Serious skin reactions medically known as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment warns the Food and Drug Administration. According to the FDA, 6 cases have been identified in the US and 14 out of the US. Out of the 6 cases identified in the US 5 were children. All the cases resulted in hospitalization with one case of blindness and two deaths.
Read the FDA Safety Alert