HELMITOL OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

Helmitol is hexa­methylen­amin methylencitrate. It was introduced with the claim that it was superior to hexa­methylen­amin—which acts in acid fluids only—in that it is equally efficient whether the urine is alkaline or acid.

In 1918 The Bayer Company, which then marketed the product in the United States, was notified that the Council questioned the claims made for Helmitol and desired evidence to substantiate them. In 1919 the same notification was sent the Winthrop Chemical Company, which in the meantime had secured control of the product. Pending the submission of the evidence, the Council continued the acceptance of Helmitol for New and Non­official Remedies with the statement that the actions and uses of hexa­methylen­amin anhydro­methylen­citrate were those of hexa­methylen­amin.

W. A. Puckner, Secretary.

The following report on Helmitol was made by the referee in charge of hexa­methylen­amin compounds and preparations, adopted by the Council and sent the Winthrop Chemical Company:

“Helmitol is a compound of anhydro­methylen­citric acid and hexa­methylen­amin. It was introduced with the claim that it would be antiseptic even in alkaline urine. The Council did not entirely trust the evidence, but continued to list Helmitol in N. N. R., merely as a salt of hexa­methylen­amin, until satisfactory data should become available. These have now been furnished by Hanzlik (Journal of Urology 4:145) who has shown that:

“1. The alkalinity required to split off formaldehyd from anhydro­methylen­citric acid is greater than exists in the urine, even in advanced ammoniacal fermentation.

“2. Even if any formaldehyd were liberated in ammoniacal fermentation, it would at once become inactive by combining with ammonia.

“3. Urine after the administration of anhydro­methylen­citric acid actually putrefies readily.

“4. Less than 5 per cent. of the anhydro­methylen­citric radical reaches the urine, the remainder being destroyed in the body.

“The only reason for the existence of Helmitol was this claim of antiseptic action in alkaline and putrefying urines. Since this has been disproved, there remains no reason for retaining Helmitol in N. N. R.; on the contrary, its retention would only tend to continue the fallacy on which it is based.

“It is, therefore, recommended that Helmitol be no longer listed with New and Non­official Remedies, and that this report be published, after the usual submission to the manufacturers.”

In accordance with the recommendation of the report, the Council has directed the omission of Helmitol from New and Non­official Remedies and has authorized the publication of this report.—(From The Journal A. M. A., Jan. 22, 1921.)