Safety Alerts & Recalls

What does this mean?

After a complete review of the safety and efficacy of ketoconazole (Nizoral) oral tablets, the FDA has decided to limit the use of this medicine to the treatment of certain life-threatening fungal infections, known as mycoses, when the potential benefits outweigh the risks and other treatment options are not available or tolerated.

If you take oral ketoconazole or Nizoral tablets, please continue to take your medicine as directed by your healthcare provider. That said, you should contact your healthcare provider if you are taking ketoconazole (Nizoral) tablets for any non-life-threatening infection or if you are unsure of the seriousness of your infection, or if you have liver or adrenal problems. Your doctor can review this safety alert with you and make adjustments to your treatment if needed.

The FDA provides the following information for patients who take ketoconazole or Nizoral tablets:

1) Ketoconazole tablets may cause liver problems, including life-threatening liver failure or death.

2) Ketoconazole tablets can cause problems with the usual production of corticosteroid hormones.

3) Ketoconazole may interact negatively with other medications. If you take other medications besides ketoconazole tablets, it is important to discuss these medications with your healthcare provider, including the prescriber and your pharmacist.

4) Contact your healthcare provider right away if you take ketoconazole tablets and experience any of these signs and symptoms of liver problems:

- Loss of appetite, nausea, vomiting, or abdominal discomfort

- Fever, feeling unwell, or unusual tiredne

- Yellowing of the skin or the whites of the eyes (jaundice)

- Unusual darkening of the urine or lightening of the stool

- Pain or discomfort in the right upper abdomen, where the liver is located

5) Your healthcare provider may order laboratory tests to monitor how your liver is working while you are taking ketoconazole tablets and if you develop signs and symptoms of liver problems.

6) While taking ketoconazole tablets, do not drink alcohol or use drugs or medications (such as acetaminophen) that can cause liver problems.

7) Please read the patient Medication Guide that comes with your ketoconazole prescription.

Please discuss any questions or concerns about ketoconazole tablets with your healthcare provider.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use

The Food and Drug Administration (FDA) recently announced that it is taking several actions related to ketoconazole (Nizoral) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. The FDA has approved changes to the prescribing information and has added a new Medication Guide to address these safety issues.

In light of these warnings and limits to use, the FDA recommends ketoconazole oral tablets should not be the first treatment you receive for any fungal infection. Ketoconazole should only be used for the treatment of certain fungal infections, known as endemic mycoses, and even then, only when other antifungal treatments are not available or if they cause too many side effects.

The topical forms of ketoconazole (Extina, Xolegel, Nizoral) have not been associated with liver damage, adrenal problems, or drug interactions. These forms include creams, shampoos, foams, and gels applied to the skin, unlike the ketoconazole tablets, which are taken by mouth. There are no changes to the prescribing information for the topical formulations of ketoconazole.

For more information, please visit: more information here

Source: FDA
Publication Date: 2013-07-29
Last Updated: 2013-07-29

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