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a Publication of the Chief of Staff
Pharmacy Focus

FDA updates warnings for Intelence, orlistat, CellCept

Reports of Stevens-Johnson syndrome with Intelence

Revisions were made to the warnings and precautions section of the prescribing information for the HIV drug Intelence (etravirine), according to information from the Food and Drug administration and Tibotec Therapeutics. There have been reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. There also have been hypersensitivity reactions characterized by rash, constitutional findings and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.

FDA investigating liver-related events with orlistat

The FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat, which is marketed in the United States as the prescription product Xenical and as the over-the-counter product Alli.

Between 1999 and October 2008, 32 reports of serious liver injury, including six cases of liver failure, in patients using orlistat were submitted to the FDA's Adverse Event Reporting System. The most commonly reported adverse events described in the reports of serious liver injury were jaundice, weakness and abdominal pain. The FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat; analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. The FDA is not advising healthcare professionals to change their prescribing practices with orlistat.

Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

Cases of Pure Red Cell Aplasia reported with CellCept

The pharmaceutical company Roche has notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept, which lowers the immune response in transplant recipients. The FDA reports that the warnings and adverse reactions sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk, according to the FDA.