German regulators see no new risks with Bayer's Xarelto

German regulators have responded to Der Spiegel's questions about Xarelto side effects. Answer? The Federal Institute for Drugs and Medical Devices (BfArM) sees no new red flags for patients using the clot-fighting drug developed by Bayer and Johnson & Johnson ($JNJ).

"There is no new risk situation," an agency spokesman told Reuters after Der Spiegel reported that the number of side-effect reports and deaths in Xarelto patients had been growing. For the first 8 months of 2013, there were 968 side-effect reports, including 72 deaths, compared with 750 side-effect reports and 58 deaths during the whole of 2012.

BfArM said the numbers were within the expected range. Anticoagulant drugs come with an increased risk of bleeding, including fatal cases. Regulators typically consider the rate of serious side effects in clinical trials when weighing similar reports after a drug hits the market.

The use of Xarelto has been growing in the U.S., where J&J handles its marketing, and in Europe, where Bayer is in charge. The drug brought in €322 million for Bayer last year, or about $425 million; by the end of the first half of 2013, Bayer's Xarelto sales had hit €374 million, or almost $500 million.

Doctors and regulators are keeping an eye on Xarelto and several other drugs that are marketed as alternatives to the old standby anticoagulant, warfarin. Boehringer Ingelheim's Pradaxa was first in the group to gain approval for stroke prevention in patients with atrial fibrillation, and so it was first to capture a big share of that market. Side effect reports for that drug have been mounting with increased use, but after reviewing the numbers, the FDA concluded that Pradaxa remains as safe or safer than warfarin if it's properly administered. Though warfarin is difficult to dose and interacts with other drugs and even foods, its effects are easily counteracted with Vitamin K, while its new replacements, including Xarelto, do not yet have an easy antidote.

- read the Reuters news

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