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

FDA continues to find diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in products marketed as supplements.

On June 20, in a health fraud advisory, FDA advised consumers not to purchase or use a product (Infla-650) promoted and sold for pain on various websites, including www.nutraherbusa.com, and perhaps in some retail stores. FDA lab analysis verified the product contained three undeclared drug ingredients: diclofenac, phenylbutazone and acetaminophen, a medicine used to reduce pain and fever found in many prescription and over-the-counter (OTC) drug products.

The FDA advisory displayed a picture of Infla-650, which contained a “Supplement Facts” panel.

“Use of the product Infla-650 poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products,” FDA stated. “Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash and blisters.”

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

FDA warned NSAIDs 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.

“This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products,” the agency added.

The other compound found in Infla-650, phenylbutazone, is an NSAID discontinued for human use in the U.S. due to risk of serious and life-threatening injuries, including a condition (bone marrow toxicity) that occurs when the body fails to produce sufficient red and white blood cells and/or platelets, FDA said.

The FDA advisory is among those notifications alerting the public of products marketed as conventional foods or dietary supplements with concealed chemicals and drug ingredients.

“These products are typically promoted for sexual enhancement, weight loss and body building and are often represented as being ‘all natural,’” the agency stated in the Infla-650 medication health fraud advisory. “FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.”

An investigation published in May by Natural Products Insider found that a distributor of a product promoted for arthritis and joint pain and containing three undeclared drugs — including diclofenac — continued to sell the product, even after a consumer advisory was issued and the firm was warned by FDA that it was in violation of the law.

Preston Williams, M.D., a senior internal medicine resident at Cambridge Health Alliance and clinical fellow at Harvard Medical School, told Natural Products Insider in the above investigation that prescription-level doses of diclofenac unknowingly consumed by a person with cirrhosis or chronic kidney disease could greatly endanger their health and worsen their liver failure.

Yet, FDA continues to find diclofenac sold on various websites. In a separate advisory published on June 14, FDA recommended consumers not purchase or use a product (Umary) promoted and sold for pain on various websites, including www.solovital.com, and possibly in some retail stores. FDA confirmed through lab analysis that the product contained diclofenac and omeprazole, a proton pump inhibitor (frequently referred to as a PPI) used to treat gastric (stomach) acid-related disorders.

“PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea and headache,” FDA said in the advisory. “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.”

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 told 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 completed this week and 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.

Natural Products Insider reached out Monday after business hours to FDA for comment on whether it has received any adverse event reports tied to the products above.

“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 added. “There are also cardiovascular risks associated with this drug.”

FDA recommended that consumers and health care professionals report adverse events or side effects related to the use of such products above to its MedWatch Safety Information and Adverse Event Reporting Program. People can complete and submit the report online at MedWatch Online Voluntary Reporting Form, or download and complete the form, then submit it via fax at 1-800-FDA-0178.

Nutraherbusa, a seller of Infla-650 identified by FDA, did not immediately respond to a request for comment. SoloVital, which FDA identified as a seller of Umary, also did not immediately respond to a request for comment.