Clinical trials and post-market experience have linked widely used blood-thinning drug Xarelto and similar anticoagulants to incidences of major bleeding, some of which have been fatal.
Xarelto works to reduce the tendency of blood to form clots and may be prescribed to prevent or treat blood clots in the brain, lungs, legs, or veins. Patients who have had a total knee or hip replacement may be prescribed Xarelto due to their vulnerability to blood clot formation.
The safety and effectiveness of Xarelto has been examined in a number of independent clinical studies. While these studies can vary significantly in what they are testing, several studies have found more bleeding events occurred with Xarelto patients than those on placebo or other drugs being tested.
The Therapeutic Goods Administration (TGA) approved Xarelto for sale in Australia in 2008 and since then, the drug’s popularity has increased significantly. Medical giants, Bayer and Johnson & Johnson subsidiary Janssen-Cilag, have marketed Xarelto as a safe and effective replacement for Warfarin, the market leader for anticoagulants for many decades.
In 2013, the TGA issued a safety advisory about three anticoagulants, including Xarelto, in which doctors were reminded of the dangers of bleeding events associated with the use of these drugs. Unlike Warfarin, an effective antidote to Xarelto has yet to be approved for human use. The effect of Warfarin can be reversed by a dose of Vitamin K however there is no simple antidote that can be administered if a bleeding event occurs as a result of Xarelto. The result is that patients may be at an increased risk of harm as a medical professional cannot easily reverse the effect of the drug.
Hundreds of lawsuits relating to the drug have been filed and are currently awaiting trial. The claims in these lawsuits centre around allegations that the manufacturers failed to warn about the potential risks associated with Xarelto and that there is no effective antidote for Xarelto induced bleeding events as there is for Warfarin. In many of these cases, it is argued that the manufacturers were negligent in their testing of Xarelto and in their design of material which warned patients and doctors of the risks associated with Xarelto. If the manufacturers are found to have been negligent in their testing of the drug or in the warnings they provided to patients, they may be liable for injuries and losses suffered by Australian patients.
The US Food and Drug Administration (FDA) in 2014 required the manufacturers to change their product labelling to better reflect the risks of bleeding associated with the drug and the availability of an antidote. The TGA in Australia has not publicised that it has taken any similar action.
Click to read more about Eliquis (Apixaban), another blood thinner linked to fatal bleeding
Click to read about Product Liability claims
Written by Shine Lawyers. Last modified: October 16, 2018.