If you are taking Nizoral (ketoconazole) there is an important FDA Drug Safety Communication that you should know about.
FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
This safety announcement is an update to the July 26, 2013 FDA Drug Safety Communication regarding Nizoral (ketoconazole) oral tablets. In the July 2013 communication, the FDA warned of the risk of adrenal gland problems and drug interactions and the potential for fatal liver injury from the use of Nizoral.
The FDA approved label changes for oral Nizoral to warn of the potential health risks associated with using the drug and removed the use of the drug to treat skin and nail infections. Since the labeling change in June 2013, one person has died due to liver failure associated with oral ketoconazole prescribed to treat nail fungal infection.
New FDA Warning Regarding Oral Nizoral
In its most recent drug safety communication regarding Nizoral, the FDA warns that Nizoral continues to be prescribed for the treatment of skin and nail infections despite the FDA’s 2013 warning. From a review of physician surveys during the 18 months prior to June 2015, the only diagnoses given for the use of oral Nizoral was skin and nail fungal infections.
Because it appears that physicians are continuing to prescribe oral Nizoral to treat nail and skin fungal infections, the FDA issued the new warning advising doctors to avoid prescribing oral ketoconazole to treat nail and skin fungal infections because the potential risks outweigh the benefits. The treatment of these conditions ae not approved uses of the drug. Ketoconazole in oral form is only indicated to treat serious fungi infections when other effective treatments are not available or tolerated. The topical forms of the drug have not been associated with the same dangers.
If your doctor prescribes ketoconazole tablets or oral Nizoral, you should discuss the potential danger and report any side effects to the FDA’s MedWatch program, then contact an injury lawyer who handles pharmaceutical litigation claims at The Olinde Firm to discuss your legal rights.
Have You Been Injured After Taking A Drug?
Unfortunately, defective drugs cause serious injuries and deaths each year in the United States. Manufacturers must be held accountable when the drugs they produce injury patients. In some cases, doctors can be held accountable if they prescribed the drug for uses that are not approved by the FDA. An experienced defective drug attorney can help you determine what causes of action you may have regarding a defective drug.
Contact the defective drug attorneys of The Olinde Firm at (504) 587-1440 or 1-800-587-1889 to schedule a free legal consultation. Our New Orleans product liability attorneys handle drug lawsuits from all over the United States. You may be entitled to receive compensation for your injuries including medical bills, lost wages, physical pain, and emotional suffering but your times to file a claim is limited. Contact us today!