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`3/8/2016
`
`Public Citizen Press Room
`
`Feb. 24, 2015
`Antifungal Treatment Should Be Taken Off the Market, Public Citizen Tells
`FDA
`Ketoconazole Offe rs No Unique Benefits , Only Unique Risks Compared With Other, Safer
`Antifungals, According to FDA’s Own Experts
`
`Note: This release and the petition refer only to the oral form of ketoconazole and not to other
`formulations, such as creams.
`
`WASHINGTON, D.C. – The oral formulations of the antifungal medication ketoconazole should be
`removed from the market immediately because their questionable benefits are far outweighed by
`risks of severe liver injury and other side effects, Public Citizen said today in a petition to the U.S.
`Food and Drug Administration (FDA).
`
`Ketoconazole was approved in 1981 to treat fungal infections; however, over the past three
`decades, evidence has mounted about the risks of the medication. In 1983, a black box warning
`was added to the label about fatal liver damage. In July 2013, the FDA issued a safety
`communication restricting the approved uses of ketoconazole to rare, serious fungal infections and
`mandated that a medication guide be distributed with each prescription to inform patients of
`ketoconazole’s severe risks of liver injury, adrenal gland disorders and potentially dangerous
`medication interactions.
`
`The same day as the FDA’s announcement keeping ketoconazole on the U.S. market, a key
`committee of the European Medicines Agency (EMA, the European equivalent of the FDA)
`recommended that all forms of ketoconazole be removed from the European market because the
`agency had concluded that the risks outweighed its limited benefits for any fungal infection.
`
`In addition, Public Citizen learned – after obtaining an unreleased, internal agency memo – that six
`months before the FDA’s July 2013 announcement restricting ketoconazole, a team of FDA
`scientists at the Office of Surveillance and Epidemiology (OSE) reached the same conclusion as
`the EMA: that ketoconazole should be removed from the market.
`
`
`
`The OSE team was “unable to view the risk of serious potentially life-threatening [liver] injury as
`tolerable for the potential benefit of ketoconazole treatment” for any use. Importantly, the OSE
`scientists noted that, for all of ketoconazole’s remaining FDA-approved uses, multiple treatments
`exist that are safer and equally or more effective.
`
`In 2014, the year after the FDA rescinded ketoconazole’s most common uses ? for non-life
`threatening skin and nail infections ? 462,000 prescriptions were still dispensed for the medication,
`representing only a 24 percent decline from the 609,000 prescriptions dispensed in 2012.
`
`Using data relied on by the OSE scientists in their analyses, Public Citizen conservatively
`estimated that approximately 600 cases of liver injury requiring hospitalization or a referral to a
`liver specialist may have resulted from the 462,000 prescriptions for ketoconazole used in the
`United States in 2014.
`
`“The FDA’s own experts concluded that ketoconazole was too dangerous to remain on the market
`– for any of its approved uses – yet the agency continues to allow hundreds of thousands of
`prescriptions for the medication to be filled each year, likely resulting in hundreds of preventable
`cases of serious liver damage,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health
`Research Group. “The FDA needs to listen to its own scientists and follow the EMA’s example in
`banning ketoconazole as an antifungal treatment.”
`
`Read the petition and the OSE reviewers’ memo.
`
`###
`
`http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5423
`
`1/1
`
`JANSSEN EXHIBIT 2113
`Wockhardt v. Janssen IPR2016-01582
`
`