Over-the-counter medications sold under the brands Artri and Ortiga could contain undeclared drugs and shouldn’t be used by U.S. consumers, the Food & Drug Administration warned this week.
“FDA urges consumers taking these products to immediately talk to their health care professional (e.g., doctor) to safely discontinue use of the product because suddenly stopping these drugs may be dangerous,” the FDA warning said.
“Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, 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 hidden drug ingredient in Artri Ajo King. Since then, the FDA claims it’s received adverse event reports about Arti King products that include “liver toxicity and death.”
Here’s what you need to know.
What Artri and Ortiga products are involved?
▪ Artri Ajo King: The FDA says Artri Ajo King contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID), that isn’t listed among the ingredients.
“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,” the January warning said. “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.”
▪ Artri King: The FDA says Artri King contains diclofenac and dexamethasone.
“Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions,” an FDA warning said. “Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland.”
▪ Ortiga Mas Ajo Rey: The FDA says laboratory analysis says diclofenac.
▪ Ortiga Mas Ajo Rey (Extra Forte): Diclofenac, dexamethasone, and methocarbamol aren’t listed ingredients, according to the FDA.
“Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure,” the FDA said. “Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.”
What should you do if you experience a problem?
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.