Japan adds serious liver condition to list of Opdivo side effects
Japan’s medicines regulator has ordered that the gastroenterological condition primary sclerosing cholangitis (PCS) be added as a potential side effect of Opdivo (nivolumab).
The blockbuster immuno-oncology drug is marketed in Japan and other parts of Asia by Ono Pharmaceutical (TYO: 4528), after a 2014 development and commercialization deal with Bristol-Myers Squibb (NYSE: BMY).
The Ministry of Health, Labor and Welfare (MHLW) ordered the update to the list of Adverse Drug Reactions on the drug’s label on July 4, Japanese press reports.
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