are commercial products on the shelf that there is no way of knowing what is in them. It’s unfortunate that some manufacturers of dietary supplements, such as this Mexican one, would put prescription medications into a supplement that is sold in the US. In Mexico though there are not many drugs that are prescription only products, if any, so these manufacturing practices would be all right there. But here in the US, it is not ok to do that.

Wow, this is really serious. Those prescription medications have the potential to cause some significant and very harmful interactions and side effects. It is important that this type of information reaches consumers so that they are aware when this happens. It is nice that Natural Standard highlights this issue. It helps to disperse the information quickly, and therefore, we can more quickly pass it on to those patients who it might affect.

This is unfortunately not very surprising. Supplements in the U.S. are highly unregulated and it is very important for consumers to know that and to only use reliable brands. Just being on a shelf next to a brand you are familiar with does not make a supplement reliable.

Great post! This is definiately not this first time Rx medications have ended up in OTC supplements. Back in 2007 a male stimulatant that was considered "all natural" was found to contain prescription ED medication.While not having supplements regulated by the FDA allows for a wide vairety of natural altenratives for customers to choose from, this is definately a double edged sword, as it is almost too easy to contanimate these products.

This is a scary reality for all herbals and supplements in the US since they are not as highly regulated as prescription drugs. Hopefully manufacturers will take a stand and practice good manufacturing so that the public can be confident in the products they are buying, especially since there is some great scientific evidence for the use of natural products in certain conditions.

It always boggles my mind how these things manage to happen. An alert for this product was actually issued originally back in June, yet people still continued to take it. In addition to the side effects listed in this article, there were also reports of bleeding, stroke, and death. I suppose it doesn't help much that the label on the product is actually written in Spanish. Does anyone know if these prescription drugs that were found are available without a prescription Mexico?

This is crazy and very dangerous. I am glad the FDA caught this mishap, otherwise a lot of patients taking these supplement could have had some tragic adverse effects. Diclofenac, methocarbamol, and dexamethason, are definitely drugs you do not want to take without supervision from a provider, due to risk of gastrointestinal bleed, cardiovascular problems, glycemic problems, withdrawal problems, etc. It great that the FDA found this information out sooner than later!

When I googled Reumofan, I am glad that the first pages to come up were the FDA warnings! The websites that actually sell this to USA and Canada look really unprofessional and untrustworthy. This concoction makes me really scared of buying 'natural' supplements that come from a new company and do not list true ingredients. Diclofenac, dexamethasone and methocarbamol are not to be played around with.

This is really scary! It's definitely important that the products patients are taking are from a reliable manufacturer. Since dietary supplements aren't regulated by the FDA there's no guarantee of efficacy, so even though many products can provide patients with good benefits, there are some out there that can be harmful!

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Working...
Your comment could not be posted. Error type:
Your comment has been saved. Comments are moderated and will not appear until approved by the author. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.

Working...

Post a comment

Comments are moderated, and will not appear until the author has approved them.

Become a Fan