FDA Issues Alert on Reumofan Plus

Reumofan Plus, marketed as a “natural” dietary supplement contains active pharmaceutical ingredients not listed on the label that could be harmful, according to the Food and Drug Administration.

“Dietary Supplement” Contains Potentially Harmful Pharmaceutical Ingredients

Wallingford, CT - July 25, 2012 – The U.S. Food and Drug Administration (FDA) is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking the product should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites.

The FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of blood sugar levels, weight gain, swelling, leg cramps, and kidney function problems.

An FDA laboratory analysis of Reumofan Plus found that it contains:

  • diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.
  • methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities when performing tasks such as driving a motor vehicle or operating machinery.  

These ingredients also may interact with other medications and result in serious side effects.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

According to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids.
At least one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

For more information and updates, read the warning on the FDA website.

This post is contributed by a community member. The views expressed in this blog are those of the author and do not necessarily reflect those of Patch Media Corporation. Everyone is welcome to submit a post to Patch. If you'd like to post a blog, go here to get started.

Kelly P July 29, 2012 at 07:47 PM
Now, where are the comments from those who claim they are losing liberty by not having the choice to ingest this harmful product? Where are the comments form people who claim that govt is intruding on their lives by holding the manufacturer of this harmful product to account for adverse effects? Where are the comments from people who think self-regulation is sufficient? Where are the comments from people who think that there is too much regulation? Could it be that this FDA activity is actually protecting people? Could it be that the manufacturer is based on Mexico because the U.S. wouldn't permit this (or strives not to allow this)? Could it be that oversight of, gasp, a federal regulatory body is helping to protect lives? Could it be that, however imperfect, the intent of the regulatory structure for food and drugs actually helps prevent abuses? Nah, that couldn't possibly be the case ... or could it?


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