The Food and Drug Administration (FDA) has raised serious warnings in conjunction with the use of Johnson & Johnson’s anti-fungal tablet, Nizoral, the use of which the FDA has suggested could raise the risk of fatal liver injuries. Warnings for the anti-fungal tablet advise using it in very limited amounts, particularly when taking Nizoral with other drugs and medications, which could result in harmful drug interactions. The tablet’s side effects are believed to be so serious, in fact, that regulators in both the United States and the European Union have issued advisory statements against the product.
In a statement released on Friday, July 26th, the FDA officially changed the information listed on the warning label of the anti-fungal tablet. Effective immediately, the warning label on all Nizoral drugs will advise that the anti-fungal tablet not be the first method of treatment for any type of fungal infection, no matter the nature or degree of the infection. In Europe, official actions against use of the drug have been taken even further, as the European Medicines Agency has recommended suspension of marketing for all oral treatments such as Nizora that have been found to contain ketoconazole.
The EU Agency feels strongly that the use of Nizoral poses far more risks than benefits among users; risks that include liver damage, adrenal-gland problems, and hepatitis. The FDA has also suggested that the liver injuries caused by use of the anti-fungal treatment could require a transplant or even result in death. Clearly, the seriousness of the issue is not to be taken lightly, as both the FDA and the EU Agency have taken actions to prove as much.
An important distinction that must be made in this report is that of the results that are produced by the Nizoral tablet versus results from other forms of the medication, which include gels, creams, foams, and shampoos that can be applied to the skin. None of the other forms of Nizoral have been connected to the same set of serious side effects that have arisen from use of the tablet. To date, no occurrences of liver damage, adrenal problems, or adverse drug interactions have been reported. The problem seems to be centralized solely in the use of the Nizoral tablet.
The severity of the health implications that can come from taking the Nizoral tablet is one that has caught not only the attention of the FDA, but also the attention of our California defective drug lawyers. At the Senators Firm, we feel strongly that incidents of this nature must be addressed in the legal system if they are to be prevented against in the future. In fact, it is for this very reason that we have dedicated so much of our personal injury practice specifically to cases involving defective products. We are here to help bring justice to the matter, as well as help you seek the compensation that you both need and deserve after suffering from the harmful effects of the Nizoral tablet.
If you need an attorney for a defective drug claim in California, don’t hesitate to contact The Senators Firm today.