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Nerium AD ®
Safety Panel Presentation

The Nerium Story

 

 


  Safety First
   
 

Overview

The Nerium oleander plant is a fast growing ornamental shrub that contains cardiac glycosides (CG). The Nerium oleander plant is native to Asia and the Mediterranean region. This flowering ornamental plant can be used as borders, hedges, backgrounds, or tall screens and is traditionally grown in yards and on roadways throughout the Southern and Southwestern United States.

Cardiac glycoside - obtained from a number of plants (including the Nerium oleander plant) and used to stimulate the heart in cases of heart failure. In individuals whose heart is not pumping strong enough to push the blood through the body, a cardiac glycoside preparation can help stimulate the heart muscle to increase pumping. Treating heart failure with cardiac glycosides increases the strength and vigor of heart contractions that may help maintain your ability to walk and exercise and may improve the strength of your heart. Treating an irregular heartbeat can decrease the risk for blood clots, an effect that may reduce your risk for a heart attack or stroke. Although many natural substances provide beneficial effects-these same gifts of nature can also be harmful if misused!! This is why clear scientific studies are done to show us how and when to use these fruits of the earth.

The use of plants such as Nerium oleander containing cardiac glycosides for medicinal purposes has been reported in ancient texts for more than 1500 years. The Nerium oleander plant has been used as a beneficial herb for centuries, but due to various components of the plant, it has also been associated with some negative stories.

It has been recognized that, if ingested, the Nerium oleander plant (the stems & leaves) and/or Nerium extracts are consumed or ingested in high enough doses/quantities (Misused!!), it can be toxic. It is known that within the chemistry of the Nerium oleander plant there is oleandrin, a cardiac glycoside.

Well-defined (commercially developed) Nerium extracts of this plant at proper concentrations given orally have potential positive benefit. However, if misused, by ingesting an excessive amount of the extracted compound and/or the Nerium oleander plant's stems and leaves, it can be toxic. Symptoms may include abdominal pain, vomiting and drowsiness, although the human mortality associated with Nerium oleander ingestion is generally very low, even in cases of intentional consumption (i.e. suicide attempts).

Research at leading medical institutions and use of well-defined Nerium oleander plant extracts containing cardiac glycosides administered orally, sublingually, and by injection has come to the point of clinical testing in patients. To date, however, there are only two (2) Nerium oleander plant extracts containing cardiac glycosides (oleandrin) that have been developed and completed testing for safety in a FDA Phase 1 clinical trial in the United States. A third trial is in the FDA regulatory process and is funded. These trials continue to provide additional data for determination of Nerium extract (oleandrin) safety levels.

Skin Application

With ongoing research of the Nerium oleander extracts, the researchers have also discovered that extracts of this plant when used topically (where there are no known toxicity effects) provide for some rather unique skincare applications. With this discovery initial product formulation and safety testing moved forward with multiple human studies on various skin applications. As always, Nerium Biotechnology's first concern is for the safety of those using our Nerium extracts. Therefore, all clinical studies have incorporated safety protocols.

Safety/Clinical Testing

Research for product safety and clinical application was provided for by ST&T Research (Science, Toxicology & Technology). ST&T Research is comprised of a group of prominent scientists, including M.D. and Ph.D. pharmacologists/toxicologist and research product development oriented physicians, scientist, and regulatory compliance specialists which include a legal team specializing in US FDA/FTC/Customs regulations. ST&T Research provides product development, product compliance, regulatory compliance, clinical testing, and information and data for safety and efficacy. In addition, Dr. Robert A. Newman who serves as a scientific advisor to Nerium Biotechnology assisted by providing safety data from previous research and studies, experience from a FDA trial at the University of Texas M. D. Anderson Cancer Center, the analytical method and analysis for the determination of oleandrin (CG) in blood plasma.

Each study's primary end-point was to evaluate the topical test articles containing Nerium oleander extract for safety/toxicity, a) Determine if the Nerium oleander CG metabolites were being absorbed through the skin, b) If so, how much, c) If there was any noticeable blood pressure or heart rate changes, and d) If there were changes in blood chemistry or organ system functions. In addition, subjects were observed for inflammation, rash, or tenderness possibly related to the cream application as allergic response.

The studies utilized blood chemistry and CBC analysis whereby a comparison was made of the participant's baseline results with measurements taken throughout the study. As an example, participant blood samples were taken for baseline, on day one (1) and one hour after cream application, day seven (7), day fifteen (15), and on day thirty (30) of product use. These samples were tested for oleandrin (CG) absorption and accumulation in the blood.

Analysis was non-eventful. The blood analysis showed all subjects within normal ranges, there were no detectable CG's in the blood and no adverse reactions noted. The cardiac glycosides contained in Nerium oleander extracts were NOT ABLE to penetrate the skin at detectable levels in the blood.

Product Testing

When tested in multiple studies over a 3-year period as a topical product, there was not one instance of toxicity based on absorption of NAE-8 (Nerium Extract). All product studies have incorporated safety protocols, including the recent clinical testing of NeriumAD where:

"Subjects were required to provide blood samples for blood chemistries. As in previous studies, no adverse reactions were noted; blood analysis showed all subjects within normal ranges, there were no detectable cardiac glycosides in the blood."

Nerium Biotechnology is confident that you will not only find NeriumAD to be one of the most effective products you have used, but also one of the safest.