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Subject:
From:
"Frank J. Nice" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Fri, 12 Jan 2018 17:16:33 +0000
Content-Type:
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Re:

"I work at a hospital in Washington, DC and had a discussion with the radiologists about this. They understand the literature from ACR, but one radiologist pointed out that the actual package instructions that accompany Omnipaque, a frequently used contrast media, are not as explicit. The instructions state:

Nursing Mothers
It is not known to what extent iohexol is excreted in human milk. However, many injectable
contrast agents are excreted unchanged in human milk. Although it has not been established
that serious adverse reactions occur in nursing infants, caution should be exercised when
intravascular contrast media are administered to nursing women. Bottle feedings may be
substituted for breast feedings for 24 hours following administration of OMNIPAQUE.

Unfortunately, until the packaging materials are more explicit, radiologist pay prefer to operate in CYA mode. If something did happen to the infant and a mother received contrast media, not sure radiologist would be legally covered if he advised mom to continue breastfeeding, even in light of ACR recommendations."

Alex Walker, BSN, RN, IBCLC


This is what really is known at this point:


Non-ionic Iodinated Contrast Media

Iodinated contrast media is a contrast media containing iodine that is used in radiography to increase the clarity of the image. Iodinated contrast media can be divided into the two groups: ionic and non-ionic. Each group varies in their uses, properties and toxic effects. In non-ionic iodinated contrast media the iodine is bound to an organic (non-ionic) compound and has a low osmolality

Based on kinetic data, the American College of Radiology suggests that it is safe for a mother to continue to breastfeed after receiving  ionic iodinated contrast media


The conundrum is this:

Past FDA lactation labeling guidelines did not require the labeling information to include what I present above because if the manufacturer did include this information in its labeling, it an d the healthcare practitioner would open themselves up automatically to malpractice suits to any possibility of misuse or misinformation provided to the breastfeeding patient.  Current FDA lactation labeling will allow the inclusion of this data and information.  Then, anyone using the product under FDA lactation labeling would not be open to sue the drug manufacturer or practitioner for following FDA lactation labeling guidelines.

What is really unfortunate is that healthcare practitioners do not know good standard medical practice that includes doing a complete benefit-risk analysis based on all the drug information available plus kn owing the benefits of breastfeeding and the risks of using artificial formula.

That is where it our jobs to educate our fellow healthcare practitioners to all aspects of breastfeeding and just what information is out there.

It is truly unfortunate when we do not do it or are afraid to do it.

As I tell my students: pharmacy is 1/2 knowledge, 1/2 detective work, and 1/2 common sense.

I am sure if the hesitant radiologist used all the information I suggest to make a decision, and documented it, it would be considered to be good standard medical practice, and legal, and legally covered.


Frank J. Nice, RPh, DPA, CPHP






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