The Food and Drug Administration said it would limit the use of Johnson & Johnson's antifungal medicine, Nizoral tablets, warning that it may cause severe liver injuries and adrenal gland problems, and lead to harmful drug interactions.
The agency said it approved changes to the drug's label to address the new safety issues. As a result, Nizoral oral tablets should not be the initial treatment for any fungal infection.
Topical formulations of Nizoral, including creams, shampoos, foams and gels, have not been associated with liver damage, adrenal problems or interactions with other drugs.
(Reporting by Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal)