DIGALEN OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
Digalen is a proprietary said to contain a soluble form (digitoxinum solubile Cloetta) of digitoxin, the chief active principle of digitalis. This preparation was accepted[25] by the Council in 1909 for inclusion in New and Nonofficial Remedies. The Council had not at that time determined whether Digalen contained “soluble amorphous digitoxin,” as claimed, or not. The product was accepted merely as a standardized soluble and fairly stable digitalis preparation.
After the acceptance of Digalen, the therapeutic claims made for it by the manufacturers increased in extravagance. Meanwhile, evidence was brought forward by various independent investigators which tended not only to show that these therapeutic claims were unfounded, but also to discredit the claim that Digalen contained a principle chemically identical with digitoxin. In view of the obscurity of the whole subject of the chemistry of the digitalis principles, the latter claim (that Digalen was a solution of “amorphous digitoxin”) had been an academic issue at the time of the acceptance of the product. When, however, the manufacturers of Digalen sought to mislead physicians by increased and unwarranted therapeutic claims, the Council felt that investigation of the whole matter was imperatively demanded to decide whether or not Digalen should be retained in N. N. R.
The questions at issue were: (1) the presence in Digalen of “amorphous digitoxin”; (2) the constancy of composition and reliability of action of Digalen, and (3) the claim that it causes less gastric disturbance than digitoxin. No satisfactory proof has yet been offered that Digalen contains “amorphous digitoxin.” The mass of evidence tends to show that Digalen is not constant in composition or reliable in action, and that, when given in doses corresponding in therapeutic activity, Digalen causes quite as much gastric disturbance as the official galenical preparations of digitalis.
The outcome of protracted negotiations between the Council and the Hoffmann-La Roche Chemical Works may be summed up as follows: 1. The manufacturers promise to hold in abeyance the claim regarding the presence of “amorphous digitoxin.” 2. They refuse to concede the variable composition of Digalen. 3. They reassert the claim that Digalen is superior to other digitalis products with respect to liability to cause gastric irritation and consequent vomiting.
In view of the unsatisfactory character of the reply on the second and third points, the Council voted that Digalen be omitted from N. N. R. and that publication of the report on Digalen which appears below be authorized, as well as of the two reports[26] (A and B) referred to therein.
W. A. Puckner, Secretary.