Warning over Janssen's Nizoral tablets

The US Food and Drug Administration is taking action over anti-fungal Nizoral (ketoconazole) oral tablets made by Janssen Pharmaceutical, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), warning that it can cause severe liver injuries.

The FDA is also warning that it can cause adrenal gland problems and advising that it can lead to harmful drug interactions with other medications.

The Wall Street Journal reported that Johnson & Johnson said the manufacture of the tablets for the US market had been suspended before the FDA announcement. The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) this month recommended against continued sale of ketoconazole-containing products in Europe ( The Pharma Letter July 26), but that the company continues to sell the tablets in some other countries, according to the WSJ.