DIGIFOLIN-CIBA NOT ADMITTED TO N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has authorized the publication of the following report, declaring Digifolin-Ciba inadmissible to New and Non­official Remedies.

W. A. Puckner, Secretary.

Digifolin-Ciba is a product of the Society of Chemical Industry of Basle, Switzerland. It is marketed in the United States by the Ciba Company, 91 Barclay Street, New York City. It is claimed that Digifolin-Ciba is “a preparation of digitalis leaves that has been freed from the useless and harmful principles such as Digitonin (saponin), coloring and inert matter, etc., but does contain all the really valuable, thera­peutically active constituents of the leaves, namely: digitoxin and digitalein in their natural proportions.” There is no evidence that digifolin contains all of the glucosides of digitalis as they exist in the leaf, and it is extremely improbable that this is the case because one cannot remove saponin without altering the other active principles of digitalis.

The Ciba Company sends out the following pamphlets relating to Digifolin:

“ ‘Concerning Digifolin-Ciba, A New Preparation of Digitalis,’ by C. Hartung, M.D., Ph.D. Extracts from the work ‘Ueber Digifolin, Ein Neues Digitalis-Praeparat’ in the Munich Medical Weekly, No. 36, page 1944, 1912.”

“ ‘Digitoxin Contents of Digifolin-Ciba,’ by C. Hartung, M.D., Ph.D., Basle, Switzerland. Reprints from the Pharmaceutical Post, 1913. No. 34, page 357. No. 40, page 431.”

“ ‘Pharmacological Tests of Digitalis,’ by M. J. Chevalier, Chef Des Travaux Pratiques de Pharmacologie et Matiere Medicale, Faculte De Medecine De Paris. Report Presented to the Societe de Therapeutique at Their Meeting, May 28, 1913.”

In the reprint “Concerning Digifolin, ‘Ciba.’ ” Hartung lays stress on the presence of harmful and inert substances present in the leaf and galenical preparations with the direct or implied statement that digifolin has an advantage in that these are absent from it. This is misleading. It is true that Boehm whom Hartung cites, found saponin to be irritating, but Boehm states that it required 100 mg. per kilogram of body weight to induce vomiting after its oral administration. Furthermore, saponin is present in traces only in infusion of digitalis, so that the therapeutic dose contains a wholly negligible amount of it.

The following occurs in “Pharmacological Tests of Digitalis,” by M. J. Chevalier:

“Hartung’s Digifolin merits our attention, especially because it seems to possess all the pharmacodynamic properties of galenic preparations of digitalis without showing any of their disadvantages.”

This claim scarcely needs comment, since it is well established that the chief “disadvantages” of digitalis are inherent in the principles which produce the desired effects of digitalis and may be avoided to a large extent by a carefully regulated dosage of any digitalis preparation. In short, the advertising for Digifolin asserts that this digitalis preparation has all the advantages of digitalis itself, but none of its disadvantages. This claim has been refuted so frequently that manufacturers must be aware that it is untenable. Further the claims now made for Digifolin are essentially those made nearly four years ago at which time the attention of the American agent was called to their unwarranted character.

The Council declared Digifolin-Ciba inadmissible to New and Non­official Remedies because the therapeutic claims advanced for it are misleading and unwarranted.—(From The Journal A. M. A., April 2, 1921.)