IA #61-07, 6/7/04, IMPORT ALERT # 61-07 , "DETENTION WITHOUT PHYSICAL EXAMINATION
OF DOMPERIDONE"
TYPE
OF ALERT: Detention without Physical Examination (DWPE)
NOTE: This import alert contains the Agency's current guidance
to FDA field personnel regarding the manufacturer(s)
and/or product(s) at issue. It does not create or
confer any rights for or on any person, and it does not
operate to bind FDA or the public.
PRODUCT: Domperidone, a/k/a: MOTILIUM, EUCITON, CILROTON, PRAXIS,
SERONEX, EMIKEN
PRODUCT CODE: 61 T - - --
PROBLEM: Unapproved drugs; Misbranded drugs
PAC: 56008H
PAF: LBL, AAP
COUNTRIES: All
MANUFACTURER/
SHIPPER: All
CHARGES: For finished products that appear to be intended for use as
drugs:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be a new drug under
the meaning of section 201(p) without an effective new drug
application, as required by section 505. [Unapproved new
drug, section 505(a)]"
For active pharmaceutical ingredients, including active
pharmaceutical ingredients that appear to be intended for use
in pharmaceutical compounding:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) because it appears to be a drug that is
misbranded in that it lacks adequate directions for its
intended use and it is not exempt from this requirement.
[Misbranding, section 502(f)(1)]"
OASIS CHARGE
CODE: UNAPPROVED; DIRECTIONS
RECOMMENDING
OFFICE: CDER, OC, Division of New Drug and Labeling Compliance (HFD-
310)
REASON FOR
ALERT: The agency has learned that domperidone (also known by the
above listed product names and the names contained in the
attachment to this alert), is being imported as a bulk API for
pharmacy compounding and as a finished dosage form. The
importation of this drug presents a public health risk and
violates the Federal Food, Drug, and Cosmetic Act (the Act).
BACKGROUND: The agency is concerned about the public health risks
associated with domperidone which is not approved for any use
in the U.S. There have been several published reports and
case studies of cardiac arrhythmias, cardiac arrest and sudden
death in patients receiving an intravenous form of domperidone
that has been withdrawn from marketing in several countries.
Among other uses, FDA has become aware of the use of
domperidone by lactating women to increase breast milk
production because of the drug's effect on prolactin levels.
While domperidone is approved in several other countries for
the treatment of gastric stasis and gastroparesis, domperidone
is not approved in any country for enhancing breast milk
production in lactating women. In several countries where the
oral form of domperidone continues to be marketed, labels for
the product note that domperidone is excreted in the breast
milk of lactating women and recommend that women taking
domperidone avoid breast-feeding. Because of this, FDA
recommends that breastfeeding women not use domperidone to
increase milk production.
The agency believes that these products may present serious
health hazards. Additionally, discretionary release of these
products under the Personal Importation guidance of Chapter 9
of the Regulatory Procedures Manual (RPM) may not be
appropriate.
GUIDANCE: Districts may detain without physical examination all
shipments of any finished drug products and all shipments of
bulk drug substances identified as containing domperidone.
Exceptions include situations where: (1) the bulk drug
substance is intended solely for tests in vitro or in animals
used only for laboratory research, under conditions set forth
in 21 CFR 312.160(a)(1)(i); or (2) the bulk drug substance
is to be used for non-clinical research and development and
product development, under the conditions set forth in 21 CFR
201.125.
Importers of bulk domperidone may obtain release of the
detained substance by providing documentation establishing
that the substance meets the conditions set forth in 21 CFR
312.160 or 201.125.
FOI: Purging is not required
CONTACT: Ada Irizarry, CDER/OC/DNLC 301-827-8967
KEYWORDS: Domperidone; Motilium; Euciton; Cilroton; Praxis; Seronex;
Emiken
PREPARED
BY: Margaret M. O'Rourke/CDER/OC/DNLC 301-827-8970
Dave Krawetz, DIOP, 301-594-3872
DATE LOADED
INTO FIARS: June 7, 2004
Attachment - names of foreign versions of Domperidone
Alplax Net (Gador, Arg.), Bigetric (Casasco, Arg.),
Bilagol (Lazar, Arg.) Biolix (Bioresearch, Mex.),
Cilroton (Janssen-Cilag, Gr.), Cinet (Medinfar, Port.)
Costi (Medochemie, Hong Kong), Costi (Medochemie, Thai.),
Dany (The Forty-Two, Thai.) Digestivo Giuliani (Giuliani, Ital.)
Dolium (Utopian, Thai.), Domerdon (Asian Pharm, Thai.)
Domidone (Milano, Thai.), Domilium (LSP, Thai.),
Dompel (Samnam, Singapore) Dompenyl (Korea United, Singapore)
Dompeon (Merck, Hong Kong), Domper (YSP, Malaysia)
Domper (Yung Shin, Singapore), Domperamol (Servier, UK),
Domperdone (Polipharm, Thai.) Domperidone Tablets BP 2003,
Domper-M (Bangkok Lab & Cosmetic, Thai.), Domperol (Farmion, Braz.)
Dom-Polienzim (Sanitas, Arg.), Domstal (Torrent, India),
Donum (M & H, Thai.) Doridone (DHA, Singapore),
Ecuamon (Lazar, Arg.), Emiken (Kener, Mex.)
Euciton (Roux-Ocefa, Arg.), Euciton Complex (Roux-Ocefa, Arg.)
Evoxin (Sterling Research, UK) Faradil Novo (Sidus, Arg.)
Fobidon (IBN, Ital.), Gastrocure (Taxandria, Neth.)
Gastronorm (Janssen-Cilag, Ital.), Megalex (Phoenix, Arg.),
Mirax (Berlin Pharm, Singapore) Mirax (Berlin Pharm, Thai.)
Mocydone (Pharmasant, Thai.), Mod (IRBI, Ital.)
Modomed (Medifive, Thai.), Mogasinte (CPH, Port.),
Molax (Siam Bheasach, Thai.) Moperidona (Sidus, Arg.)
Moperidona AF (Sidus, Arg.), Moperidona Enzimatica (Sidus, Arg.)
Moticon (Condrugs, Thai.), Motidom (TO-Chemicals, Thai.)
Motilidone (Technilab, Canad.) Motilium (Byk Gulden, Ger.)
Motilium (Esteve, Spain), Motilium (Janssen, Hong Kong)
Motilium (Janssen, Mex.), Motilium (Janssen, Thai.),
Motilium (Janssen-Cilag, Arg.) Motilium (Janssen-Cilag, Austral.)
Motilium (Janssen-Cilag, Austria), Motilium (Janssen-Cilag, Belg.)
Motilium (Janssen-Cilag, Braz.), Motilium (Janssen-Cilag, Denm.)
Motilium (Janssen-Cilag, Fr.) Motilium (Janssen-Cilag, Irl.)
Motilium (Janssen-Cilag, Israel), Motilium (Janssen-Cilag, Ital.)
Motilium (Janssen-Cilag, Malaysia), Motilium (Janssen-Cilag, Neth.)
Motilium (Janssen-Cilag, NZ) Motilium (Janssen-Cilag, Port.)
Motilium (Janssen-Cilag, S.Afr.), Motilium (Janssen-Cilag, Singapore)
Motilium (Janssen-Cilag, Switz.), Motilium (Janssen-Ortho, Canad.)
Motilium (Sanofi Synthelabo, UK); Johnson & Johnson MSD Consumer, UK)
Motilyo (Janssen-Cilag, Fr.), Movelium (Progress, Thai.),
Nautigo (Bell, India) Nauzelin (Janssen-Cilag, Spain)
Ninlium (Chinta, Thai.), Nordonil (Medinfar, Port.)
Peptomet (Remedica, Thai.), Peridal (Medley, Braz.),
Peridon (Italchimici, Ital.) Peridys (Pierre Fabre, Fr.)
Pleiadon (Zambon, Braz.), Pondperdone (Pond's, Thai.)
Poselium (Pose, Thai.), Praxis (Armstrong, Arg.),
Rabugen (Unison, Hong Kong) Remotil (Azevedos, Port.)
Seronex (Medix, Mex.), Tetralgin Novo (Craveri, Arg.)
Touristil (Janssen-Cilag, Belg.), Vegestabil Digest (Labinca, Arg.)
Vivadone (Lexon, UK) Vomidon (Be-Tabs, S.Afr.),
Zilium (Wolfs, Belg.)