A smear campaign against ketoconazole ?

[26 July 2013] European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole. www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/07/WC500146613.pdf
Reference: Garcia Rodriguez et al., A cohort study on the risk of acute liver injury among users of ketoconazole and other antifugal drugs, Br J Clin Pharmacol 1999; 48(6):847-852.
The study: 1052 patients used ketoconazole, 2 (two !, one man and one woman) developed acute liver injury. So this study is already 14 years old (and was sponsored by Novartis).

[7-26-2013] The U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) 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.
www.fda.gov/Drugs/DrugSafety/ucm362415.htm
Reference: The recommendation of the European Medicines Agency above.

N.B. Ketoconazole was discovered in 1976 and released in 1981. So after 32 years it now becomes dangerous to use. Or maybe it has to be replaced by a new drug, 10-50 times more expensive ? Of course I get it 'off label' for my mCRPC, since feb 2011, and the only SE I experienced was from the hydrocortisone(HC) that is given additionaly. If you use the low-dose keto-treatment dr. C. S. Myers thinks that you don't need HC at all.

A “smear” campaign?   Maybe “important warning” might be more appropriate.   You do realize, I assume, that the articles you posted (from the FDA and the European Union equivalent) both clearly say that this announcement is specific for, and limited to, the use of Ketoconazole for the first-line treatment of fungal infections. With several people dying , and several others requiring emergency liver transplants , the risk of the product for treating toe fungus does not outweigh the benefits , in the opinion of the EMA and FDA...which seems wise to me.   Other uses, and cases when an alternative antifungal therapy are not available or tolerated, are not barred.   When I saw my dermatologist last year for my annual check-up (recommended, starting age 50), he recommended a Ketoconazole product for a toe fungus I had…I recognized the name from my PC learnings.   It required two liver tests prior to starting the prescript ion…for a toe fungus!   I didn’t “need” to be treated for this, and the drug risks were fairly substantial, and on top of that I was instructed to stop all alcohol consumption—which didn’t mesh well with my daily red wine/resveratrol to fight PC, and more significantly heart disease.   After I read-up on the drug, I chose not to take the prescript ion… toe fungus treatment was clearly “elective.”   I ended up rubbing Ben-gay on it instead, which worked pretty well.  

Casey,

I don't often agree with you wholeheartedly, but this is an exception.
The side effects are not worth the benefits for toe fungal infections.

An