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Are you trying to decide whether or not to have your baby boy circumcised? Circumcision is fairly common in the United States. It involves the surgical removal of the skin

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

covering the tip of the penis. For some parents, circumcision is a religious ritual. For other parents circumcision is to help with personal hygiene or preventive health ca

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

Examples of combination products may in

e. Still yet other parents feel the procedure seems unnecessary.

In this article, review the pros and cons of having your baby boy circumcised. There are benefits and nega

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

ives to the procedure. The American Academy of Pediatrics says the benefits are not strong enough to recommend routine circumcision for all male newborns. The decision is l

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

ft up to the parents. They also support use of pain relief for infants who have the procedure. The benefits of circumcision may include:

• Easier hygiene: Circumcision ma

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

Combination pro

make it easier to wash the penis. It is simple to clean an uncircumcised penis as well.
• Decreased risk of urinary tract infections: Risk of urinary tract infections

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

in the first year may be decreased. Urinary tract infections may be up to 10 times as common in uncircumcised baby boys. Severe urinary tract infections early in life can l

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

ead to kidney problems later on.
• Decreased risk of penile cancer: Cancer of the penis is very rare. It is less common in circumcised men.
• Decreased risk of se

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

ually transmitted diseases: Circumcised men may have a slightly lower risk of certain sexually transmitted diseases that includes HIV which causes AIDS, and HPV which causes

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

genital warts.

The negatives of circumcision may include:
• Surgical risks: Excessive bleeding and infection are uncommon, but possible. Foreskin may be cut too s

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

ort or too long to heal properly. Sometimes the remaining foreskin reattaches to the end of the penis and minor surgery may be needed to correct it.
• Pain: Circumcisi

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

Following aspects would a

n is painful. Local anesthesia blocks nerve sensations during the procedure.
• Permanence: After the circumcision it may be impossible to re-create the appearance of a

dd to the challenges in developing combination products:

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

uncircumcised penis
• Expense: Insurance companies may not cover the cost of circumcision.

Circumcision care:

It takes about seven to 10 days for the penis to heal.

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

There may be a noticeable yellowish mucus or crust. A small amount of bleeding is common the first day or two. Daily care includes:

• Washing the penis as it heals
•

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

Change the bandage with each diaper change
• Apply a small amount of petroleum jelly to the tip of the penis so it won’t stick to baby’s diaper.

Although problems after

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

circumcision are rare, you should call your doctor if:

• Baby does not urinate normally within six to eight hours after the circumcision
• Persistent bleeding or rednes

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

Professional from academic institutions, pharmaceutical industries, health care indust

around the tip of the penis
• Tip of penis is swollen
• You suspect an infection. An infection may manifest as a foul-smelling drainage from the tip of the penis

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

or crusted sores filled with fluid.

Source: Mayo Clinic

Disclaimer: This article is for educational purposes only. It is not intended to be a substitute for informed me

.

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

ical advice or care. You should not use the information in this article to diagnose or treat any health problems or illnesses without consulting your pediatrician or family

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

Companies that provide selfless information through particip

octor. Please consult a doctor with any questions or concerns you might have regarding your or your child’s condition.

This article is FREE to publish with the resource box

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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