Import Alert 60-03

"Bulk Fenfluramine And Bulk Dexfenfluramine Not Consigned To An Approved
NDA Holder Or IND Holder"

FDA recently announced the withdrawal of the commercially manufactured fenfluramine, A.H. Robins/Wyeth Ayerst (manufacturer), (trade name - Pondimin) and dexfenfluramine, Interneuron (application holder), Wyeth Ayerst (marketer) or Boehringer Ingelheim (manufacturer), (trade name - Redux) 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 echocardiographic 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

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.

***Questions related to drug compliance issues may be directed to CDER/Office of Compliance (OC), Imports Exports Compliance Branch. The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***

Bulk drugs not consigned to the manufacturers or holders of the approved applications should only be released after consultation with ***the CDER/Office of Compliance (OC), Imports Exports Compliance Branch.***

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Fenfluramine, bulk Dexfenfluramine, bulk

"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)]."

OASIS Charge code - DIRECTIONS

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)]."

OASIS Charge code - NOT LISTED