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U.S. Department of Health and Human Services


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Drug Safety and Availability

Drug Safety Communications - Volume 2, Number 1, 2009

Date Product(s) Safety Issue and Link
November 24, 2008 Phenytoin (Dilantin, Phenytek, and generics) and Fosphenytoin Sodium (Cerebyx and generics) 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.
November 12, 2008 Bisphosphonates [alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel with Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa)] 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.
October 7, 2008 Tiotropium bromide
(Spiriva HandiHaler)1
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.
September 26, 2008 Epoetin alfa [Eprex (not marketed in the US)]1 Ongoing safety review to evaluate increased mortality in patients receiving epoetin alfa in a German clinical trial which studied the functional outcomes of patients after an acute ischemic stroke. Eprex is a member of the class of erythropoiesis stimulating agents (ESAs) that are approved by FDA for use in the treatment of anemia in certain patients. In a clinical trial involving 522 adult patients with a middle cerebral artery distribution ischemic stroke, there were more deaths in the epoetin alfa arm vs. the placebo arm (16% vs. 9%) over the first ninety days after the start of the trial.
September 4, 2008 Tumor Necrosis Factor (TNF) Blockers [infliximab (Remicade), etanercept (Enbrel), adalimimab (Humira), and certolizumab (Cimzia)] Alert informing healthcare professionals about the risk of histoplasmosis and other invasive fungal infections in patients taking TNF blockers. These infections are not consistently recognized which may lead to delays in treatment and, in some cases, fatalities. FDA has asked manufacturers of each drug to highlight the risk in the Boxed Warning and Warnings sections of the products’ labeling and Medication Guide.


  1. Early Communication about an Ongoing Safety Review.