FDA warns about health dangers of Nizoral for fungal skin and nail infections

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by Jay Pate

The Food and Drug Administration has issued a warning about the dangers of prescribing the antifungal drug Nizoral to treat patients with fungal infections of the skin and nails, a treatment for which it has not been approved by the agency. The FDA warning states that because Nizoral has been linked to an increased risk of liver damage, adrenal problems, and serious drug interactions, the risks of using the antifungal drug to treat skin and nail infections outweigh the potential benefits.

Nizoral works by killing fungus or preventing it from growing. The drug is available in both pill form, taken orally, and a topical solution that is applied directly to fungal infections. About 217,000 prescriptions for the oral version of Nizoral were issued over the last 12 months for which records are available. Currently, Nizoral is only available as a generic prescription, known as ketoconazole.

The FDA originally warned in 2013 about the risk of using Nizoral to treat fungal infections of the skin and nails. Despite this warning, the agency found that doctors and other health care professionals continued to issue “off-label” Nizoral prescriptions to treat skin and nail fungal infections. In a 2015 FDA study, the agency found that skin and nail infections were the only diagnoses reported in cases when Nizoral was prescribed at a doctor’s office.

Since the FDA issued its warning about the risk of side effects for patients taking Nizoral, at least one patient has died from liver failure as a result of taking the drugs. The risks of liver damage, adrenal problems, or drug interactions associated with Nizoral have only been linked to the oral form of the drug; the topical version has not been linked to a risk of serious complications.

The new FDA warning about Nizoral advises doctors that the oral version of the drug should only be used to treat serious fungal infections in cases where no other alternatives are available. Because skin and nail fungal infections are not life threatening, the FDA advises that the risks of using Nizoral in these instances outweighs the potential treatment benefits.

The FDA is also advising patients that are taking Nizoral to seek medical attention if they experience potential symptoms of liver problems. These symptoms may include loss of appetite, nausea, vomiting, abdominal discomfort, jaundice, dark-colored urine, light-colored stool, or pain near the upper right abdomen.

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Despite the efforts of the FDA and other federal agencies, thousands of American patients are injured every year due to complications from prescription drugs and other medical products. In many cases, these injuries occur because the pharmaceutical industry puts profits ahead of patient safety, jeopardizing the health of consumers in favor of the “blockbuster” sales potential of drugs or medical devices.

If you or a loved one have been hurt after using prescription medications, medical devices, or other health products, you and your family may be entitled to file a lawsuit against the manufacturers, or the doctor or hospital who prescribed the medical product. The first step in taking legal action is to speak with attorney to learn more about your legal rights and find out if you may qualify to file a case.

The lawyers at Heygood, Orr & Pearson believe that when pharmaceutical companies and medical devices manufacturers put the health and safety of patients at risk through reckless or negligent conduct, they should be held accountable for their actions in a court of law. Heygood, Orr & Pearson has filed hundreds of lawsuits on behalf of patients who were injured by dangerous drugs. Our law firm has tried hundreds of cases to verdict, achieved settlements in hundreds more, and collected more than $200 million on behalf of our clients.

If you or a loved one has been hurt as a result of complications from prescription drugs or other medical products, contact the lawyers at Heygood, Orr & Pearson to learn more about your legal rights. For a free legal consultation and to find out more about whether you may qualify to file a lawsuit, please call us our firm toll-free at 1-877-446-9001. You can also contact us by following the link to our free case evaluation form and answering a few brief questions to get started.