FDA Do Not Use Warning on Mexican Painkillers Artri and Ortiga
Over-the-counter drugs sold under the Artri and Ortiga brand names may contain undeclared drugs and should not be used by U.S. consumers, the Food & Drug Administration warned this week.
“The FDA urges consumers taking these products to immediately speak with their healthcare professional (eg, physician) about safely discontinuing use of the product because stopping these medications suddenly may be dangerous,” said the FDA.
“Suddenly stopping corticosteroids after long-term or high-dose use can lead to a severe withdrawal syndrome that includes fatigue, nausea, low blood pressure, hypoglycemia, fever, dizziness, pain muscles and joints and shortness of breath.
You can find these products, touted as treating arthritis, muscle pain, osteoporosis, and even bone cancer in stores, on eBay, Amazon, and other websites.
In January, the agency issued a warning about a medicinal ingredient hidden in Artri Ajo King. Since then, the FDA says it has received reports of adverse events on Arti King products that include “liver toxicity and death.”
Here’s what you need to know.
Which Artri and Ortiga products are affected?
▪ Artri Ajo King: The FDA says Artri Ajo King contains diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), which is not listed as an ingredient.
“NSAIDs can lead to an increased risk of cardiovascular events, such as heart attacks and strokes, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforations of the stomach and intestines. “, reads the January warning. “This hidden medicinal ingredient may also interact with other medications and significantly increase the risk of adverse events, especially when consumers use multiple NSAID-containing products.”
▪ Arthur King: The FDA says Artri King contains diclofenac and dexamethasone.
“Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions,” an FDA warning said. “The use of corticosteroids can impair a person’s ability to fight infections and can cause high blood sugar, muscle damage and psychiatric problems. When corticosteroids are taken for a long time or in high doses, they can inhibit the adrenal gland.
▪ Ortiga Mas Ajo Rey: The FDA says the lab analysis says diclofenac.
▪ Ortiga Mas Ajo Rey (Extra Strong): Diclofenac, dexamethasone and methocarbamol are not listed ingredients, according to the FDA.
“Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure,” the FDA said. “Methocarbamol may also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.”
What to do if you encounter a problem?
If this or any other drug causes a problem, after telling a healthcare professional, notify the FDA through its MedWatch adverse events page or by completing a form available by calling 800-332- 1088.