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Posted September 23, 2014

Maker of Joint and Weight Products Warned for Hidden Drugs, Manufacturing Violations

On September 15, 2014, the FDA issued a warning letter to West Coast Laboratories, Inc., because the company's joint health supplements, Super ArthGold and Pro ArthMax, were found to contain hidden drugs. These drugs can cause serious side-effects, and may increase the risk of serious side-effects in people who are taking other medications, especially anti-inflammatory drugs.

Super ArthGold was found to contain undeclared chlorzoxazone, indomethacin, and piroxicam. (Two lots of SuperArthGold found to contain these drugs were recalled by a retailer in April 2014.)

Pro ArthMax was found to contain multiple drugs, including diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone. (The FDA first warned consumers about the hidden drugs in ProArthMax in January 2014.)

Chlorzoxazone is a prescription muscle relaxant which can cause drowsiness and dizziness, and may interfere with the ability to perform certain tasks such as driving or operating machinery.

Diclofenac, ibuprofen, naproxen, piroxicam and indomethacin are non-steroid anti-inflammatory drugs (NSAIDs), which can increase the risk of cardiovascular events and gastrointestinal damage, such as bleeding, ulceration, and fatal perforation of the stomach.

Nefopam is non-narcotic pain relief drug that is not FDA-approved for marketing in the U.S. Rapid heart rate, sweating, dizziness, confusion, hallucinations, and seizures have been reported with the use of this drug.

FDA analysis found the company's "HerbAid Powder", an ingredient used to make both Super ArthGold and Pro ArthMax, contained the hidden drugs.

(See's Review of Joint Health Supplements for tests of related products.)

In addition, the company's products, including Nano Cal/Mag, Lipozene, Metabo Up Plus and Prenatal Formula with Folic Acid, were found to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, failure to establish and follow written procedures for the responsibilities of the quality control operations and failure to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement.

Nano Cal/Mag contains calcium and magnesium. (See's Reviews of Calcium Supplements and Magnesium Supplements for tests of related products.)

Lipozene contains glucomannan and is promoted for weight loss. (See's Review of Weight Loss Supplements for more information about glucomannan and tests of related products.)

Metabo Up Plus contains green tea extract, guarana seed extract, caffeine, Oolong tea leaf, kola nut extract, cayenne fruit, vitamin B6, vitamin B12 and Platycodon grandiflorum root extract. It is promoted for energy and weight loss. (See's Reviews of Green Tea Supplements and B Vitamin Supplements for tests of related products.)

Prenatal Formula with Folic Acid contains manganese, copper, zinc, magnesium, potassium, iodine, iron, niacinamide granular, vitamin A palmitate, vitamin D, thiamine mononitrate, riboflavin powder, vitamin B-6, folic Acid, cyanocobalamin, calcium, and ascorbic acid. (See's Review of Multivitamin and Multimineral Supplements for tests of other prenatal vitamin supplements.)

See Related Warnings:

Arthritis Supplement Containing Multiple Drugs Recalled

FDA Warns Consumers of Supplement Containing Prescription Anti-Inflammatory Drug

Recall: Arthritis and Muscle Pain Supplement Contains Prescription Drugs

Dangerous Supplement Being Sold Under New Name

FDA Warns of Life-Threatening Side Effects and Withdrawal Symptoms from Two Arthritis, Muscle Pain Supplements

FDA Warning on Supplement for Pain Relief

To read the FDA's warning, use the link below.