The Food and Drug Administration (FDA) has issued warning letters to four companies for selling unapproved injectable drugs under the homeopathic label.
The FDA said in a statement on June 16 that the drugs can pose a serious risk to patients’ life and violate federal law. All the drugs included in the letters are new.
The federal agency issued warning letters to Hervert Pharmaceuticals, LLC; MediNatura, Inc.; Viatrexx; and World Health Advanced Technologies, Ltd.
“These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance of the FDA in a statement.
The FDA said the drugs are injected directly into the bloodstream and bypass some of the body’s key natural defenses against toxins, toxic ingredients, and life-threatening organisms.
Homeopathic drugs are made from a variety of sources like plants, healthy or diseased animal or human sources, minerals, and chemicals, and these ingredients may contain poisons.
“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,” said Ashley.
The FDA said these concerns only become more serious if the homeopathic drugs are poorly manufactured. The agency referred to Viatrexx for the substandard manufacture of sterile drugs.
“Many of the drugs were labeled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), Mercurius solubilis (mercury), and plumbum aceticum (lead),” the agency further noted.
Nux vomica contains strychnine, a well-known poison to kill rodents.
The agency also put several manufacturers of injectable drugs on an import alert, meaning unapproved drugs can be detained without physical examination.
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