MSology Library – Drug safety issues
Drug safety issues
PML (progressive multifocal leukoencephalopathy). This is the most recent published estimate of the risk of PML in people treated with Tysabri.
– Risk of natalizumab-associated progressive multifocal leukoencephalopathy. Bloomgren and colleagues. N Engl J Med 2012;366:1870-1880. www.nejm.org/doi/pdf/10.1056/NEJMoa1107829
– Multiple sclerosis, natalizumab, and PML: helping patients decide. Rudick RA. Cleve Clin J Med 2011;78 Suppl 2:S18-23. Some issues to consider when deciding whether or not to start Tysabri. From the lead author of the SENTINEL study of Tysabri. www.ccjm.org/content/78/Suppl_2/S18.full.pdf+html?sid=0a67c728-e87d-41be-b56d-f38a0d31f567
NEW – A review of the JC virus that causes PML. Diotti and colleagues. Clin Dev Immunol 2013;2013:967581. www.ncbi.nlm.nih.gov/pmc/articles/PMC3708391/pdf/CDI2013-967581.pdf
Pregnancy and MS therapies (fingolimod)
– Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review. Lu and colleagues. Neurology 2012;79:1130-1135. A review of 15 studies looking at outcomes in people exposed to an interferon, Copaxone or Tysabri during their pregnancy. www.ncbi.nlm.nih.gov/pmc/articles/PMC3525300/pdf/znl1130.pdf
– Pregnancy and fetal outcomes after glatiramer acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study. Giannini and colleagues. BMC Neurol 2012;12:124. The effect of Copaxone on pregnancies. www.ncbi.nlm.nih.gov/pmc/articles/PMC3487812/pdf/1471-2377-12-124.pdf
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