Summary - Health and Fitness

What is Stevens-Johnson Syndrome? Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are life-threat

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

ening conditions. Although infrequent, these conditions kill or severely disable previously healthy peopl

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

Examples of combination products may in

e. (Roujeau, 1995) Both diseases are characterized by rapidly expanding rashes, often with atypical (flat

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

, irregular) target lesion, and involvement of the mucous membranes (mouth, eyes, and genital areas).

Ri

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

sk of getting Stevens-Johnson Syndrome

Females appear to be twice as affected by SJS and TEN than males.

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

Combination pro

Children taking NSAIDs (Motrin, Advil) and anticonvulsants have recently been reported to have an increa

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

sed risk of SJS and TEN. (Mockenhaupt, et. al. 2003; Lesko, et. al. 1995.)

Causes of Stevens-Johnson Syn

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

drome

Drugs cause over 80% of all cases of SJS / TEN. However, 90-95% of TEN cases are caused only by me

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

dications. While there have been very rare reports of infections causing SJS and TEN, most of those case

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

reports were published long before scalded skin syndrome and Toxic Epidermal Necrolysis were distinguishe

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

by biopsy, making these cases more likely to have been caused by a drug.

NSAIDs

Have recently been rec

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

Following aspects would a

ognized by the scientific community to be one of the leading causes of SJS and TEN. A recently published

dd to the challenges in developing combination products:

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

study reported significantly increased risk for ibuprofen in an epidemiologic study published in 2003. (M

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

ockenhaupt, et. al. 2003; Lesko, et. al. 1995.) Anti convulsants and antibiotics are the other leading ca

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

uses of these diseases.

Treatment and Outcomes of patients with Stevens-Johnson Syndrome

Obviously, 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

identification of the responsible drug is important so that the causative drug can be withdrawn or the p

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

Professional from academic institutions, pharmaceutical industries, health care indust

erson can be instructed to stop taking it. One study has shown that the mortality rate can be reduced by

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

30% every day by stopping the drug responsible for the reaction. (Garcia-Doval, 2000) The care of patient

.

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

s with SJS and TEN usually requires that they be placed in a burn unit, which is a highly specialized uni

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

Companies that provide selfless information through particip

t that cares for burn victims with the 2nd and 3rd degree burns that SJS and TEN causes all over the body

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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