FDA Warns Two Pain Products Contain Hidden Prescription Drug Ingredients: RX7 Articulaciones and Ort-Flx Sold Online
The U.S. Food and Drug Administration (FDA) issued two public notifications on October 28 advising consumers not to purchase or use RX7 Articulaciones and Ort-Flx. The products, promoted for joint and muscle pain and for pain and arthritis, are sold on various websites including eBay and may also be sold in some retail stores. FDA laboratory analysis confirmed that both products contain prescription drug ingredients not listed on their labels.
RX7 Articulaciones was found to contain diclofenac and dexamethasone. Ort-Flx was found to contain diclofenac, dexamethasone and methocarbamol, none of them listed on the label.
The FDA says diclofenac, a nonsteroidal anti-inflammatory drug, can increase the risk of serious heart problems such as heart attack and stroke, and can cause gastrointestinal bleeding, ulcers or life-threatening tears in the stomach or intestinal lining; it can also interact with other medications, especially other NSAID-containing products. Dexamethasone, a steroid, can weaken the immune system, raise blood sugar, and cause muscle damage and mental health problems. Methocarbamol, a muscle relaxant, can cause drowsiness, dizziness and low blood pressure, making driving or operating heavy machinery unsafe.
Consumers taking either product should immediately consult a health care professional to safely discontinue use, the FDA says, and the risks of withdrawal from corticosteroids should be assessed by a health care professional. Adverse events can be reported through the FDA MedWatch program, online or by fax at 1-800-FDA-0178.
The FDA says such notifications cover products marketed as dietary supplements or conventional foods with hidden ingredients, which are typically promoted for pain relief and often represented as all natural, and urges caution before purchasing them. The agency notes it is unable to test and identify all supplement products with potentially harmful hidden ingredients on the market.
Source: GSM · USA (original Chinese edition)
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