[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.310]

[Page 64]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
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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