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Wednesday, June 06, 2012

Reumofan Plus Alert By FDA | Health Officials In Mexico Recall The Dietary Supplement

FDA, Food and Drug Administration has issued an alert on Reumofan Plus found in the market as a Natural dietary supplement for conditions involving pain relief and treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions..
Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

FDA analysts found several active pharmaceutical ingredients not listed on the label that could be harmful;

  • 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 to perform tasks such as driving a motor vehicle or operating machinery. 
Following is the press release by FDA; (Comunicado de prensa En EspaƱol)


For Immediate Release: June 1, 2012
1Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA issues alert on Reumofan PlusHealth officials in Mexico order recall based on potentially harmful pharmaceutical ingredients
The U.S. Food and Drug Administration 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 Reumofan Plus 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. 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 glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).
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 to perform tasks such as driving a motor vehicle or operating machinery.
These ingredients also may interact with other medications and result in serious adverse events.
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:
  • online at www.fda.gov/Medwatch/report.htm3;
  • by phone at 800-FDA-1088 (800-332-1088); or,
  • by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.

Monday, May 14, 2012

FDA Warns on potential dangers of unproven treatment for multiple sclerosis


FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

 
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).
 
Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause multiple sclerosis (MS) or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.
 
“Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”
 
The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.
 
MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.
 
Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
 
The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.
 
In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.
 
The FDA will continue to monitor reports of adverse events associated with “liberation therapy” or the “liberation procedure” and keep the public informed as new safety information becomes available.
 
For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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