§ 201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

§ 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

Cross Reference

Link to an amendment published at 85 FR 72907, Nov. 16, 2020.

(a) Digitalis and related cardiotonic drugs for human use in oral dosage forms have been promoted for, and continue to be dispensed and prescribed for, use in the treatment of obesity, although their safety and effectiveness for that use have never been established.

(b) Digitalis and related cardiotonic drugs for human use in oral dosage forms are misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless their labeling bears the following boxed warning at the beginning of the “Warnings” section:

Digitalis alone or with other drugs has been used in the treatment of obesity. This use of digoxin or other digitalis glycosides is unwarranted. Moreover, since they may cause potentially fatal arrhythmias or other adverse effects, the use of these drugs in the treatment of obesity is dangerous.

(c) This section does not apply to digoxin products for oral use, which shall be labeled according to the requirements of § 310. 500 of this chapter.

[43 FR 22009, May 23, 1978, as amended at 85 FR 72907, Nov. 16, 2020]