(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:
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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.
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(c) This section does not apply to digoxin products for oral use, which shall be labeled according to the requirements of Sec. 310.500 of this chapter. [43 FR 22009, May 23, 1978]