The U.S. Food and Drug Administration (FDA) is warning the public that the oral form of the antifungal drug ketoconazole—sold under the brand name Nizoral—might cause severe side effects, including liver injury, adrenal insufficiency, and life-threatening side effects brought on by unpredicted drug interactions.
What Is Nizoral and What Is It Prescribed For?
Janssen Pharmaceuticals, now a member of Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, discovered ketoconazole in 1976. Scientists found that the chemical blocks the synthesis of ergosterol, a component of fungal cells’ membranes necessary for their survival. The FDA approved ketoconazole as Nizoral in 1981, and doctors can prescribe it to treat systemic fungal infections only if other effective antifungal therapies are not available or tolerated by patients. Nizoral comes in four forms: oral tablets; topical creams; topical shampoos; and oral suspensions. The FDA warning only applies to Nizoral’s oral tablet form.
Nizoral Might Cause Dangerous Side Effects
On July 26, 2013, the FDA issued a drug safety communication warning the public of dangers associated with Nizoral use: liver injury; adrenal insufficiency; and dangerous drug interactions. Because of the severity of these conditions, the FDA has ordered a change to the Nizoral drug label to include a “black box” warning for liver injury and dangerous drug interaction side effects.
Nizoral Liver Injury Side Effects
Medical science has found that Nizoral use can cause liver damage (hepatoxicity) that might result in a transplant or death. Damage can occur without warning after taking a high dose of Nizoral for a short period of time or a low dose of Nizoral over a long period of time. An FDA analysis showed that Nizoral was more likely to cause liver injury than similar antifungal drugs. A study conducted in the United Kingdom determined that one Nizoral user in 500 was at risk for a liver injury. Liver injuries in Nizoral users accounted for a disproportionate number of liver transplants compared to users of similar drugs.
Symptoms of Nizoral liver injuries include:
- Abdominal pain
Nizoral Adrenal Insufficiency Side Effects
The same characteristics that allow Nizoral to block ergosterol synthesis in fungal cells also inhibit the creation of adrenal steroids, particularly at high doses. The symptoms of adrenal insufficiency include:
- Gynecomastia in men (breast growth)
- Menstrual irregularities in women
Nizoral Drug Interaction Side Effects
The FDA is also concerned that when taken with other drugs, Nizoral can cause “QT interval” prolongation. The QT interval is a segment of the human heartbeat as defined in terms of electrical pulses. QT interval prolongation can indicate a type of irregular heartbeat called “Torsades de Pointes,” a potentially fatal condition. As a type of ventricular tachycardia (accelerated heartbeat), Torsades de Pointes’ symptoms include:
- Ventricular fibrillation (the uncoordinated contraction of the cardiac muscle of the heart’s ventricles)
- Cardiac arrest
- Sudden death
The drugs found to cause life-threatening interactions with Nizoral are:
- Tikosyn (dofetilide)
- Orap (Pimozide)
- Propulsid (Cisapride)
RLG’s Nizoral Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Nizoral lawsuit on your behalf if necessary. RLG will also keep you up to date on any Nizoral class action lawsuits, additional FDA Nizoral warnings, and Nizoral FDA recall announcements. If you have taken Nizoral and believe it harmed you, contact RLG today.