FDA Could Approve Xarelto Despite Internal Bleeding Risk

Posted on May 21, 2012

A drug that could help prevent blood clots in certain persons is going to be reviewed on Wednesday, and even though the Food and Drug Administration is cautiously optimistic about its approval, officials still have worries.

Johnson & Johnson is the maker of the drug, which is called Xarelto.  The drug is already on the market, where it’s used to treat persons who are either getting knee or hip replacement surgery or who suffer from an irregular heartbeat.  Now, though, the makers of the drug want to market it as a clot prevention tool in persons who suffer from acute coronary artery disease.

The FDA has conducted its initial review through a drug reviewer, who recommends approval.  This is based on the results of a 15,500 person study in which heart attack, stroke, and death risk were reportedly lowered significantly by the drug’s administration.  However, there are certain risks.  Those who took the drug risked suffering major internal bleeding at a rate three times greater than those who just took a placebo.

In addition, it was found that more than 1,000 people dropped out before the study’s completion.  The FDA is concerned that such a significant drop-out rate and subsequent lack of data from those subjects could be skewing the results in favor of approval.

A panel will convene on Wednesday to debate approval and give their recommendation.  After that, the FDA will consider final approval, which should take place on or before June 29.

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