A few days ago the FDA released an updated alert on Reumofan Plus and Reumofan Plus Premium. The agency warns that the dietary supplements contain undeclared active ingredients found in prescription drugs - ingredients which only should be administered under the supervision of a health care professional.
These products are sold and promoted as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.
The first warning was issued by the FDA on June 1, 2012, since then the FDA received dozens of adverse reports which include fatalities, and stroke. The agency said other reports have included; liver injury, sudden worsening of glucose (sugar) control, severe bleeding of the gastrointestinal tract, weight gain, swelling, leg cramps, adrenal suppression and corticosteroid withdrawal syndrome.
FDA Update 08/21/2012
Questions and Answers: Reumofan Plus and Reumofan Plus Premium
En Español1
What are Reumofan Plus and Reumofan Plus Premium?
Reumofan Plus and Reumofan Plus Premium are products marketed as natural dietary supplements that contain several potentially harmful active pharmaceutical ingredients. These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. Reumofan Plus and Reumofan Plus Premium are labeled in Spanish, but versions of these products may also exist with English labeling.
Where are Reumofan Plus and Reumofan Plus Premium manufactured and sold?
Reumofan Plus and Reumofan Plus Premium are manufactured in Mexico by Riger Naturals. However, these products have been sold throughout the United States in some retail outlets, at flea markets, and on various Internet sites.
Has FDA received adverse events and/or complaints associated with Reumofan Plus and Reumofan Plus Premium?
Yes, FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning2 about the product on June 1, 2012. Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression.
What hidden ingredients were found in Reumofan Plus and Reumofan Plus Premium?
FDA laboratory analysis revealed that Reumofan Plus contains the undeclared and potentially harmful prescription drug ingredients dexamethasone (a corticosteroid), diclofenac sodium (an anti-inflammatory drug), and methocarbamol (a muscle relaxant). Reumofan Plus Premium was found to contain diclofenac sodium and methocarbamol.
What should consumers do if they have taken Reumofan Plus or Reumofan Plus Premium?
Consumers taking these products are urged to immediately consult with their health care professional (e.g., doctor) to safely discontinue use of the product. The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening, health consequences. The longer the product(s) is taken, the higher the risk of these serious health consequences.
Reumofan Plus contains the corticosteroid, dexamethasone. Abrupt discontinuation of corticosteroids may cause serious withdrawal syndrome and life threatening adrenal suppression. These risks depend upon a number of variables that need to be assessed by a health care professional, and medical intervention may be necessary. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.
What are the risks associated with the undeclared ingredients discovered in Reumofan Plus?
FDA laboratory analysis revealed that Reumofan Plus contains three prescription drug ingredients: dexamethasone, a corticosteroid; diclofenac sodium, an anti-inflammatory drug; and methocarbamol, a muscle relaxant. These ingredients are not listed on the label and could cause serious harm to consumers.
The risks associated with these ingredients include the following:
- Dexamethasone is a potent corticosteroid used primarily for
its anti-inflammatory properties. Corticosteroids can reduce the body’s immune
response to infection and have profound effects on various organ systems in the
body. Dexamethasone and other corticosteroids can cause serious adverse events,
including infections, increased blood glucose (sugar) levels, changes in blood
pressure, damage to bones, psychiatric problems, and adrenal dysfunction.
In addition to the adverse effects that can result from using corticosteroids, the sudden discontinuation of corticosteroids can also have health consequences. Sudden discontinuation of corticosteroids after long-term use or high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath.
- Diclofenac sodium is a non-steroidal anti-inflammatory
(NSAID) drug that can cause increased risk of cardiovascular events, such as
heart attack and stroke. Diclofenac, like other NSAID drugs, can also lead to
serious gastrointestinal (GI) adverse events, including bleeding, ulceration,
and fatal perforation of the stomach and intestines.
The potential drug interactions that can occur with the hidden diclofenac sodium component of Reumofan Plus and Reumofan Plus Premium are serious. Consumers who take Reumofan Plus and/or Reumofan Plus Premium increase their risk of bleeding and the complications of bleeding. Patients already may be taking other medications/products that can cause bleeding. Taking multiple products that have a risk of bleeding significantly increases the risk and the severity of the bleeding if it does occur.
- Methocarbomal is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbomal can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. The risk of injury or death is significantly increased when Reumofan Plus and/or Reumofan plus Premium are taken with other medications/products that can cause these impairments.
Does FDA suspect that Reumofan Plus and Reumofan Plus Premium may contain other unlabeled ingredients?
FDA analysis reflects only the undeclared ingredients discovered in one product from a specific lot, but ingredients may vary from product to product or from lot to lot. Products marketed as dietary supplements that are found to have hidden drug ingredients generally fail to comply with most current good manufacturing practices designed to ensure product quality and safety. Therefore, consumers should expect that the manufacturing processes for Reumofan Plus and Reumofan Plus Premium are unreliable in their ability to provide consistent amounts of active ingredients or to prevent the introduction of unknown chemicals or other impurities.
What should health care professionals do if they suspect or confirm patients have taken Reumofan Plus or Reumofan Plus Premium?
Health care professionals should evaluate patients who have used Reumofan Plus/Reumofan Plus Premium for drug and disease interactions involving diclofenac, methacarbamol, and corticosteroids, and treat accordingly.
When indicated, health care professionals should evaluate adrenal function and consider whether a corticosteroid taper regimen is appropriate in patients who have used Reumofan Plus and/or Reumofan Plus Premium.
What action is FDA taking?
FDA has issued a public health advisory to highlight the health risks of Reumofan Plus and Reumofan Plus Premium. In addition, FDA is investigating the distribution of these products in the United States. FDA may take additional enforcement steps that may include warning letters, seizure, injunction, or criminal charges.
How should consumers report problems to FDA?
Consumers should report serious side effects or product quality problems with the use of these products to FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.
- Online3
- Regular Mail: Use FDA postage paid form 35004 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
No comments:
Post a Comment