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Brachial plexus injuries, also known as Erb’s Palsy, are injuries to the nerves in the shoulder area that usually occur at birth. These injuries, which affect the movement of a child’s shoulder, arm

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

and hand, happen when the infant’s shoulders get stuck in the birth canal after the head emerges (shoulder dystocia), requiring techniques to free the child from the cervix which do not use traction.

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

Examples of combination products may in

If excessive force is used, these measures may lead to significant injury for both mother and child. The pulling of the baby’s head stretches and injures the nerves in the shoulder that is impacted.

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

This collection of nerves is called the brachial plexus or Erb’s Point, which is located in the upper trunk. In most cases these nerves are only stretched, and usually recover spontaneously within 3

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

-4 months. Sometimes, as the nerves try to heal themselves, scar tissue is formed along the nerve that disrupts signals to the muscles. In other instances, the nerves are so severely injured that the

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

Combination pro

y are torn from the spine (avulsed), or they may be ruptured at a different place along the nerve. These situations result in varying degrees of paralysis of the arm and shoulder, and if surgical int

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

ervention is not conducted in a timely fashion, this paralysis may be permanent.

Brachial plexus injury may result in various degrees of weakness. The part of the arm that is involved directly corre

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

ates to the nerves that may be damaged in the upper trunk (generally C5, C6), middle trunk (generally C7) or lower trunk (Klumpke’s Palsy generally C8, T1). Babies with this type of injury will have

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

limp arms by their sides, with forearms turned inward and wrists bent. The affected babies cannot lift their arm, and may also have droopy eyelids (Horner’s Syndrome) on the side that was injured.

I

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

n most cases, brachial plexus injuries are preventable, and it is important for the mother to receive regular prenatal care with dietary vigilance. High blood sugars over-nourish babies and make them

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

gain weight faster than normal, and larger babies are more likely to get stuck in the birth canal. This is why diabetic mothers or mothers with gestational diabetes are more likely to have these hig

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

Following aspects would a

h risk deliveries. Advanced planning with your physician during your pregnancy will help to anticipate a difficult delivery.

The manner in which the baby is delivered may also be a cause of Erb’s Pa

dd to the challenges in developing combination products:

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

lsy, even if there are no prenatal signs. The factors include excessive traction, fundal (stomach) pressure, limited or no episiotomy, and failure to use the appropriate maneuver to free the baby’s

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

shoulder.

Some prenatal risk factors are:
· Mothers with a small pelvis
· Previous history of shoulder dystocia
· Prolonged labors
· Induced labors
· Breech deliveries

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

Fetal malposition
· Mothers with diabetes or gestational diabetes

As a result, a caesarean section may be indicated, but may not always be the first choice of your health care provider. Caesar

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

ean sections have their own inherent complications, such as:
· Hemorrhage
· Infection
· Pulmonary embolism
· Adhesions
· Intestinal obstruction
· Bladder injury
· U

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

Professional from academic institutions, pharmaceutical industries, health care indust

terine rupture
· Higher incidence of ectopic pregnancies (future) and
· Placenta praevia

An informed decision is the best decision for your health and the health of your unborn child.

For

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

more information on helping children with brachial plexus injuries, please refer to the following resources:

National Rehabilitation Information Center (NARIC)
4200 Forbes Blvd
Suite 202<

.

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

br> Lanham, MD 20706-4829

www.naric.com
Tel: 301-459-5900

United Brachial Plexus Network
k
1610 Kent Street Kent, OH 44240

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

Companies that provide selfless information through particip

r> www.ubpn.org
Tel: 1-866-877-7004

Many brachial plexus injuries are the result of medical malpractice and require the services of an attorney

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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