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NSF/NFD (nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy) is a painful and debilitating condition which involves hardening of the skin and

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

can cause damage to internal organs. It is caused by the use of gadolinium, used in MRI’s and MRA’s, in patients with kidney disease.

NSF/NFD was first di

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

Examples of combination products may in

scovered in 1997. So far it appears that only people with kidney disease develop the condition. It is rare, but very difficult to treat, and can be very pai

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

nful, debilitating, and sometimes fatal. It is also preventable.

Gadolinium is a contrast agent used in magnetic resonance imaging (MRI) and magnetic reson

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

ance angiography (MRA). A contrast agent is a dye which is injected into your body to enhance the images. Iodine-based contrast agents are known to cause ac

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

Combination pro

ute renal failure. Gadolinium is supposed to be much safer, but in patients with kidney disease, it appears to be causing NSF/NFD.

NSF/NFD Symptoms
NS

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

F/NFD can take days or week to develop. If the condition progresses rapidly, it can be fatal.

Symptoms include:
· Tightening and swelling of the skin,

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

usually in the extremities, sometimes in the trunk of the body
· Thickening of the skin around the joints, restricting movement
· Red patches on t

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

he skin
· Skin which feels “woody” with texture similar to that of an orange peel
· Burning, itching, and/or sharp pains in affected areas
·

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

Calcification of soft tissues
· Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
· Muscle weaknes

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

s
· Deep bone pain in the hips and ribs
· Yellow plaques near the eyes
· Fluctuating hypertension preceding the appearance of skin legions

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

Following aspects would a

>

Why Gadolinium contributes to NSF/NFD in people with kidney problems Free gadolini

dd to the challenges in developing combination products:

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

um is very toxic, but when used in as contrast agent it is bound to a chelate to make it safe for human use. It is removed from the body by the kidneys. Whe

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

n your kidneys aren’t functioning properly, you are left with high levels of gadolinium in your system.

Treating NSF/NFD Currently there is no cure for N

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

F/NFD, and it usually does not respond to treatment, but some patients experience partial or full recovery. Improving kidney function can slow or stop the

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

progression of the condition, and for some can even mean an improvement in symptoms. This can involve a kidney transplant. Other treatment options include:

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

Professional from academic institutions, pharmaceutical industries, health care indust

· Oral steroids
· Topical Dovonex
· Ultraviolet therapy
· Extracorporeal photopheresis (ECP)
· Plasmapheresis
· Thalidomide

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

r> · Pentoxifylline (PXF)
· Plaquenil
· Physical therapy
Each patient responds differently to different treatment options and some of the op

.

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

tions above have serious side effects and/or cannot be used long term.

If you believe you have developed NSF, we strongly advise you to contact your physic

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

Companies that provide selfless information through particip

ian for an examination which may involve a skin biopsy. If you are diagnosed with NSF, you should consult with an experienced pharmaceutical injury attorney

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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