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There are millions of women around the world who are using birth control pills as an effective way of avoiding becoming pregnant. Also some women and young girls who take the birth cont

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

rol pill do so as a way to help with irregular periods or deal with other health problems they may have such as acne. But it is important that every woman understand the high blood press

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

Examples of combination products may in

re birth control pills connection to ensure they manage the potential dangers of hypertension.

First lets cover a little bit about birth control pills and how they work. The most commo

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

ly used birth control pills are made from a synthetic mixture of two hormones (estrogen and progesterone). However there is one particular type of birth control pill, which contains jus

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

t the synthetic hormone progesterone and this is more commonly known as the mini pill.

The pill works by fooling the body into thinking it is pregnant and so suppressing the hormones th

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

Combination pro

t trigger ovulation. They also reduce the development of the uterus lining and increase the amount of mucous in the cervix, making it harder to sperm to navigate its way to its target.

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

he hormones in the contraceptive pill that do a great job at fooling the body, are also synthetic replicas of our own hormones, and are the ingredients that increase the risk of a women

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

having high blood pressure.

The studies that have been carried out in the past have shown that contraceptive pills can elevate blood pressure levels, but since many of those studies the

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

levels of hormones used in contraceptive pills have been reduced.

However, there is still a greater risk of hypertension in those that take contraceptive pills compared to their peers w

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

o don’t, and so this is why a doctor will take certain precautions when prescribing them.

The level of increase in blood pressure of someone who takes the contraceptive pill can range f

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

om nothing/ mild, to severe with only a few factors that have been identified as potentially increasing the risk; these include:

- Having a family history of high blood pressure especia

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

Following aspects would a

lly on the female side
- Having a history of high blood pressure during pregnancy
- Having a heart or blood vessel condition

Also, the risk of elevated blood pressure seems to

dd to the challenges in developing combination products:

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

increase with age, length of usage and body mass.

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When a women f

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

rst decides to start taking a contraceptive pill she will usually have a baseline blood pressure reading taken. This is so if there are marked changes to the blood pressure levels they

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

can be identified when future readings are taken. To be sure there are no adverse effects the doctor is likely to request a new user to revisit every few weeks to initially monitor any

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

otential impacts on blood pressure.

When requesting a repeat prescription a doctor or nurse will again take blood pressure measurements to ensure there is no abnormality in blood pressu

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

Professional from academic institutions, pharmaceutical industries, health care indust

e readings.

If blood pressure levels have risen then there are a few options available to the doctor, including;

- Allowing continuation with the contraceptive pill alongside close mon

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

itoring
- Discontinue the use of the contraceptive pill and try another contraceptive option
- Switch to another contraceptive pill and monitor the reaction.

Although there is

.

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

a recognized High Blood Pressure Birth Control Pills link, there have been few recent studies that allow for an understanding of the complete risk. All that is known is that each person

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

Companies that provide selfless information through particip

may react differently to taking contraceptive pills and close monitoring of blood pressure is required initially, followed by regular blood pressure checks throughout the course duration

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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