Harsher Demands on Methotrexate Labeling in Japan
2008-12-01
The labeling of methotrexate in Japan has been scrutinized and manufacturers have required to release stricter labeling under the pressure from Japan's Ministry of Health, Labor and Welfare (MHLW). Methotrexate is often seen as the treatment to rheumatoid arthritis (RA), reported Pharma Japan.
The new labeling is intended to be user-friendly. It is design to educate patients to consume the drugs during the appropriate period. And it is necessary to take five-day breaks from using the drug.
The MHLW launched a survey on 242 cases of accidental drug misuse. The data organized by the Japan Council for Quality Healthcare (JCQHC) found that three of the drug-users had associated with the misuse of methotrexate. Some similar misuses had occurred before the release analysis.
It is estimated that there are seven manufacturers marketing methotrexate for RA in Japan where the drug originator is Wyeth's (U.S.) Rheumatrex.
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