![]() ![]() In an analysis of more than 12 000 hospital admissions for acetaminophen overdoses in Canada between 2004 and 2020, researchers found the updated warning labels had little impact. In 2016, the labeling was updated with additional information about safe dosing and to identify products containing acetaminophen.īut those changes did not decrease rates of hospitalization for acetaminophen overdoses, according to a new study published in CMAJ (Canadian Medical Association Journal). Product labels for acetaminophen were changed in Canada in 2009 to warn of the risk of possible liver damage. Such is the case for warnings from Health Canada about taking high doses of acetaminophen, a pain reliever widely used in over-the-counter medicines for headache, cough, cold and flu. ![]() ![]() Sometimes warnings from government health agencies don’t have their intended impact. The FDA’s new warnings include Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte supplements, which are promoted as treatments for joint pain and arthritis.Īrtri King and Ortiga sold their products on various websites, including Amazon, Walmart and E-Bay, as well as some retail stores, primarily targeting Spanish-speaking consumers. A second warning about Artri King was issued this week. The FDA said it has received reports of adverse events, including liver toxicity and death, associated with the use of Artri Ajo King supplements since the agency issued its first warning on January 5, 2022. The drugs may also interact with other medications a person is taking. Consumers should exercise caution before purchasing any product in the above categories.The FDA urges consumers taking the supplements to immediately talk to a healthcare provider about safely discontinuing their use because suddenly stopping the undeclared drugs may be dangerous. These products are typically promoted to unsuspecting customers for sexual enhancement, weight loss, and body building, or for other medical uses and are often represented as being “all natural.” FDA is unable to identify and test all such products that may have potentially harmful hidden ingredients. Note: The purpose of this notification is to inform the public of a growing trend of dietary supplements or conventional foods containing hidden drugs and chemicals. Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.Complete and submit the report Online:.Health care professionals and patients are encouraged to report adverse events or side effects related to Ortiga to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Consumers should consult a health care professional as soon as possible if they have experienced any negative side effects, such as unusually dark stools or urine, stomach pain, increased bruising, or other signs of bleeding. 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.Ĭonsumers should stop using this product immediately and dispose of it. NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). The product is manufactured in Mexico and labeled primarily in Spanish.įDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. The Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites, including and in some retail stores.
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