In a major disappointment for Johnson & Johnson (JNJ), the US Food and Drug Administration (FDA) has asked the company to strengthen the warning for its HIV drug Intelence regarding a deadly skin reaction. The warning has been updated after the death of a patient from the skin reaction known as toxic epidermal necrolysis was reported. Additionally, another case of liver failure was reported in a patient who subsequently recovered.
Since the launch of Intelence in January 2008, the product has included a warning about the risk of severe skin reactions, though the rate of serious allergic reactions was quite less in the clinical trials (less than 0.1%). The drug, used in combination therapy for HIV treatment, has marketing authorization in Canada and the European Union as well. J&J has asked the doctors to stop administering Intelence if any case of such allergic reaction is noticed.
As if the Intelence issue was not enough for J&J, the company received a violation letter from the US regulators regarding a misleading advertisement of Ertaczo, a cream used to treat the fungal infection that causes ringworm, athlete’s foot and jock itch. While the company claims the cream eradicates the infection completely, clinical trials have proven it to be modestly effective. Along with this, the agency noted the omission of safety features. Although the advertisement included some of the adverse events associated with the product, it failed to include any of the warning or precautionary measures related to it.
The FDA has set September 4 as the last date within which J&J has to respond detailing its course of action. Although the company was supposed to submit the advertisement to the agency before running it in any of the journals, the company failed to do so.
J&J is reviewing the letter and preparing a response within the due date. Although neither of the two products has any significant contribution to the company’s top-line, we hope the issues will be resolved quickly in the greater interest of all the patients concerned.
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