Arava (leflunomide)
In Japan, Arava was approved in April 2003 for rheumatoid arthritis.
Soon after that, interstitial pneumonia (IP) s were reported as serious adverse events one after another.
Arava’s registered data for about 2 years indicated extreme adverse event rate as 73 of IP and 25 of death in 5320 cases.
In August 2004, we requested the Ministry of Health, Labour and Welfare (MHLW) and Sanofi-Aventis K.K. in Japan to suspend Arava and re-examine its safety and effectiveness in strictly controlled clinical trials.
We also requested to disclose all case data in detail concerning IP.
There was also a great suspicion about the preferable outcomes in methotrexate intolerant cases, so we tried to disclose evidences about Arava’s superiority.
Thereafter, we also cast doubts on Arava’s dosage schedule, especially on loading dose, because many adverse events happened in loading course.
Our activities are as follows:
2004-08-02
Submission of a written request to the MHLW and Sanofi-Aventis, entitled “A written request on suspension of Arava (leflunomide) and disclosure of all safety data”
2005-05-20
Submission of a written opinion to Sanofi-Aventis,entitled”A written opinion on Sanofi Aventis’s reply”
2007-04-20
Submission of a written opinion and request to Sanofi-Aventis,entitled” A written counterargument and second request on Sanofi Aventis’s reply”
Topics
- YAKUGAI Ombudsperson
- Tie-up Group
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