The international academy of compounding pharmacists posted a statement on
the use of domperidone when this FDA thing first started several years ago.
The statement is no longer on their website, but they were kind enough to
send me a copy of it. Basically, it says that the decision to use this
medication is up to the prescribing physician and the patient, and the FDA
does not have the authority to regulate compounded medications in the first
place. We have been getting it compounded with no problems at all by a local
pharmacist. I have a pdf of this statement that I am happy to share out -
text is pasted below:
Domperidone Update - June 2005
On May 18, FDA published a webpage entitled, "How to Obtain Domperidone." It
appears that FDA has recognized a medical need for domperidone indicated for
treatment of gastrointestinal disorders. However, FDA encourages that
domperidone prescribed for these purposes be obtained via an Investigational
New Drug application (IND). FDA continues to express concerns with
domperidone associated with lactation. To view FDA's announcement, go to
http://www.fda.gov/cder/news/domperidone.htm.
June 2004
Background
On June 7, 2004, the Food and Drug Administration (FDA) published an FDA
Talk Paper entitled, "FDA Warns Against Women Using Unapproved Drug,
Domperidone, to Increase Milk Production." The FDA states the paper was
written in response to reports that women may be using domperidone to
increase milk production and is warning women not to use this product due to
safety concerns.
The paper goes on to state that the FDA has issued six warning letters to
pharmacies that compound domperidone and is also issuing an Import Alert
which "alerts FDA field personnel to be on the lookout for attempts to
import the drug so it can be detained and refused admission into the US."
FDA states that they are concerned with potential health risks associated
with the drug and states that several published reports and case studies
have shown cardiac arrhythmias, cardiac arrest, and sudden death in patient
receiving intravenous form of domperidone. FDA is thus recommending that
breastfeeding women not use domperidone to increase milk production.
FDA lists no such health risks with the oral dosage form of the medication
when used for its approved indications.
On June 8th, Reuters picked up this story and to date has been published on
health related internet sites. The Wall Street Journal has also published an
article on the FDA action.
To access the FDA Talk Paper, visit www.fda.gov and click on "Women Warned
Not to Use Domperidone to Increase Breast Milk."
Discussion
As with all compounded medications, pharmacist and physician must work
closely with the patient evaluating applicable risks and benefits of
therapy. There is considerable literature on the use of domperidone and FDA
lists no health risks with the oral dosage form of the medication when used
at the appropriate dose for its approved gastric related indications by
other developed countries. When IACP asked FDA for more information on the
safety concerns, we were told no further information was being made
available at this time. Regarding lactation, some strongly support the use
of domperidone in spite of the limited studies. Thomas Hale, R.Ph., Ph.D.
Professor of Pediatrics, Texas Tech University School of Medicine, in a
letter to colleagues strongly disagrees with FDA's paper and he states that
domperidone is the safest product that can be used for stimulating milk
production in some women.
IACP disagrees with FDA statements in the warning letters that compounded
medications are new drugs subject to the provisions of the Food Drug
Cosmetic Act-specifically sections 502(f)(1) and sections 505. The
legislative history of the FDCA is clear that medications compounded in a
pharmacy pursuant to a prescription were not intended to be subject to the
provisions of the FDCA. Congress clarified in 1997 (503A) that compounded
medications are exempt from the new drug approval process and from good
manufacturing practices. Traditionally, FDA regulates the manufacturing of
drugs and State Boards of Pharmacy regulate the practice of pharmacy
compounding. Compounding differs from manufacturing in that a compounded
medication is prepared and dispensed pursuant to a valid prescription order
from a physician for a specific patient. Manufactured drugs are mass
marketed and distributed through wholesalers and eventually dispensed
through pharmacies to patients unknown to the manufacturer.
When adding 503A to the FDCA in 1997, Congress listed 3 criteria for using
pharmaceutical ingredients in compounding:
1.. 1) the pharmaceutical ingredient is a component of an FDA approved
product
2.. 2) The pharmaceutical ingredient has a USP/NF monograph
3.. 3) The pharmaceutical ingredient is published on a list of ingredients
approved for use in compounding. When considering pharmaceutical ingredients
FDA would consult with USP and the FDA advisory committee and use the
following criteria:
1.. a. the chemical characterization of the substance;
2.. b. the safety of the substance;
3.. c. the historical use of the substance in pharmacy compounding;
4.. d. the available evidence of the substance's effectiveness or lack
of effectiveness, if any such evidence exists.
Domperidone is not a component of an FDA-approved product nor does it have a
USP/NF monograph at this time. However, Domperidone would have been a likely
candidate for addition to the list of products allowed for use in
compounding based on the chemical characterization, safety, historical use,
and evidence of effectiveness as demonstrated in its broad approval by other
developed countries.
Domperidone is approved for use in Canada, UK, South Africa, New Zealand and
Australia. It is marketed by Janssen as MotiliumT in Canada and has the
following approved indications: "In the symptomatic management of upper
gastrointestinal motility disorders associated with chronic and sub acute
gastritis and diabetic gastro paresis. Domperidone may also be used to
prevent gastrointestinal symptoms associated with the use of dopamine
against antiparkinsonian agents."
Again, pharmacists and physicians must evaluate the risks (including
enforcement and liability) and benefits to the patient before dispensing or
preparing domperidone for a patient.
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