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The FDA recently added black box warnings to the $10 billion a year anemia drugs Procrit, Epogen and Aransep, citing an increased risk of d

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

eath, stroke, heart attack and blood clots. The strong new warnings were added after studies showed a higher risk of death and life-threat

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

Examples of combination products may in

ening side effects in some patients.

These drugs are genetically engineered versions of a natural protein, erythropoietin that increases t

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

e number of red blood cells. They are generally prescribed to patients with kidney disease or cancer in the event that they become anemic.

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

However, patients with chronic kidney failure are sometimes more likely to suffer increased risk of death, blood clots, strokes and heart

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

Combination pro

attacks if prescribed too high a dosage of the drugs. In other studies, patients with head and neck cancer had more rapid tumor growth if

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

they used higher-than-recommended doses. Additionally some studies showed an increased blood clot risk among cancer patients who were not

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

receiving chemotherapy and in patients following orthopedic surgery.

The new boxed warning states that Erythropoiesis-stimulating agents (

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

ESAs) increased the risk of death and serious cardiovascular problems when given at higher than recommended doses. The FDA also suggested

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

hat higher doses of the dangerous drug could lead to blood clots.

Director of the FDA’s Center for Drug Evaluation and Research, Steven Ga

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

lson said “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent c

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

Following aspects would a

linical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to

dd to the challenges in developing combination products:

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

all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Commi

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

ttee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”

The recent stern warnings will advise physic

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

ians to prescribe the lowest possible doses of the EPAs that prevent blood transfusions. Previously, in dialysis patients, doctors would a

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

m for a near normal level of hemoglobin. That required greater amounts of drugs, but it has now been shown to also cause a greater inciden

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce of side effects.

Dr. Eric P. Winer, chief of the breast cancer center at Dana-Farber Cancer Institute in Boston said that “these drugs

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

have been somewhat overused. I don’t think it’s been without some effort on the marketing end. There has been a tendency I think for pati

.

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

nts, and to some extent health providers, to attribute more fatigue to anemia than deserves to be attributed.”

If you or a loved one has b

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

Companies that provide selfless information through particip

een prescribed one of these defective drugs for anemia, we suggest that you consult your primary care physician in light of recent findings

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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