[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.310]
[Page 82]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.310 Phenindione; labeling of drug preparations intended for use
by man.
(a) Reports in the medical literature and data accumulated by the
Food and Drug Administration indicate that phenindione, a synthetic
anticoagulant drug, has caused a number of cases of agranulocytosis
(with two fatalities). There are also reports implicating the drug in
cases of hepatitis and hypersensitivity reactions. In view of the
potentially serious effects found to be associated with preparations of
this drug intended for use by man, the Commissioner of Food and Drugs
will regard such preparations as misbranded within the meaning of
section 502(f) (1) and (2) of the Federal Food, Drug, and Cosmetic Act,
unless the label and labeling on or within the package from which the
drug is to be dispensed, and any other labeling furnishing or purporting
to furnish information for use of the drug, bear a conspicuous warning
statement to the following effect: ``Warning: Agranulocytosis and
hepatitis have been associated with the use of phenindione. Patients
should be instructed to report promptly prodromal symptoms such as
marked fatigue, chill, fever, and sore throat. Periodic blood studies
and liver function tests should be performed. Use of the drug should be
discontinued if leukopenia occurs or if evidence of hypersensitivity,
such as dermatitis or fever, appears.''
(b) Regulatory action may be initiated with respect to preparations
of phenindione intended for use by man found within the jurisdiction of
the act on or after November 25, 1961, unless such preparations are
labeled in accordance with paragraph (a) of this section.
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