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E-Articles - Obesity - Its Serious Complications On Pregnancy
Obesity is the major contributing factor for rising complications in pregnancy and is a major nutritional disorder. For a scale, if the BMI of
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
the pregnant mother, in the initial stages of pregnancy, is above 25 units, she is considered to be obese.
Obesity is one of the most common b
Obesity is one of the most common b
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ut a major nutritional disorder. Unfortunately, the scores of complications, leading to irrevocable damages to the body systems, which are brou
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ht upon by obesity are not realised until it is too late to correct.
It is difficult for obese women to conceive because fat tissues surround
It is difficult for obese women to conceive because fat tissues surround
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the uterus and ovaries , rendering fertilization difficult. The fat content creates harmonal imbalance causing difficult cycle and difficult c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nception.
There are various factors leading to weight gain / obesity during pregnancy.
a. Weight at the initial stages of pregnancy.
There are various factors leading to weight gain / obesity during pregnancy.
a. Weight at the initial stages of pregnancy.
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
b. Less physical activity / exercise
c. Intake of excess calories.
d. Genetic factor.
e. Size of placenta
f. quanti
c. Intake of excess calories.
d. Genetic factor.
e. Size of placenta
f. quanti
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
ty of amniotic liquid.
g. Liquid retention.
Complications:
a. High risk of misconception
b. Baby can be born with compli
g. Liquid retention.
Complications:
a. High risk of misconception
b. Baby can be born with compli
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ations
c. May result in caesarian delivery.
d. Mother can develop diabetes
e. Leads to conditions including pre-eclampsia whi
c. May result in caesarian delivery.
d. Mother can develop diabetes
e. Leads to conditions including pre-eclampsia whi
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
ch is life-threatening symptom, affecting both the mother and child.
f. Urinary infections are very frequent.
g. High risk of com
f. Urinary infections are very frequent.
g. High risk of com
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
lications rises.
h. Obese women could contract serious diseases of Arterial hypertension, altered cardiac function.
i. Long term c
h. Obese women could contract serious diseases of Arterial hypertension, altered cardiac function.
i. Long term c
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
omplications viz. worsening of maternal obesity and development of obesity in the infant. ( which has a greater involvement in geneteic factors
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
leading to child obesity )
j. Hypertension, due to obesity, is responsible for increased morbidity during pregnancy.
k. Mean diast
j. Hypertension, due to obesity, is responsible for increased morbidity during pregnancy.
k. Mean diast
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
lic pressure is higher in children of women who were obese during pregnancy.
l. Obesity during pregnancy is a strong predictor of sustai
l. Obesity during pregnancy is a strong predictor of sustai
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ned weight retention, after pregnancy also.
m. When diabetes complicates the course of pregnancy, childhood obesity and overweight are the
m. When diabetes complicates the course of pregnancy, childhood obesity and overweight are 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
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
resultant factors to face.
It is of paramount importance that strict Nutritional, caloric and vitaminic care should be taken during pregna
It is of paramount importance that strict Nutritional, caloric and vitaminic care should be taken during pregna
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ncy. Non adherence will surely lead to serious health complications to both mother and the child.
Overweight is a risk factor for impairment
Overweight is a risk factor for impairment
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
of carbohydrate tolerance, both in non-pregnant and during pregnancy stages.
Reference Books / Publications: 1. Obesity is one of the common
Reference Books / Publications: 1. Obesity is one of the common
.
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
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
nutritional disorders- Divya Sood- Director-Naturopathy- on how obesity can affeect pregnancy. Indian Express- September-1, 2006
2. AM J Obste
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
t Gynecol 1985:152 : 238-45 (Medicine)
3. Abrams B, Parker J. Overweight and pregnancy complications. Int. J.Obes 1988: 12:293-303 (medicine
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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