ClickCease FDA Warning on Some OTC Pain Meds | Easy Drug Card

FDA Warning on Some OTC Pain Meds

FDA warns about hidden drug ingredients in certain supplements for pain

If you use supplements to help with your pain, this warning could be for you. In April 2022, the US Food and Drug Administration (FDA) released another warning about supplements branded for treating pain associated with arthritis, osteoporosis, bone cancer, or muscle pain. Supplements including the names Artri and Ortiga were found to contain hidden drug ingredients that could cause harm. These include products with names such as Artri Ajo King, Artri King, Ortiga Mas Ajo Rey, and Ortiga Mas Ajo Rey Extra Forte. If you use any of these products regularly, the FDA warns that you should seek the help of a healthcare professional for information on how to safely discontinue the medication. Some of the drug ingredients can be dangerous to stop suddenly.

Upon analysis by the FDA laboratory, certain Artri and Ortega products were found to contain three different drugs that were not listed on the product and typically require a prescription in the United States. These drugs include dexamethasone, diclofenac, and methocarbamol.

Dexamethasone is a corticosteroid medication that can cause serious side effects including high blood sugar, compromised immune system, infections, blood pressure changes, and/or damage to bones, to name a few. You should not stop dexamethasone suddenly after long-term use because it could lead to serious withdrawal, which is why the FDA recommends seeking help from a medical professional to appropriately discontinue the medication before stopping on your own.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), like ibuprofen, naproxen, and aspirin. This medication can cause serious problems as well, especially for people with certain health conditions, like heart failure, kidney disease, or high blood pressure. Diclofenac interacts with multiple medications. Diclofenac should not be taken blood thinners, as it interacts to increase the risk of bleeding. It also interacts with certain blood pressure medications (ex. lisinopril), where it can decrease the effectiveness of the blood pressure lowering medication. Diclofenac has been associated with serious side effects like heart attack, stroke, ulcers, and/or kidney or liver failure.

The final drug they found in these products is called methocarbamol, which is a muscle relaxer. Methocarbamol can lead to side effects such as sedation, dizziness, or low blood pressure and can interact with other medications with sedating side effects.

The amounts of these drugs found in each product may vary from product to product. FDA also warns that since these hidden drugs were found in the supplements, it may also indicate that the process of making them is likely noncompliant with good manufacturing processes. Thus, the safety and quality of the products themselves cannot be guaranteed. Currently, the FDA is working on decreasing the distribution of these products in the US. They are advising certain companies not to sell or distribute these products at this time, but they may still be in circulation. The FDA will continue to monitor, but consumers are warned of the possible dangers. Talk with your healthcare provider right away if you’re taking any of these products.


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Dr. Andrea M. Jones

Dr. Andrea M. Jones is a clinical pharmacist specializing in transitions of care to facilitate a smooth transition for patients between the hospital and outpatient settings. Dr. Jones graduated from the University of Colorado School of Pharmacy and completed post-graduate year 1 residency at the Southern Arizona VA Healthcare System in Tucson, Arizona. Dr. Jones also worked in retail/community pharmacies for over 5 years during undergraduate studies at the University of Kentucky and pharmacy school at the University of Colorado.




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