News & Views
DABIGATRAN DEATHS PROMPT JAPANESE SAFETY ADVISORY
Dabigatran has the potential for serious adverse events, according to a safety warning issued recently by the Japanese Ministry of Health, Labour and Welfare after the deaths of five patients.
The advisory cites 81 cases of serious side effects since the drug’s Japanese launch in January. Boehringer Ingelheim has advised physicians to carefully monitor for signs of renal impairment or abnormal bleeding, recommending renal-function tests before and during treatment.
The company is now working to ensure that labeling gives patients all relevant information on the drug’s benefits and risks. Warning is particularly focused on elderly patients and those with risk factors for bleeding.
Published on: September 7, 2011
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