PMDA updates labels of two anticancer agents following deaths
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PMDA updates labels of two anticancer agents following deaths The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has announced updates to the labelling of temozolomide and mogamulizumab, as a result of severe adverse events, including fatal events, occurring in patients treated with these anticancer agents.* The temozolomide [Temodal] label now warns of the risk of reactivation of hepatitis B virus among hepatitis B virus carriers and HBs antigen-negative patients.1 The PMDA says that, since April 2009, it has received four case reports involving reactivation of hepatitis B virus, including the one fatal case. In 2011 alone, approximately 3500 patients received the drug. The mogamulizumab [Poteligeo] label is being updated to warn that severe skin disorders associated with general symptoms such as toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome have been reported.2 The label advises that treatment should be provided in collaboration with a dermatologist, and patients should be carefully monitored for several weeks after administration. Since initial marketing of this drug in May 2012 through to October 2012, the PMDA had received four reports of TEN, including one fatal case. It is estimated that 380 patients had received the drug over this time period. * See this issue p32; 803084100 and p24; 803084101, respectively. 1. Pharmaceutical and Food Safety Bureau. Important Safety Information Temozolomide. Pharmaceuticals and Medical Devices Safety Information 298: 11-13, Jan 2013. Available from: URL: http://www.pmda.go.jp. 2. Pharmaceutical and Food Safety Bureau. Important Safety Information Mogamulizumab (Genetical Recombination). Pharmaceuticals and Medical Devices Safety Information : No. 298, 30 Jan 2013. Available from: URL: http:/ /www.pmda.go.jp. 803084102
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Reactions 9 Mar 2013 No. 1442
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