The Federal Drug Administration (FDA) released a warning to consumers about the over-the-counter (OTC) products of Reumofan Plus and Reumofan Plus Premium containing prescription level drugs. Anyone purchasing these products between February and June 2012 and consuming the pills should consult with their healthcare provider. Abrupt stopping of Reumofan dietary supplement may produce steroid withdrawal if the pills contain steroids. The possible undeclared ingredients may include Diclofenac, Methocarbamol and Dexamethasone.
The manufacturer, Riger Naturals, of the OTC drugs, Reumofan Plus and Reumofan Plus Premium, sold the drug in stores, flea markets and on the internet. This dietary supplement is purported to treat such chronic conditions as arthritis, joint pain, tendonitis and osteoporosis. According to the product ingredient list, the supplement being recalled contained such substances as Guasima, Holm Oak, Eastern Teaberry, Cancerina, Matarique, Shark Cartilage, White Willow, Glucosamine, Curcumin, Vitamin C and E, Magnesium and Calcium. Riger Naturals contend these substances produce such healthy benefits as anti-inflammatory, pain relieving and antioxidant properties.
Unapproved ingredients found in the pills
The FDA laboratory found the two prescription medications of Diclofenac Sodium and Methocarbamol in the Reumofan Plus pills. Since Diclofenac is a non-steroidal anti-inflammatory drug, this medical increases the risk of heart attacks, strokes, stomach or intestinal bleeding. The drug, Methocarbamol, used for muscle relaxation produces side effects of sleepiness, dizziness, low blood pressure and impaired mental or physical capability to perform tasks like driving a car. The Mexican Ministry of Health uncovered a lot of the pills containing the steroid drug, Dexamethasone. This steroid drug works as an anti-inflammatory and immune suppressing medication.
Reported adverse effects of Reumofan products
Safe Medicines Organization posted pictures of the drug packaging and bottle. The containers may be in English or Spanish. Most recently, the FDA announced reports of the dangers associated with the Reumofan product. Multiple reports of strokes, severe bleeding from the gastrointestinal tract, insomnia, high blood sugar, weight gain, difficulty sleeping, steroid withdrawal and deaths occurred in individuals consuming this dietary supplement in the US.
Prescription versus OTC medications
The law fails to require the FDA to test OTC drugs for safety and effectiveness prior to the substance going on the market like the requirements for prescription drugs. Therefore, the FDA relies on consumers to report adverse events, suspicions and concerns when issues with an OTC product arise. The FDA reporting process can be found online at MedWatch.
FDA advice to consumers
The FDA advises consumers to desist from buying or initiating use of this product, because the dietary supplement may cause serious or fatal side effects. Consumers on the product, or ones who recently quit taking the pills, need to contact their health care provider as soon as possible to determine any adverse effects or interaction with other medications. The dietary supplement recall assists in removing the product from the market.