其 他 安 全 警 示
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| The United States: FDA warns four manufacturers of unapproved injectable drugs labeled as homeopathic (English only) |
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The US Food and Drug Administration (FDA) announces that it has issued warning letters to the following four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law. The affected products are:
- Hervert Pharmaceuticals, LLC: Arnica, Calmvalera comp, Gelsemium comp, Hepar comp, and Lymphaden comp
- MediNatura, Inc.: Zeel Injection Solution, Traumeel Injection Solution, Engystol Injection Solution, Neuralgo Rheum Injection Solution, Lymphomyosot X Injection Solution and Spascupreel Injection Solution
- 8046255 Canada, Inc., doing business as Viatrexx: Articula, Mesenchyme, Connectissue, MuSkel-Neural, Ouch, Ithurts, Adipose, Systemic Detox, Hair, Neuro 3, Infla, Collagen, Prolo, Lymph 1, GI, Neuro, Arthros, Male+, Immunexx, Relief+, Intra-Cell, Facial and ANS/CNS
- World Health Advanced Technologies, Ltd.: Enercel Plus and Enercel Plus IM
FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic 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. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labeled uses, and FDA has not approved these products. Some drugs, such as Enercel, marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C. 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). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-warns-four-manufacturers-unapproved-injectable-drugs-labeled-homeopathic
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Viatrexx.
Ends/Wednesday, Jun 17, 2020
Issued at HKT 15:00
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