FDA Releases Safety Alert for Nizoral

Dangerous drug lawyers at Pintas & Mullins Law Firm announce that the FDA recently placed strict limits on the use of Nizoral (generic ketoconazole) for any type of fungal infection. The drug may cause liver toxicity, adrenal gland problems, and dangerous interactions with other drugs.

The agency approved changes to Nizoral’s labeling and added a completely new Medication Guide to address these issues. As a result of these newly discovered dangers, Nizoral should no longer be used as a first-line treatment for fungal infections (known as endemic mycoses), and should only be used with alternative therapies are inaccessible or intolerable.

The European Union’s Committee on Medicinal Products for Human Use (CHMP) took it one step further, recommending that EU counties pull the oral formulation of Nizoral completely. Both the CHMP and FDA cited several studies which concluded that Nizoral was associated with severe acute liver injury.

The FDA acknowledges that Nizoral is indeed among the most potent inhibitors of the CYP3A4 enzyme, which catalyzes the release of adrenal (kidney) steroid hormones and can thus lead to adrenal insufficiency. Unfortunately, numerous other drugs are metabolized by the CYP3A4 enzyme, which can lead to life-threatening interactions.

For this reason, Nizoral often causes clinically significant abnormalities in the secretion of hormones in the body, which was observed particularly in high doses. For men, effects included gynecomastia; for women, menstrual irregularities.

If it becomes necessary to administer Nizoral because of the severity of infection, physicians are urged to assess liver functioning before starting the drug. Patients should be informed not to drink alcohol or use any potentially hepatotoxic drugs while on Nizoral. Adrenal function should be monitored while the patient is on the drug.

The FDA recommends that physicians stop prescribing Nizoral immediately and begin reviewing alternatives in patients already on the medication. The agency revised the drugs’ Boxed Warning (the most serious type of warning about these types of issues), adding strong proposal against its use, particularly in those with any liver abnormalities. The new warning also advises patients to undergo routine liver monitoring for signs of toxicity. Nizoral is also available topically, as a cream, shampoo, foam or gel. Topical forms of the medication, the FDA asserts, are still okay to use as they have not been found to affect the liver in any way.

A Boxed Warning was also recently added for the antimalarial drug mefloquine hydrochloride. The drug’s label now includes the possibility of neurological and psychiatric side effects, which may persist or become permanent. Nerve side effects may include dizziness, ringing of the ears, and loss or balance. Psychiatric side effects may include feeling depressed, mistrustful, anxious, or having hallucinations.

The neurological side effects can appear at any point during drug use, and may last for months, years, and can even become permanent. Mefloquine hydrochloride was previously sold as Lariam, for treatment of mild to moderate acute malaria.

Dangerous drug lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those injured by defectively designed or manufactured drugs such as Nizoral and mefloquine. If you or a loved one was hospitalized or seriously injured by a dangerous drug, contact a skilled pharmaceutical attorney who can inform you of your legal rights at no cost to you.

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