Transgressions committed by dietary supplement manufacturers continue to cast doubt throughout the entire industry. Increasingly, companies are neglecting to follow the laws set forth by federal authorities. Of significant concern, however, is the current trend of adding undisclosed and potentially dangerous active ingredients to dietary supplements. The U.S. Food and Drug Administration (FDA) has recently received dozens of reports of harmful side effects – including stroke and death – linked to two dietary supplements currently on the market, Reumofan Plus and Reumofan Plus Premium.
Reumofan Plus and Reumofan Plus Premium, each a product of the Mexico-based Riger Naturals, are intended to relieve joint and muscle pain caused by degenerative bone conditions. However, these dietary supplements claim to be most effective in the treatment of arthritis, rheumatism, knee, back, shoulder, elbow, wrist pain, tendonitis, osteoporosis, heel, and spur pain. Both Reumofan Plus and Reumofan Plus Premium claim to be 100% natural, consisting of ingredients found in Mexican herbalary and countries like Cuba and India.
However, an FDA lab analysis of Riger Natural facilities discovered trace amounts of undisclosed ingredients contained within their products. According to a subsequent FDA Press Release, “The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.” Ongoing FDA laboratory analyses of Reumofan Plus found that it contains the following prescription drug ingredients:
- Dexamethasone – a corticosteroid, commonly used to treat inflammatory conditions, that can impair the body’s ability to fight infections and cause high blood sugar levels, bone and muscle injuries, and psychiatric problems. Dexamethasone can also cause adrenal suppression when taken for a prolonged period of time or at high doses. Sudden discontinuation of corticosteroids after long-term use or use at high doses can result in a withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.
- Diclofenac Sodium – a 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 of the stomach and intestines.
- Methocarbamol – a 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.
Also mentioned in the FDA Press Release, was the inclusion of diclofenac sodium and methocarbamol in Reumofan Plus Premium products.
Complicating the already volatile situation surrounding these products are dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning 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.
Each product is manufactured in Mexico, but sold in the United States in retail outlets, flea markets, and on various popular Internet sites. Labels consist mainly of the spanish language, but english labels are becoming more common. Officials at the FDA are working closely with the Mexican government and says the Mexican Ministry of Health issued a health warning to the public and ordered Riger Naturals to recall the products.
“Consumers taking these products are urged to immediately consult with their doctor to safely discontinue use of the product,” said FDA spokeswoman Sarah Clark-Lynn. “The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening health consequences. The longer the product is taken, the higher the risk of these serious health consequences.”
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