Sign the Myodil
Action Group e-petition
Walton Van Winkle (FDA Acting Chief, Drug Division) expresses concerns
to Lafayette about quality control during
manufacturing of Pantopaque (Myodil), adverse reactions of animal tests
reports of the same in Humans. He was also unhappy about the
of testing for free Iodine in the product and other concerns.
These issues were never resolved.
Pharmacal Inc. Jan 21 1944
of Mr. W. S. Bucks
consideration has been given to your application under section 505 of
the Federal Food, Drug and Cosmetic Act for the preparation
“Pantopaque”. From the description of control
contained in this application, we are somewhat in doubt as to the
extent of the test to be made on each batch of the drug. In discussing
the preparation of the active ingredient, we note that certain physical
constants are mentioned and that the drug is assayed Mologically on
dogs. It also appears that a total iodine content determination is
made. We assume that these examinations are made either by the Eastman
Kodak Company or by the University if Rochester. It does not appear
that you exert any chemical control over the drug after you receive the
raw materials. In our opinion it will be highly desirable for some
further check to be made of the finished packaged product. We, of
course, are not in a position to state what sort of a test is most
desirable, but we feel that the manufacturer should assure himself that
the product, before distribution in the channels of commerce, meets the
criteria for quality and purity as specified in this application. It is
also suggested that in addition to the tests proposed in the
application, a test for free iodine be included. This is particularly
desirable in that no information has been furnished concerning the
stability of this product, other than the fact that the colour changes
on exposure to light.
clinical reports which have been submitted leave one with the
impression that a rather large number of reactions of varying degree of
severity have been observed with the use of this material. We are aware
that some of these reactions may be accounted for by the fact that the
investigators failed to remove the material following examination of
the patient. However, on the basis of the reports contained in the
application and without additional data, we hesitate to permit this
application to becomes effective on the basis of its safety for use. It
is suggested that additional reports be obtained from some of the
investigators mentioned in the application to whom material has been
sent but who have not submitted reports. We would be particularly
interested in having them state their opinion of the safety of this
preparation as compared to lipidol and to discuss the nature and
severity of the reactions observed by them as compared to those
observed when lipidol is used.
our opinion, the proposed circular setting forth the indications and
method of administration of this product is not wholly satisfactory.
Because of the severity of reactions observed in patients in whom the
product is not removed after injection, we feel that considerable
stress should be laid upon the necessity for removing this material on
completion of the radiologists examination. It might be well for the
label to bear a caution calling this fact to the physicians attention.
The entire circular created the impression that reactions are
infrequent and are of a minor character. The reports which have been
submitted do not confirm this impression. We suggest, therefore, that a
more thorough discussion of the side reactions and potential toxicity
be given in the circular and that it be stressed that these reactions
appear almost uniformly if the product is not removed following
examination of the patient. It is also suggested that the circular
state that the product is not intended for use in the bronchi or in the
the time you submit the additional data regarding controls and
toxicity, you should also submit a draft of a proposed revised circular
Van Winkle M.D.
Chief, Drug Division.