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No Antodote for Extensive Bleeding from Pradaxa

Written by Xarelto Helpline on . Posted in Xarelto News

From the standpoint of a Geriatric social workers the " no antidote" with Pradaxa can be very serious as seniors may need emergency surgery from falls. I am exteremely concerned about this with Pradaxa.

One risk of Boehringer Ingelheim's blood thinner Pradaxa  includes a very stern warning. Japanese regulators have asked the German company to notify doctors about potentially deadly bleeding in some Pradaxa patients, Reuters reports. Doctors need to be warned not only about the bleeding risks with the drug Pradaxa but also, that there's no antidote to counteract bleeding if it starts. This is a serious and dangerous side effect. Can you imagine being in a serious auto accident while on Pradaxa. I simple incident could become deadly. Is it safe to assume there will never be a need to force the blood to clot quickly.

With warfarin, , bleeding can be quickly treated with vitamin K. Neither Pradaxa nor any of the others in a new class of warfarin alternatives has a similar antidote. This new generation of drugs includes Xarelto, marketed by Bayer and Johnson & Johnson ($JNJ [1]); Eliquis, the Bristol-Myers Squibb ($BMY [2])/Pfizer ($PFE [3]) med that's awaiting U.S. approval; and Daiichi Sankyo's Lixiana.

The lack of an antidote isn't a surprise. Nor is the bleeding risk with Pradaxa; it's clearly stated on the drug's label. The rate of serious bleeding with Pradaxa was 3.3% per year, Boehringer's fact sheet states, compared with 3.6% with warfarin; the rate of GI bleeding was higher with Pradaxa, however, at 1.6%, compared with 1.1% in warfarin patients. Most of the Japanese patients who developed problems had bleeding in their GI tracts. And just because the stats are listed doesn't mean that all doctors are up-to-date on the risks. Physicians tend to push what the drug  representatives tell them to push and give them perks for. They assume if it has problems it would have been removed form the market by the FDA. They see a potential stroke doing much more harm then just bleeding.

Japanese officials suggest that patients older than 70 may need a lower dose of Pradaxa. Currently, the 110-mg dose is recommended for patients 80 and older. Boehringer says it's cooperating with the government on the warning, Reuters says, and that it's in the company's best interest to have the medicine prescribed within the recommended guidelines. The biggest concern I have is for seniors and seniors living alone. Many do not keep good records of medications and can we safely assume that and EMS call to action agaent will know the warnings of Pradaxa and act accordingly. Pradaxa deaths are a big concern for any home health agency and senior caregiver.