Advocacy Group Wants Oral Ketoconazole off U.S. Market

March 3, 2015

Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks.

In a petition, the group says the drug’s risks of fatal liver failure and adrenal insufficiency, as well a number of drug interactions, outweigh its limited benefits.

The petition, if successful, would affect just three manufacturers of the drug — Mylan, Taro and Teva. Johnson & Johnson’s Janssen subsidiary recently withdrew its branded version, Nozoral, from the market.

In 2013, the FDA issued a safety communication removing several approved indications for the drug, including its most common use, nonsystemic fungal infections. Nonetheless, sales of the tablet form declined by only 24 percent, from about 600,000 prescriptions dispensed in 2012, to 460,000 in 2014, the petition says.

This drug is not likely a blockbuster for any of the three companies, and loss of sales from the product won’t cause lasting harm, says David Rosen, an attorney at Foley & Lardner.

The FDA can take a year or longer to respond to citizen petitions, so any immediate impact is unlikely; however, they can be effective. From 1971 to 2012, Public Citizen filed 38 petitions to ban dangerous drugs. Twenty-five are now banned and eight are in very limited use, Sammy Almashat, a research with the organization’s Health Research Group, said.

The FDA doesn’t comment on the status of pending petitions. Mylan, Taro and Teva did not respond to requests for comment by press time.

Read the petition at www.fdanews.com/02-15-PetitionKetoconazole.pdf. — Jonathon Shacat