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WHY YOU SHOULD BE CONCERNED ABOUT YOUR NEWBORN IF YOU USE PAXIL

Expectant mothers once took prescription medication, drank alcohol (moderately) and s

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

moked cigarettes, as well as illegal drugs…all while they were pregnant. None of these activities were seriously frowned upon (except for the illegal

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

Examples of combination products may in

rugs of course) until years and years of research had been gathered. Then these seemingly harmless activities were linked to any number of birth defec

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

ts. Well now it’s happened again. A once harmless drug, after years and years of research, has been transformed into a leading link possibly contribut

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

ng to Persistent Pulmonary Hypertension of the Newborn (PPHN). And this decade’s prescription drug of choice is…Paxil.

In a recent study released fro

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

Combination pro

m the Federal Drug Administration (FDA), a fetus whose mother uses the drug during the first trimester is six times more likely to develop PPHN than t

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

e general population (those not taking Paxil). But for women who have taken the drug for a considerable amount of time may be causing the baby more ha

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

rm by stopping the use of the drug, than good. Why? To answer that question you need a better understanding of what Paxil is in the first place.

PAXI

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

AND WHY IT’S SO POPULAR

Paxil (medical name: paroxetine) is the most common and heavily prescribed antidepressant on the market. Since 1992, when Pa

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

xil first hit the market, doctors and patients have turned it into one of the most successful prescriptions antidepressants in history. Doctors regula

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

ly prescribe it to patients suffering from depression, panic attacks and phobias. It was also the first drug to be heavily prescribed to patients who

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

Following aspects would a

suffer from shyness. Patients who have used Paxil for years sometimes find it hard to survive in the everyday world without it. This includes women wh

dd to the challenges in developing combination products:

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

are pregnant or who are thinking of getting pregnant.

PAXIL LINKED TO PPHN

However, studies from other medical institutions and publications have c

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

onfirmed the FDA report that Paxil could be a leading contributor to Persistent Pulmonary Hypertension of the Newborn. PPHN’s symptoms include, but ar

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

not limited to:

• shortness of breath or other kung defects

• peripheral edema (swelling of the limbs, especially around the ankles and feet)

• he

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

art defects

WHAT’S BEING DONE

The FDA has asked the makers of Paxil to switch the warning on the label from a “C” to a “D” (meaning the risk to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

etus has been witnessed in clinical trials). The makers of Paxil are still performing their own studies in an effort to show the benefits Paxil provid

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

es a patient outweighs the potential danger to the fetus.

So, as you can see, being able to function in the world (the positive uses of Paxil), and t

.

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

e risk to an unborn child are diametrically opposed forces in this issue. Weighing the positives against the negatives is one of the reasons the FDA h

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

Companies that provide selfless information through particip

as issued a warning about the potential side effects of Paxil. Now it’s up to the consumer to decide if the risk is something they are willing to take

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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