FDA warns against Ort-Flx over undisclosed drug ingredients

The Food and Drug Administration is warning consumers not to buy or use Ort-Flx, a product marketed for pain, arthritis, and allergies on multiple websites, including eBay, and possibly in some retail stores.

Laboratory testing by the FDA found that Ort-Flx contains diclofenac, dexamethasone, and methocarbamol that are not listed on the label.

Diclofenac is a pain and inflammation medicine in the NSAID class. NSAIDs can raise the risk of serious heart complications, including heart attack and stroke, and may also cause dangerous gastrointestinal injuries such as bleeding, ulcers, or life-threatening tears in the stomach or intestinal lining. Diclofenac can also interact with other medicines, especially products that contain other NSAIDs, and may substantially increase the chance of these severe side effects.

Dexamethasone is a steroid used to reduce inflammation. It can weaken the immune system, making it harder for the body to fight infections. It may also lead to high blood sugar, muscle damage, and mental health problems.

Anyone using Ort-Flx should contact a health care professional right away to stop using the product safely. A clinician should assess the risk of corticosteroid withdrawal.

Methocarbamol is a muscle relaxant that can cause drowsiness, dizziness, and low blood pressure. These effects can make driving or operating heavy machinery unsafe.

Health care professionals and consumers should report any adverse events or side effects linked to this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Submit the report online through the MedWatch Online Voluntary Reporting Form, or
• Download and complete the form, then send it by fax to 1-800-FDA-0178.

This alert is meant to inform the public about products that may be marketed as dietary supplements or conventional foods but contain hidden ingredients. These items are often promoted for sexual enhancement, weight loss, pain relief, and bodybuilding, and are frequently described as natural. Consumers should use caution before buying such products.

The FDA cannot test and identify every dietary supplement product that may contain potentially harmful hidden ingredients.