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Did you know there’s a new product on the market that enables you to test you breast milk for the presence of alcohol? And did you know that it’s completely unnecessary?

Designed by two m

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

oms, Milkscreen works as follows: Saturate the test pad with some breast milk, wait two minutes, and if the pad changes color, voila! Alcohol is present in your milk. This information is

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

Examples of combination products may in

supposed to help you decide whether or not it’s “safe” to nurse after having had that beer on a hot summer night.

So what’s the problem?

When it comes to alcohol, there’s a huge differen

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

ce between getting roaring drunk and having an occasional glass of wine. Milkscreen does not differentiate. Either there’s alcohol in your milk, or there’s not. The results are the same w

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

hether you had a single glass of champagne, a full six-pack, or even a dose of NyQuil.

Experts agree that drinking alcohol in moderation is not incompatible with breastfeeding. “Prohibiti

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

Combination pro

ng alcohol is another way we make life unnecessarily restrictive for nursing mothers,” asserts Dr. Jack Newman, author of numerous books and articles on breastfeeding and a member of the LL

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

LI Health Advisory Council. And the more rules associated with breastfeeding, the less likely they will nurse, adds lactation consultant Amy Spangler. “Mothers need to trust themselves,” S

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

pangler says. “They don’t need to test their milk.”

Women take plenty of over-the-counter and prescription medication and continue to safely nurse their children. Even smokers are encour

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

aged to nurse because in spite of the presence of nicotine in their milk, their own milk is still preferable to formula. And why the obsession of breast milk safety in the first place? A

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

s lactation consultant Linda Smith asserts, “Nobody is marketing a test for the safety of formula!”

Formula remains a far more risky choice than good old-fashioned breast milk. In her fas

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

inating and provocative book, Having Faith: An Ecologist’s Journey to Motherhood, biologist Sandra Steingraber presents a frightening assessment of the degree to which traces of pesticides

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

Following aspects would a

and toxic chemicals are found in the breast milk of women all over the planet. Yet Steingraber remains a staunch proponent of breastfeeding and indeed nursed her own children for several

dd to the challenges in developing combination products:

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

years each. Why? Because formula is still riskier than breast milk, even when that that milk has traces of alcohol in it. “We spend an awful lot of time balancing small theoretical hazar

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

ds of breast milk against actual hazards of formula,” asserts lactation consultant Diane Wiessinger.

A Balanced View

I’m not trying to be cavalier about alcohol. Excessive drinking can a

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

ffect your baby’s ability to nurse effectively and can inhibit milk production, as well. But experts agree that drinking in moderation is not incompatible with breastfeeding. And a little

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

judgment and common sense are at least as effective as a simplistic test. Are you drinking on an empty or full stomach? (Food decreases the absorption of alcohol.) How much will you be

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

Professional from academic institutions, pharmaceutical industries, health care indust

drinking? (The more you feel the affects, the more your baby will; the more you drink, the longer it will take for the affects to wear off.) How do you metabolize alcohol? (Heavier peopl

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

e can metabolize alcohol more quickly than lighter folks.) Finally, how old is your baby? )A newborn’s liver is immature and he will feel the effects of alcohol more than an older baby.)

.

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

The bottom line? If you drink a lot, don’t nurse. And seek help. Heavy drinking will affect your mothering ability in more areas than breastfeeding. But breast milk is rarely a dangero

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

Companies that provide selfless information through particip

us substance from which babies need protection. “If a mother is so drunk that she’s at risk of dropping the baby,” asserts lactation consultant Linda Smith, “she needs help with the baby!

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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