Posts Tagged ‘“dietary supplement”’

Those who take so-called “natural dietary supplements” want to listen to the Food and Drug Administration’s (FDA) latest alert on Reumofan Plus and Reumofan Plus Premium, which have now been linked to cases of death and stroke.

“Consumers who are currently taking Reumofan Plus or Reumofan Plus Premium, or who have recently stopped taking it, should immediately consult a health care professional,” said Elizabeth Miller, Pharm.D., acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud.

The FDA issued its first alert on the dangers of Reumofan Plus on June 1, stating the drug had several active pharmaceutical ingredients not listed on the label. This week, the agency issued an updated alert for both the drug and Reumofan Plus Premium, saying it had since received reports of death, stroke and these symptoms:

• Severe bleeding in the gastrointestinal tract
• Dizziness
• Insomnia
• High blood sugar levels
• Problems with liver and kidney functions
• Corticosteroid withdrawal syndrome

These defective products are marketed as natural dietary supplements which treat arthritis, muscle pain, osteoporosis and bone cancer. If not properly supervised by a medical professional, those who stop taking the supplements can face serious withdrawal symptoms.

The defective drugs may contain corticosteroids and abrupt discontinuation can supress the adrenal glands, which regulate a number of hormone and body functions. Users could experience fatigue, low blood sugar levels, fainting and other symptoms.

The Reumofan products are manufactured in Mexico by Riger Naturals and sold on the Internet, flea markets and some retail outlets. The Mexican Ministry of Health has also issued a health warning to its citizens and ordered Riger Naturals to recall the products.

FDA testing of Reumofan Plus and Reumofan Plus Premium show they contain two ingredients which require prescriptions: diclofenac sodium and methocarbamol. Reumofan Plus also contained dexamethason, a type of corticosteroid.

The FDA offers consumers these tips for avoiding defective and dangerous drugs:

• Be wary of off-the-counter products which only have prescription counterparts.
• Be cautious when a label has a foreign language.
• Be aware that so-called “natural dietary supplements” are not subject to the same FDA pre-market review as prescription drugs and some over-the-counter drugs.

Related:

• Reumofan Products Pose Risk to Consumers, Food and Drug Administration.
• Dietary Supplements, Food and Drug Administration.

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