FDA issues strongest warning for drug prescription without a recall." /> Deadly Fungal Cure FDA issues strongest warning for drug prescription without a recall" />

Deadly Fungal Cure

Off-label oral Ketoconazole may cause death.

By Kevin RR Williams

HEALTH There could hardly be a more serious warning from the U.S. Food and Drug Administration (FDA). Ketoconazole tablets (Nizoral, Janssen Pharmaceuticals) has been prescribed to treat skin and nail fungal infections. The FDA now warns that serious liver damage and death outweigh benefits. Likely, you agree.

When this alert hit my inbox, it struck close to home. Before Nizoral shampoo was available over the counter, I had a prescription for it to treat flakey scalp. It was something I used for several years. Note that the FDA warning is for ingestion of the drug. Years later, I discovered a severe mold, mildew and fungus allergy. Some carpet had to be ripped up, pipes and water heater replaced. It was a mess. About that time, some rashes had developed along with flakey scalp. An appointment with a dermatologist was thwarted by a Physician’s Assistant (PA). Though PAs receive extensive medical training and may obtain an MS degree, they are not doctors. In some states, however, they are permitted to prescribe medicine. Guess what my PA prescribed. Yep, Ketoconazole tablets.

Spoiler alert: It didn’t kill me. But there were some adverse reactions, which may differ from other patients. On the positive side, my skin cleared up nicely. In fact, I was enjoying a fuller head of hair as a result of a healthier scalp. The bliss was not without side effects. I was in a state of delirium and fatigue. Since it seemed to be working, I endeavored to push through the dizziness figuring my system had to get used to the prescription.

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On the fifth day, I phoned the dermatologist (real doctor) and asked if the dosage could be reduced because of the side effects. He advised me to discontinue taking it immediately. I tried to soften the tone by sharing the benefits noticed. He reiterated, "Stop taking it.” This was years before the FDA warning. Likely it was due to my mold and mildew allergy that by extension includes penicillin — a Ketoconazole contraindication.

Curiously, when I went in to see the head of dermatology (same one that advised discontinuance of prescription), the PA no longer worked there. Putting my experience in context, the words "death” and "Ketoconazole" in one sentence caused a bit of alarm. Happily, my experience with the drug topically and orally occurred more than six years ago and my liver was preserved.

The take-away is that oral prescriptions of Ketoconazole for skin infections should be discontinued. Do not attempt to bypass the FDA warning by purchasing pills online or obtaining them from another patient. If you have been taking a prescription for more than a week or two, a liver function test is advised.

Tags: dangerous, dermatology, mortality, skin, warning