The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) Japan, have announced that the package inserts for olmesartan medoxomil containing products (Olmetec® and Rezaltas®) should be revised to include interstitial pneumonia as an adverse drug reaction.
Olmesartan is indicated to treat hypertension. A total of seven cases of interstitial pneumonia in patients treated with olmesartan medoxomil have been reported in Japan during the previous three years. No patient mortalities have been reported.
MHLW/PMDA have concluded that revision of the package insert is necessary.
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