New data suggest a potential increased risk of phenytoin or fosphenytoin-induced serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) in patients with the human leukocyte antigen allele, HLA-B*1502.
Update to FDA’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. One large study of zoledronic acid showed a statistically significant increase in the rate of serious atrial fibrillation events. However, across all studies involving 19,687 patients treated with bisphosphonates, no clear association between bisphosphonate use and serious or non-serious atrial fibrillation was observed.
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Ongoing safety review to evaluate increased risk of stroke in patients taking tiotropium bromide. Preliminary findings from the UPLIFT trial showed that there was no increased risk of stroke with the drug in comparison to placebo.
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