![]() ![]() It is inexplicable that despite the lack of scientifically robust data on efficacy and safety of Oseltamivir, reputed organizations like World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), EMA, US FDA not only recommended the drug in question for treatment and prophylaxis of influenza but its stockpiling as well. A recent Cochrane review and a series of articles in British Medical Journal (BMJ) have revealed the truth behind oseltamivir success story, which incidentally is one of the highest revenue earners for Roche. Serious adverse events were first reported during post-marketing surveillance from Japan, UK, and subsequently from other places although most of the published articles did not report them. This article takes a comprehensive relook on the subject, and we proceed to suggest some ways and means to avoid a similar situation in the future. Although many reviewers have labeled the Tamiflu saga as a “costly mistake,” the episode leaves us with some important lessons. The recommendations for stockpiling the said drug as given by various international organizations viz WHO have also been put to scrutiny. A recent Cochrane review and related articles have questioned the risk-benefit ratio of the drug, besides raising doubts about the regulatory decision of approving it. Serious Adverse Events, especially neuropsychiatric events associated with Tamiflu started getting reported leading to a cascade of questions on clinical utility of this drug. In 20, the looming fear of pandemic flu led to recommendation by prominent regulatory bodies such as World Health Organization (WHO), Centers for Disease Control and Prevention, European Medicines Agency and others for its use in treatment and prophylaxis of influenza, and it's stockpiling as a measure to tide over the crisis. Majority of them were funded by Roche, which also first marketed and promoted this drug. A number of randomized controlled trials, systematic reviews, and meta-analysis emphasized a favorable efficacy and safety profile. Oseltamivir (Tamiflu), a neuraminidase inhibitor, was approved for seasonal flu by US Food and Drug Administration in 1999.
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