FDA issues further warnings on ‘supplements’ spiked with omeprazole, diclofenac

The U.S. Food and Drug Administration last week warned consumers not to use or purchase some products marketed as dietary supplements, including one associated with an increase in adverse event reports since the agency issued a warning over the summer.

FDA laboratory testing discovered the products called Umary and Amazy contain drug ingredients not listed on the product label, namely diclofenac and omeprazole.

FDA has warned NSAIDs (non-steroidal anti-inflammatory drugs) like diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, and serious gastrointestinal damage, including bleeding, fatal perforation of the stomach and intestines, and ulceration. Omeprazole is a proton pump inhibitor (frequently referred to as a PPI) used to treat gastric (stomach) acid-related disorders.

In a Sept. 5 advisory, FDA noted the products are promoted to treat pain and other conditions and are sold on various websites, including SoloVital, Main Products and Amazon, and in some retail stores.

“FDA has received an increase in adverse event reports with the use of Umary products since the agency issued a warning in June 2024,” the agency shared in the advisory. “The adverse event reports are consistent with known common adverse reactions such as gastrointestinal, cardiovascular and serious skin reactions associated with the drug ingredients found in Umary.”

Related:Anti-inflammatory drug diclofenac continues to show up in ‘supplements,’ FDA warns

FDA recently issued a warning letter to SoloVital for selling Umary, while in July 2024, Main Products and SoloVital recalled Umary products.

In the Aug. 27 warning letter addressed to German Alegre of SoloVital, an FDA official with the Center for Drug Evaluation and Research (CDER) — Captain Tina Smith, director of CDER’s Office of Unapproved Drugs and Labeling Compliance — said FDA lab analysis found Umary contained undeclared diclofenac and omeprazole. The product also is described on the website as “Umary Hyaluronic Acid," according to the letter.

FDA concluded diclofenac cannot be marketed in a dietary supplement because it was first approved under the trade name Voltaren as a new drug on July 28, 1988. Commenting on omeprazole, Smith wrote, “PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers and stomach cancer, and it can also interact with other medications and should not be taken with certain medications.”

The FDA official warned SoloVital that failure to address issues identified in the letter may result in legal action, including an injunction and seizure. SoloVital did not immediately respond to a request for comment for this story.

Related:Distributor ignores FDA warning over anti-inflammatory drug in supplement

Over the summer, Flora Research Laboratories LLC also found the presence of diclofenac and omeprazole in samples of Umary that it tested for two consumers, said the lab’s founder and director James “Jim” Kababick. He previously told SupplySide Supplement Journal (formerly known as Natural Products Insider) that his company was contacted by someone whose colleague was taking Umary and expressed “serious concerns” given the effectiveness of the product within a day of consumption. Another consumer also reached out to the lab to test Umary for drugs due to its effectiveness, Kababick said.

He said the tests were shared with FDA. Consumers for whom Umary was tested did not mention any adverse health effects from taking the product, Kababick said, though he warned that doesn’t mean people aren’t suffering adverse effects and reporting them to FDA.

“The addition of a proton pump inhibitor seems to be an attempt to counteract the severe stomach damage that can occur from high doses of diclofenac,” Kababick explained in a June 24 email. “There are also cardiovascular risks associated with this drug.”