The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law.
The FDA is particularly concerned about unapproved injectable drug products because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm.
Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research
THESE PRODUCTS ARE FURTHER CONCERNING GIVEN THAT THEY ARE LABELED TO CONTAIN POTENTIALLY TOXIC INGREDIENTS INTENDED FOR INJECTION DIRECTLY INTO THE BODY. THESE WARNING LETTERS REFLECT OUR CONTINUED COMMITMENT TO PATIENT SAFETY.
No currently marketed drug products labeled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins...
Full text at GMPnews.Net