FDA Cracks Down on Unapproved Injections

(RxWiki News) The US Food and Drug Administration (FDA) has sent warning letters to four companies for selling unapproved injections.

The FDA sent warning letters to the following companies for selling unapproved and potentially dangerous injectable drugs:

• Hevert Pharmaceuticals, LLC
• MediNatura, Inc.
• 8046255 Canada, Inc., doing business as Viatrexx
• World Health Advanced Technologies, Ltd

One company’s product was being marketed for tuberculosis and hepatitis B and C.

These companies’ products were labeled as “homeopathic.” Homeopathic products can be made of ingredients derived from plants, healthy or diseased animal or human sources, and minerals or chemicals.

These products can also include known poisons or toxins. But they are often advertised as natural and safe. Furthermore, they may be marketed as alternatives to approved prescriptions.

Toxins that may be present in these so-called homeopathic injections include the following, according to the FDA:

• Nux vomica
• Belladonna (deadly nightshade)
• Mercurius solubilis (mercury)
• Plumbum aceticum (lead)

These products are injected directly into the body and, in some cases, directly into the bloodstream. Because of the way they are administered, these products go around the body’s natural defenses against toxins and other dangerous ingredients. The fact that they are injected means they pose additional risks.

Furthermore, if consumers turn to these products that claim to cure or treat serious conditions, they may delay or stop appropriate medical care. Delaying the right care or stopping appropriate treatment can place people at serious and life-threatening risk.

For a drug to be approved by the FDA, it first has to be proven safe and effective.

And none of the homeopathic injectables being marketed by the listed companies has been approved by the FDA. In fact, the FDA hasn’t approved any homeopathic drugs for any use.

The agency strongly recommended that both health care providers and consumers report any issues with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program.