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`http://www.fda.gov/Drugs/DrugSafety/ucm371017.htm
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`35 captures
`18 Oct 2013 - 11 Jun 2019
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`Drug Safety and Availability > FDA advises against using oral ketoconazole in drug interaction studies due to serious potential side effects
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`2012 2013 2014
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`Home Drugs Drug Safety and Availability
`Drugs
`FDA advises against using oral ketoconazole in drug interaction studies due to serious potential
`side effects
`[10/16/2013] The U.S. Food and Drug Administration (FDA) recommends that drug companies and researchers
`avoid using oral ketoconazole in drug interaction studies. Serious potential liver injury and adrenal gland
`problems make using the drug risky, and other strong CYP3A inhibitors are available that can be used as
`alternatives in drug interaction studies.
`On July 25, 2013, FDA limited the use of Nizoral (ketoconazole) oral tablets to patients who do not have the
`option of taking alternative antifungals and who are undergoing treatment for certain fungal infections known as
`endemic mycoses (see Drug Safety Communication1). We took this action because oral ketoconazole can cause
`severe liver injuries and adrenal gland problems and may lead to harmful interactions with other drugs.
`Oral ketoconazole has sometimes been used as a strong CYP3A inhibitor in drug interaction studies designed to
`predict the effect of other CYP3A inhibitors on a drug that is being studied. The information gained from such
`studies helps determine whether a health care professional needs to take a specific safety-related action when
`prescribing a drug in conjunction with a CYP3A inhibitor.
`Most ketoconazole drug interaction studies are conducted in healthy subjects. In view of serious potential side
`effects associated with the drug, we recommend against the exposure of study subjects to ketoconazole. The
`dose of oral ketoconazole typically used in drug interaction studies (200-400 mg as a single dose or daily for as
`many as 5 days) is within the range of doses associated with liver injury. Instead of ketoconazole, FDA
`recommends that clarithromycin or itraconazole be used as the strong CYP3A inhibitor in drug interaction studies
`However, investigators can suggest other strong CYP3A inhibitors.
`
`Related Information
`FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially
`fatal liver injury and risk of drug interactions and adrenal gland problems2
`
`Page Last Updated: 10/16/2013
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`Links on this page:
`1. /web/20131018234822/http://www.fda.gov/Drugs/DrugSafety/ucm362415.htm
`https://web.archive.org/web/20131018234822/http://www.fda.gov/Drugs/DrugSafety/ucm371017.htm
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`1/2
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2063, Page 1
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`
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`2/11/2020
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`Drug Safety and Availability > FDA advises against using oral ketoconazole in drug interaction studies due to serious potential side effects
`👤 ⍰ ❎
`SEP OCT NOV
`http://www.fda.gov/Drugs/DrugSafety/ucm371017.htm
`Go
`2. /web/20131018234822/http://www.fda.gov/Drugs/DrugSafety/ucm362415.htm
`18
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`f 🐦
`35 captures
`2012 2013 2014
`▾ About this capture
`18 Oct 2013 - 11 Jun 2019
`
`https://web.archive.org/web/20131018234822/http://www.fda.gov/Drugs/DrugSafety/ucm371017.htm
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`2/2
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2063, Page 2
`
`
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