Advice Pool - Health and Fitness

The most appropriate answer to the question whether Hoodia is safe, to be honest, cannot be answered one way or the other. The simple reason for this is that scienti

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

fic research has not been undertaken on a wide enough scale yet to establish conclusively its long term or short-term effects.

Hoodia gordonii is a cactus-like succ

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

lent plant that grows only in the regions in and around the Kalahari Desert of South Africa. It contains an active appetite-suppressing molecule by the name P 57. Ph

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

topharm, which holds the exclusive rights on hoodia gordonii, its production and the sale of its products containing P 57, in collaboration with Unilever, which has

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

tie-up with Phytopharm, has been conducting clinical studies on the appetite suppressant properties of hoodia gordonii. But it has not yet come out with any authent

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

c results about hoodia’s side effects. To know the long-term or the short-term side effects of the plant in general or its active molecule P 57 in particular, scient

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

sts need to carry out extensive research over long periods of time on a wide enough scale covering large numbers of people. This has not been possible so far, given

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

he short history of the growing popularity of hoodia gordonii.

Certain succulent plants like aloe vera are considered unsafe for pregnant women. Aloe vera is used i

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

cases of amenorrhea, on order to increase menstrual flow. Hoodia gordonii is also a succulent plant, but no one knows for certain whether it is, like aloe vera and

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ome other similar succulents, unsafe for pregnant women. Hoodia may be unsafe for diabetics as well, although clinical studies on this aspect have not been performed

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

There is no doubt that hoodia gordonii is an appetite suppressant. But one should bear in mind that most appetite supplements contain some stimulant or the other.

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

It is a fact that any stimulant increases the heart rate or blood pressure. If you ask whether hoodia too increases the heart rate or blood pressure, scientists will

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

certainly say that the research done so far does not indicate any such side effect, however, it lacks the intensive research that many other drugs have had. On the o

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

her hand, Hoodia is all natural and must be considered safer than other appetite supplements that contain stimulants.

The market is full of high-priced but low- eff

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ct hoodia products. Many of the so-called hoodia gordonii supplements may contain more of ephedrine or ephedra or ma huang, which are the usual ingredients in popula

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

dietary supplements, and less of the authentic hoodia gordonii, especially the part that has P 57. The authenticity of these products claiming to be the real hoodia

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

gordonii but without any supporting certification is naturally questionable. Therefore, you cannot be sure of such hoodia gordonii products being safe.

You can perh

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ps consider genuine and pure hoodia gordonii as safe. It is not a stimulant and is not known to produce any side effects, at least in the short term. Ensure, therefo

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e, that you buy only that hoodia gordonii that is CITES certified. It should also carry the Analytical Report as well as the license from the Western Cape Conservati

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

n Authority of South Africa. As long as there are no documented data proving that Hoodia is unsafe, you can assume it is safe to use pure and genuine hoodia gordonii

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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