Advice Pool - Health and Fitness

Oftentimes, when fibromyalgia is diagnosed, people are prescribed medications to treat pain and other symptoms associated with the disorder. But recent studi

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

es have shown that there may be a fibromyalgia high blood pressure link and certain medications may even put a patient at risk.

Serotonin, fibromyalgia and

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

Examples of combination products may in

igh blood pressure

Serotonins are neuro-transmitters that pass on messages from one cell to the next via synapses. In the central nervous system, serotonin

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

affects memory, mood and sensations of pain. A condition called Serotonin Syndrome is characterized by increased serotonin levels in the body.

For people wh

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

have fibromyalgia, serotonin syndrome can become a problem. Some of the newer and most promising treatments for fibromyalgia are serotonin-based medications

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

Combination pro

These medications provide relief from pain and muscle stiffness but they can also elevate the levels of serotonin in the body. As a result, fibromyalgia pat

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

ients can feel dizzy, restless, confused, uncoordinated, sweaty and anxious.

If left untreated, this syndrome can lead to complications including high blood

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

pressure. If allowed to progress, high blood pressure as a result of fibromyalgia medication can be life-threatening and lead to seizures and strokes.

High

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

blood pressure as a result of fibromyalgia

In a recent study conducted by the School of Medicine and Public Health at the University of Wisconsin, it was f

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

und that fibromyalgia increases the risk developing metabolic syndrome. Metabolic syndrome brings with it a host of risk factors that include stroke and high

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

blood pressure.

In the study that involved 109 women who have fibromyalgia, it was found that they were 5.5 times more likely to develop metabolic risks tha

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

Following aspects would a

n women who were healthy are. They also tended to have higher body mass index, LDL cholesterol levels, glycosylated hemoglobin and yes, high blood pressure.

dd to the challenges in developing combination products:

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

Changing the way we treat fibromyalgia

The American Heart Association recently made a statement regarding the use of certain drugs to treat chronic pain, in

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

cluding those associated with fibromyalgia. According to the statement, the AHA advises doctors to use treatments that are non-pharmacologic as a first line

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

f defense against fibromyalgia. Only when this approach fails should doctors consider medications to provide relief but only in a 'stepped-care' approach. Th

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

AHA believes that chronic pain, including fibromyalgia pain, can be overcome without the need to expose patients to risks such as heart problems and high bl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood pressure.

For more information about how to treat fibromyalgia symptoms naturally and without side effects sign up for the newsletter below.

Due to the

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

side effects of certain medications, fibromyalgia is often inadvertently linked to high blood pressure. Because of the accompanying risks involved, patients

.

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

must work closely with their doctors to find the proper medications that can treat their disorder and still keep the negative risks low. Patients should be

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

Companies that provide selfless information through particip

ware of the fibromyalgia high blood pressure connection so they know what to expect and to see their doctor immediately if a negative reaction is experienced

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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