Safety profile of oseltamivir during the 2009 influenza pandemic.

PURPOSE: This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.
METHODS: Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) for USA and Japan only, as exposure data in other countries were collected inconsistently. Events with significantly higher reporting during the pandemic (lower bound of 95%CI for crude rate ratio >1) were analyzed further.
RESULTS: Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 events) and 62.0 million (8387 cases, 12,749 events), respectively. AEs with significantly higher reporting during the pandemic were generally consistent with influenza and its complications and/or with the circulation of a novel virus strain. As might be expected in a pandemic, mortality increased (crude rate ratio, 2.83; 95%CI, 2.23-3.59) versus the prepandemic period. Medical review of serious AEs (fatal or non-fatal outcome) found that most were consistent with pre-existing risk factors, underlying disease, and/or progression of influenza or its complications. Analysis of the remainder did not suggest a causal link with oseltamivir. A review of AEs in previously underexposed subpopulations did not support an association with oseltamivir.
CONCLUSIONS: During the first 8 months of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir were consistent with the drug's labeled safety profile, underlying medical conditions, or infection with the pandemic virus.