"We found that changes to acetaminophen labels that communicated the risks of overdose and the presence of acetaminophen in over-the-counter products did not affect rates of hospital admission for accidental acetaminophen overdose, ICU admission for accidental acetaminophen overdose and admission for acetaminophen overdoses involving opioids," writes lead author Dr. Tony Antoniou, Li Ka Shing Knowledge Institute, St. 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. 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. The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. Both drugs can also interact with other medications. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”ĭiclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage.
It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies.
Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.
Methocarbamol may cause dizziness and low blood pressure, it said.“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. The Artri King products are made by supplements maker NaturaMex.ĭexamethasone could cause serious adverse events including infections and elevated sugar levels while diclofenac sodium could lead to heart attack and stroke or gastrointestinal damage, the FDA warned on Wednesday.
The agency said it has received reports of adverse events including of liver toxicity and death, associated with the use of Artri King products since the warning. The FDA in January had first issued a warning about Artri Ajo King, asking consumers not to purchase the product sold for joint pain and arthritis on various websites, including. The FDA said it found the hidden drug ingredients in Artri Ajo King, Artri King, Ortiga Mas Ajo Rey and Ortiga Mas Ajo Rey Extra Forte products. The products are marketed to treat arthritis, muscle pain and other conditions and are sold online and in some retail stores, the agency said.
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