Confused, AAP/FDA

[alleyoop]

Can someone clear this up for me? I hear all the time about this AAP approved drug and that one. When did the AAP get in the business of approving drugs? I thought that FDA was our agency for reviewing medications!

This question became very topical for us regarding Domperidone. My LC said that it was approved by the FDA. After doing my own research before having the drug compounded I found out she lied to me. What a wake up call that LCs are NOT DOCTORS!! It isn't approved for increasing supply by the FDA. So, is the AAP in the business of overriding the FDA? Does the doctor/pharmacist look over the AAP "approvals" before administering? And who is the AAP accountable to? The FDA?

HELP! I am so confused!

[JElaineB]

I don't really understand the whole AAP "approval" thing myself, I think it is more of a "recommendation" from them. The FDA is the US agency that regulates and approves drugs. With domperiodone (Motilium), the fact that this drug is approved in other countries (like Canada and New Zealand) and that it is available in US compounding pharmacies and that it has few side effects, AND that the AAP recommends it would make me feel very safe taking this drug. If I had known it was available at compounding pharmacies when I was having breastfeeding problems I *would* have taken it (sadly, I knew about this drug but neither my LC nor apparently my OB knew it was readily available in this country, I thought it had to be ordered from a foreign country in a gray market area). My OB was willing to prescribe Reglan but I did not want to take it because of the possibly nastier side effects (and Reglan is FDA approved). Also note that many doctors prescribe FDA approved drugs all the time for off-label use. As long as the drug is FDA approved the doctors can do whatever they want with it, basically.

You may have seen these pages, but here are some website specifically talking about domperidone:

http://www.bfar.org/domperidone.shtml
http://www.breastfeedingonline.com/domperidone.shtml
http://pregnancy.about.com/cs/breastfeedinginfo/a/aanho19.htm?terms=domperidone

Jennifer
mom to Jacob 9/27/02

[malie]

It's not uncommon for doctors of any type to write prescriptions for drugs for what can be considered off-labeled use (perhaps uncommon is not the correct word..maybe it's better to say it's not illegal).

http://aappolicy.aappublications.org/cgi/content/full/pediatrics;110/1/181

"The practitioner who prescribes a drug is responsible for deciding which drug and dosing regimen the patient will receive and for what purposes. This decision is made on the basis of the information contained in the drug’s label or other data available to the prescriber. The off-label use of a drug should be based on sound scientific evidence, expert medical judgment, or published literature. New uses, doses, or indications will not be approved by the FDA until substantial evidence of safety and effectiveness for that indication or age group is submitted to the FDA. This may take years or may never occur, because until recently, there has been little incentive for manufacturers to conduct trials and submit data for new uses in pediatric patients". In other words once a drug is approved for one use even if it is found to be beneficial for another unless the maker of the drug starts a new clinical trial and seeks approval from the FDA that use will never be listed on the product packaging

Personally I think if you go to the AAP you would be hard pressed to find anything anywhere that says they "approved" a drug in the same way the FDA approves a drug. You may however find literature they will site on studies that have been done to suggest different uses of drugs and also whether drug a, b or c appears to be safe for use by woman who breastfeed. Domperidone for example is on a list of drugs that appear to have no ill side effects on children when used by woman who breastfeed. And different studies have been published in recent medical journals http://www.cmaj.ca/cgi/content/full/164/1/17 for one example. That doesn't mean that there is a policy stated somewhere that the AAP approved domperidone to increase milk supply. That doesn't mean there is even a statement that says they have endorsed the use. (And really I think most of the statements from the AAP are endorsements when they come out)

Anyway I think that the use of the word approval is part of the issue here and that the FDA approval is different from any approval or endorsement or suggestion from other sources

[COElizabeth]

The article listed below is by Dr. Thomas Hale, a pharmacologist who is widely considered "the" authority on medications and breastmilk. It doesn't really answer your question on the FDA/AAP question, but it does provide good information on the factors that should be considered in deciding whether a medication is appropriate for a nursing mother.

http://www.mothering.com/12-0-0/html/12-4-0/bfeeding-medications.shtml

Also, the AAP does not have the authority to determine whether a drug can be legally sold in this country; the FDA does. However, as Dr. Hale mentions, for legal reasons most manufacturers (in their FDA-approved drug labeling) and many physicians will recommend that a nursing mother stop nursing if she takes a drug. The manufacturers most likely exclude pregnant and nursing women from their trials, so they don't generally have good information on breastfeeding compatibility when they seek approval for a new drug. Heck, it wasn't too many years ago that the companies often excluded women from clinical trials altogether because their menstrual cycles were "complicating factors"!

So, you'd be hard pressed to find medications of any sort, over-the-counter or prescription, that don't carry some sort of warning that pregnant and nursing women should consult their doctor before using the product. That's where the AAP list of drugs considered compatible with nursing can come in handy, even though it has no legal authority. And Dr. Hale's reference book has far more extensive information and is useful especially when a drug is not mentioned on the AAP list.

Finally, the others are right that lots of medications are prescribed for conditions or to populations that aren't included in the FDA approval. If you are being prescribed a drug for off-label use, it certainly makes sense to ask your doctor what studies he or she is using to base the decision.

ETA a new link I found:

http://www.aafp.org/afp/20020115/letters.html

This is a letter written by officials on the U.S. Food and Drug Administration Center for Drug Evaluation and Research Pregnancy Labeling Team. The letter mentions several obstacles to getting good information about the compatibility of breastfeeding and medications but notes that the FDA considers the subject an important area of research. Here's an excerpt:

"After a drug is marketed in the United States, new data can be incorporated into the label only if the pharmaceutical company that owns that drug submits the data along with the labeling supplement for FDA review and approval.5 Most published data regarding drugs and lactation are not proposed by companies to be included in drug labels, and there is no requirement that they do so. The FDA, through several scientific and regulatory initiatives, is working to change this and facilitate rational prescribing for pregnant and lactating women."

HTH.
Elizabeth, Mom to James, 9-20-02

[sntm]

everyone explained it really well.

off-label uses for drugs are very very very common. the guidelines for getting approval by the FDA for a specific use require a lot of time and money on the part of the manufacturer, who, once a drug is approved for enough reasons that the drug company is making the $$, doesn't really care. often, academic doctors will study drugs in their off-label use and get them subsequently approved but that takes funding from someone. finding that funding can be hard, especially if there is enough conventional wisdom that something works. i use off-label drugs frequently.
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shannon
not-even-pregnant-yet-overachiever
trying-to-conceive :)
PREGNANT! EDD 6/9/03
mama to Jack 6/6/03

[DebbieJ]

I am "breastmilk challenged" due to a reduction surgery seven years ago. I take Domperidone ordered via the internet from NZ--in fact many BFAR (breasfeeding after reduction) moms get it this way. Most times it ends up cheaper than getting it at a compounding pharmacy.

I had an LC tell me about it and she gave me ways to get it (Mexico, pharmacy) but based on the experience of the BFAR women I met online, I was comfortable with the NZ route.

~ deb
mommy to brendan 12/7/03