Aug 18 (Reuters) - Japanese regulators told Boehringer Ingelheim to issue a strong warning to physicians of potentially deadly bleeding as a result of use of its stroke prevention pill Prazaxa (aka Pradaxa), the first in a promising new class of medicines.
The country's health ministry MHLW said in a so-called Blue Letter earlier this month that between March 14 and Aug. 11, 81 of the almost 64,000 mainly elderly patients taking the Prazaxa pill suffered heavy bleeding, leading to five deaths.
That would be equivalent to about one in 330 patients suffering serious bleeding, mostly in the digestive tract, over a one-year period.
The ministry said in the letter that the unlisted German company needs to tell doctors about these risks and that a lower dose may have to be given to certain patient groups, such as those over 70 or with kidney damage.
Friday, August 19, 2011
Japan warns on Boehringer's Prazaxa / Pradaxa | Reuters
via reuters.com
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