Does The Apparently High Number Of Side Effects Cases From Germany Thus Far In 2013 Mean There Is Safety Signal, Or Is This All About Nothing
(Posted by Tom Lamb at DrugInjuryWatch.com)
On September 8, 2013 Reuters published this article, "Reports of side-effects from Bayer's Xarelto grow: Spiegel".
The very next day, on September 9, we get this headline from Reuters, "German regulator sees no new risks from Bayer's Xarelto".
So what is it: Do we have an emerging drug safety issue concerning Xarelto, Bayer's relatively new stroke prevention pill, which is also used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)? Or is this a case of misconception and misunderstanding?
The SpiegelOnline version of the underlying September 8, 2013 article "Unwanted side effects: blood thinner Xarelto Bayer suspected" (original in German) starts with this sub-headline, according to the Google Translation tool:
The blood thinner Xarelto is one of the best-selling pharmaceutical products from Bayer. But the criticism of the drug is growing: According to SPIEGEL information to reports of adverse effects and deaths are increasing.
Strictly Confidential, No Obligation.
From the September 8 Reuters article:
Bayer faces a growing number of reports of suspected undesirable side-effects from its stroke prevention pill Xarelto, German magazine Der Spiegel reported, citing data from a federal authority.
There was a total of 968 cases of suspected undesirable side-effects related to Xarelto in the first eights months of 2013, including 72 cases of death, the magazine reported, citing Germany's Federal Institute for Drugs and Medical Devices (BfArM).
This compares to 750 cases of side-effects, including 58 cases of death, for the whole of 2012, the magazine said. BfArM said there was no clear proof of a correlation between the drug and side effects, the report said.
Jointly developed with U.S. peer Johnson & Johnson, Xarelto is one of Bayer's most important new drugs, expected to earn annual peak sales of more than 2 billion euros ($2.63 billion).
In the U.S. market, Xarelto competes with Eliquis, sold by Pfizer and Bristol-Myers Squibb, and with Boehringer Ingelheim's Pradaxa.
The next day's Reuters news report presented the German drug regulator reaction to this Xarelto Der Spiegel magazine article about Xarelto:
The number of reported side effects linked to Bayer's stroke prevention pill Xarelto is below worrisome levels, a German drugs regulator said, responding to a media report highlighting risks from taking the blood thinning drug.
"There is no new risk situation," a spokesman for Germany's Federal Institute for Drugs and Medical Devices (BfArM) said on Monday....
BfArM said that, while the figures were within a range that was to be expected, the regulator would continue to monitor reported side effects.
In both of these September 2013 Reuters articles, a spokesman for Bayer said Xarelto's risk-benefit profile was still intact.
We will continue to monitor the safety profile of Xarelto and report significant developments here.