Higher Bleeding Rates Detected in J&J-Bayer Drug

A heart drug from Johnson & Johnson and Bayer AG was recently proven to be effective in preventing certain blood clots—even though it may cause higher bleeding rates that limit the drug’s effectiveness.

Patients who received the drug, rivaroxaban, experienced bleeding at more than double the rate of those in a group given an anticoagulant and a placebo, according to a study presented at the American College of Cardiology in New Orleans.

Around 8.100 patients participated in the study. Half were given rivaroxaban for 35 days, and the others were given an anticoagulant called Lovenox for 10 days and a placebo for the rest of the study. At 35 days, use of rivaroxaban reduced risk of clots and clot-related deaths to 4.4%, versus 5.7% in the Lovenox/placebo group. Two point eight of rivaroxaban users experienced clinically relevant bleeding at 10 days, and 4.1% at 35 days. The rates for patients in the Lovenox/placebo group were 1.2% and 1.7%.
Rivaroxaban has been commercially available in Europe under the brand Xarelto since 2008. J&J and Bayer are seeking to expand the drug’s availability to the United States and for uses beyond the prevention of blood clots. The U.S. Food and Drug Administration could determine this year on atrial fibrillation and clot-prevention applications for rivaroxaban.

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