TOPIC: Artri and Ortiga Products: CDER Alert - FDA Warns Patients and Health Care Professionals Not to Purchase or Use
AUDIENCE: Patient, Health Professional
ISSUE: FDA is warning patients and health care professionals not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label.
These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions and are sold on various websites and in some retail stores.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: FDA laboratory analyses revealed certain Artri and Ortiga products contain the undeclared drug ingredients:
-
Dexamethasone (a corticosteroid) that can cause serious adverse events, including infections, increased blood glucose (sugar) levels, changes in blood pressure, damage to bones, psychiatric problems, and adrenal dysfunction;
-
Diclofenac sodium (an anti-inflammatory drug) that can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death
-
Methocarbamol (a muscle relaxant) that can cause sedation, dizziness, and low blood pressure.
These drug ingredients, which are not listed on the product label, can also interact with other drugs a consumer is taking.
RECOMMENDATIONS:
- Patients taking these products should 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.
- Health Care Professionals should evaluate patients who have used Artri and Ortiga products for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and treat accordingly.
|
