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Third Opinion Requesting the Immediate Suspension of the Avigan °»Observational Study°… in Light of the High Mortality Rate of Patients Treated with Avigan

2021-09-13

On September 13, 2021, Medwatcher Japan submitted a "Third Opinion Requesting the Immediate Suspension of the Avigan °»Observational Study°… in Light of the High Mortality Rate of Patients Treated with Avigan" to the Minister of Health, Labor and Welfare.

On April 19, 2021, the third interim report of the Fujita study was published by the Favipiravir Observational Study Group of Fujita Health University. It shows that the mortality rate was high among Avigan (generic name: favipiravir) users compared to data from registry studies not restricted to Avigan users.

With efficacy, not only has Avigan's efficacy not been shown, but multiple trials including a domestic and a Kuwaiti study have also failed to prove its efficacy.
Avigan had been administered to approximately 10,000 patients under the name of an observational study.

The continued use of an unapproved drug whose efficacy has not been demonstrated, has been shown to have a high mortality rate, and has teratogenic risks should not be allowed in light of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and ethical principles.

So we request the following respectively.
1. The Ministry of Health, Labour and Welfare (MHLW) and FUJIFILM Toyama Chemical Co., Ltd. should immediately discontinue the conditional supply of Avigan to those participating in an observational study by Fujita Health University. Fujita Health University should also immediately stop the enrollment of new patients receiving the drug.
2. MHLW should not approve Avigan for the treatment of COVID-19 without proof of efficacy through rigorous randomized controlled clinical trials and an appropriate assessment of the balance between risks and benefits.

The full text is in the attached document below.
The first and second opinions are also available below.