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Blood thinner Xarelto linked to potentially fatal bleeding

The Australian coast | Shine Lawyers

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 on . Last modified: September 21, 2017.

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  • Joy Anne Bourke wrote:

    Please ask people if they have had problems with hair loss, clumps of hair and other minor episodes. My hair loss started about 3 weeks after starting xarelto and though it was normal until big clumps started coming out and then spoke to my Dr and could not find out the reason. I took this for about 5 months with continuously losing hair. I finally when searching and found that it has happened to many people mainly women. My Dr then ran QML to put me back on Warfarin and QML had had previous people come back because of the side effects. I wonder if my problem of veins clotting in lower part and groin, as when noticed lumps appearing I showed my Dr and she contacted my Vascular Specialist immediately and then after going into hospital twice, the first
    time unable to due to vein damaged and the 2nd time had 3 stents placed in. I have lost over half the thickness of my hair and since then which would be around 18 months has never changed and still losing daily. in some cases, it is possible that this would affect the oxygen reaching your hair follicles, which could cause hair loss. It kills the follicles and does not grow back. It has caused me undue stress being anxious all the time.
    Please help with this situation, I have spoken to a few at the markets who had the same problem and their Dr would not take them off. They demanded and finally were taken off.

    • Shine Lawyers wrote:

      Hi Joy,

      Thanks for reaching out and so sorry to hear about your experience. We’ll need more information to help determine the best course of action. A member of our New Client Team will be able to gather more details, talk through the services we offer and let you know if we can help. Contact details are here:

  • Dan Harris wrote:

    Hello, In reference to Xarelto medication I’m a fit 57 year old male, I have been taking 20mg per day since I spent 2 weeks in Hospital with A. Fib, approx 2 months ago, since taking Xarelto I have had symptoms of constant head aches one in particular with a pain level from 1 to 10,would have been a 10, my wife was ready to call an ambulance the pain subsided after an hour i had an extremely sore head for 3 days,I have suffered from vagness, confusion, extreme fatigue tiredness always wanting to sleep and waking up exhausted, and muscle pains, back of thighs, lower back, blurred vision. And a feeling of sun burn on face, lips, and forearms, itchy nose, I have spoken to my Cardiologist who seemed surprised at if any side affects, the same with my G P who went against Cardio Doctors prescription of Xarelto and said stop taking them, I have Googled Xarelto you just can’t stop immediately, this is after My Cardio Doctor saying this will be a life time medication along with my Heart medication Aratac. I have searched sites in America which have noted the dangers of this drug from internal bleeding to death, one site stating 360 deaths and law suits up to 650 million and growing, can’t find much info in Australia, seems like Doctors don’t want to hear me, getting paid too much by BIG FARMA, guess at the present time I’m lucky as I haven’t any worse side affects, bleeding etc, see how I go over next few months.

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