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The Atria of the heart are responsible for processing both arterial and venous blood with one atrium responsible for the blood to the arteries and the other atriu

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

m responsible for the blood coming in from the veins. In order to prevent the mixing of these two blood groups (which could have consequences on the overall maint

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

Examples of combination products may in

nance of the body) the heart has evolved a wall between the two atria.

This wall, known as the interatrial septum or sometimes simply just the septum, is respons

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

ible for regulating blood flow and preventing arterial and venous blood from mixing with each other. In a baby before birth, the lungs are too poorly developed to

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

constantly ensure well oxygenated blood traveling through the developing fetus and as such the mother’s lungs are largely responsible for ensuring that the baby f

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

Combination pro

etus receives well oxygenated blood up until their birth.

To facilitate this and allow venous blood direct access to the circulatory system, the interatrial sept

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

m does not develop fully until very close to childbirth as at that point in human development it would be counterproductive to do so. This septum, however, is nec

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

essary in any human that has developed beyond the pre-birth stage. The lack of an interatrial septum or the lack of a fully developed one is known as an atrial se

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

tal defect (people in this condition sometimes also are referred to as having ahole in heart) and this type of defect can cause pulmonary hypertension as well as

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

result in some blood pressure complications at later stages of life, making it a potentially big problem.

Where Paxil Comes In

In late Septembe

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

of 2005, the FDA strengthened its warning on Paxil and the risk of birth defects was added to the label of the drug, warning all pregnant women that taking the d

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

Following aspects would a

rug could result in birth defects such as their child being born with a hole in heart defect. Paxil is a drug used by people of all kinds in order to help them wi

dd to the challenges in developing combination products:

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

h conditions like clinical depression, anxiety, stress, obsessive compulsive disorder and panic attacks.

The problem with pregnant women taking the drug is that

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

it can cause birth defects (some which are quite severe) and as a study released in December of 2005 showed, pregnant women that took Paxil were much more likely

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

o give birth to a child that was born with some kind of defect. The study was a double-blind experiment (which meant that none of either the control group of wome

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

n or the study group of women was aware of which procedure they were following in the study) and the difference was severe enough to be statistically significant.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Paxil has been linked to many different birth defects and the atrial septal defect is just one of them.

A baby born with an atrial septal defect can experience a

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

wide range of symptoms because of it, many of which will cause physical pain to the child. The best way to avoid your child potentially being born with an atrial

.

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

septal defect due to use of a drug like Paxil is to simply avoid taking any drugs like Paxil during your pregnancy. If this is not possible, consult your physicia

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

Companies that provide selfless information through particip

n and do not deviate from the advice they give you. Doing so could mean the difference between a healthy child and one with a defect such as the atrial septal one

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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