Public Citizen Petitions FDA to Recall Fungal Drug Ketoconazole

Public Citizen Petitions FDA to Recall Fungal Drug Ketoconazole

Posted By Golomb & Honik, P.C. || 14-Mar-2015

The consumer advocacy group Public Citizen has recently petitioned the FDA to recall the fungal medication ketoconazole due to concerns over an increased risk of liver damage. In their statement to the FDA, Public Citizen made the following claims:

  • The risk of liver damage far outweighs the "questionable" benefits of this drug
  • The FDA sent an internal memo in 2013 that classified the risks associated with ketoconazole as intolerable
  • Back in 1983, the FDA had issued a black box warning, the highest safety concern they have, due to the potential for fatal liver damage

As recently as 2013, the FDA had issued a safety notice that limited the number of approved uses of ketoconazole on the product's labeling due to the risk of liver damage, adrenal gland dysfunction, and a high risk of dangerous interactions with other drugs. Even with regards to the remaining approved uses of the drug - treatment of five different fungal infections - the FDA urged that ketoconazole only be used as a last resort. Ketoconazole has already been taken off the market in Europe due to these safety concerns.

The FDA is currently reviewing the Public Citizen petition and will hopefully make a decision shortly.

If you've suffered serious liver damage due to taking one of the generic forms of ketoconazole, you may be entitled to recover compensation for your damages. Our pharmaceutical injury lawyers at Golomb & Honik, P.C. have decades of experience handling these complex cases. We have the vast resources to take on the high powered legal teams employed by pharmaceutical companies, and we've earned lucrative verdicts and settlements on behalf of many drug injury victims. Call us today at (215) 278-4449 for dedicated legal services.

Categories: Dangerous Drugs
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