IA #60-03 - 11/21/97, IMPORT ALERT #60-03, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF BULK FENFLURAMINE AND BULK
DEXFENFLURAMINE NOT CONSIGNED TO AN APPROVED NDA HOLDER
OR IND HOLDER"
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert represents 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 does not operate to bind FDA or the public.)
PRODUCTS : Bulk Fenfluramine
Bulk Dexfenfluramine
PRODUCT
CODES : 60R[][]08 Fenfluramine
60R[][]99 Dexfenfluramine
PROBLEM : Misbranded - lacks adequate directions for use
(OASIS Charge Code - DIRECTIONS)
Misbranded - not listed (OASIS Charge Code - NOT LISTED)
PAF : REG
LBL
PAC FOR
COLLECTION: 52002
COUNTRY : ALL
MANUFACTURER/
SHIPPER: All foreign suppliers to consignees other than the approved manufacturer or
approved application holders, OR not consigned to the sponsor of an
investigational new drug in effect under 21 CFR 312.
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in
that the article appears to lack adequate directions for use [Misbranding,
502(f)(1)]."
OR
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that
it appears the drug or device is not included in a list required by Section 510(j), or a
notice or other information respecting it was not provided as required by Section
510(j) or 510(k), [Misbranding, 502(o)]."
RECOMMENDING
OFFICE : Center for Drug Evaluation and Research
(CDER)/Office of Compliance/Division of
Prescription Drug Compliance and Surveillance/
HFD-330.
REASON FOR
ALERT :FDA recently announced the withdrawal of the commercially manufactured
fenfluramine, A.H. Robins/Wyeth-Ayerst (manufacturer), (trade name Pondiminþ)
and dexfenfluramine, Interneuron (application holder), Wyeth-Ayerst (marketer) or
Boehringer Ingelheim (manufacturer), (trade name Reduxþ) products because the
use of these products has been associated with heart valvular abnormalities.
Acting on new evidence about these adverse effects, FDA requested the
manufacturers to voluntarily withdraw both treatments for obesity from the market.
The action was based on new findings from doctors who conducted ehocardiographic
evaluations of patients taking these two drugs either individually or in combination
with other drugs. Findings indicated that approximately 30 percent of patients
evaluated, though asymptomatic, had abnormal echocardiograms. This is a
higher-than-expected percentage of abnormal test results and presents an
unacceptable risk.
CDER's Office of Compliance has recently received information that, in response to
the manufacturers' withdrawal of fenfluramine and dexfenfluramine from the market,
a number of pharmacies in various parts of the country may be compounding these
products from bulk product received from unapproved sources. On October 1, 1997,
FDA issued an advisory to the State Boards of Pharmacy alerting them to this
information, and advising them that in light of the serious health risks, FDA has
significant concerns and expects pharmacies to refrain from distributing compounded
fenfluramine and dexfenfluramine products.
This advisory also requested that FDA be provided with any information regarding
the manufacturer and/or source of raw materials used in the compounding of these
products.
Known sources of fenfluramine and dexfenfluramine are:
FENFLURAMINE: Laboratori Mag SPA
Viale Gran Sasso 31
Milan, Italy 20131
NDC 12765-0134-4
FEI #1000315026
Laboratories Servier S.A.,
France
DEXFENFLURAMINE: Laboratori Mag SPA
Viale Gran Sasso 31
Milan, Italy 20131
NDC 12765-0136-6
FEI #1000315026
Labotatorios Servier S.A.
Toledo, Spain
FEI #3001134869
Oril S.A.
12 Rue August Desgenetaie
Bolbec, 76210 France
FEI #1000435915
GUIDANCE : Districts may detain without physical examination all bulk fenfluramine and
dexfenfluramine not consigned to the manufacturers or applicants of the approved
products, OR not consigned to the sponsor of an investigational new drug (IND)
in effect under 21 CFR 312.
Call the Division of Prescription Drug Compliance and Surveillance (DPDCS) at
(301) 594-0101 for information on IND sponsors to assure that supplies of these
products to IND holders are not detained.
Bulk drugs not consigned to the manufacturers or holders of the approved
applications should only be released after consultation with DPDCS. DPDCS
contact persons are Robert Tonelli or Kathleen Anderson (301) 594-0101.
For questions or issues concerning science, science policy, sample collection,
analysis, preparation, or analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.
PRIORITIZATION
GUIDANCE : N/A
FOI : Purging not required.
KEYWORDS : Fenfluramine, dexfenfluramine, Pondiminþ, Reduxþ, bulk drugs.
PREPARED BY : Alwin Collins, O & P SDWG, DIOP, (301) 443-6553.
DATE
LOADED INTO
FIARS : November 21, 1997
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