At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines, and we take any allegations regarding the science, safety and efficacy of those medicines extremely seriously.
More than five years ago, when lawsuits started to be filed involving our blood thinner, XARELTO® (rivaroxaban), we took a close look at what was being alleged. We found that the label clearly communicated XARELTO®’s benefits and risks, and that claims plaintiffs made about the medicine did not square with the facts.
Based on years of data from hundreds of thousands of patients, we know XARELTO® has been proven safe and effective. It is the most studied medicine in its class in the world today and has been prescribed more than 40 million times. The U.S. Food and Drug Administration (FDA)-approved labeling for XARELTO® has always appropriately informed physicians of the information that they need to make treatment decisions with their patients.
From the outset of the litigation, we have defended ourselves – and we have been successful. All six cases that proceeded through trial were decided in our favor.
Now, we have reached a settlement without any admission of liability, which will end significant XARELTO® litigation activity in the United States. Given our success at trial and our confidence in the medicine, you might be wondering why we have settled.
Let us explain some of the reasons we believe this is the right thing to do for patients and their doctors:
- Even in the face of meritless allegations, and even while winning in court, complex litigation demands an enormous amount of time and resources. Because of this litigation, our talented scientists and researchers, our employees and many doctors across the country have had to spend numerous hours answering questions from plaintiff lawyers, compiling documents those lawyers have asked for, and otherwise being pulled away from their passion for patient care. As a healthcare company, we want to spend every moment we can improving lives and finding new cures.
- News coverage of the litigation and plaintiff lawyer ads trying to recruit clients to join the litigation have caused confusion and concern among patients. We have all seen these lawyer ads on TV – ads related to XARELTO® have been aired millions of times. The ads frequently contain unsubstantiated, incomplete and misleading claims about the medicine. The concerns these ads cause can create barriers to the critical doctor-patient relationship and complicate decisions about treatment options.
- The consequences of this lawyer advertising can also be deadly. Throughout this litigation, we have received independent reports of deaths, strokes and other adverse consequences due to patients viewing plaintiff lawyer advertising and stopping their prescribed anticoagulant medications. With a settlement, it is our hope that plaintiff lawyer ads about XARELTO® will significantly diminish, and that this will give doctors the confidence to continue making the appropriate care decisions for their patients.
What’s the bottom line? We stand behind XARELTO® and are eager and excited to move forward. We continue to support studies that are exploring the potential of XARELTO® to treat new areas of unmet medical need. And we remain committed to the millions of patients worldwide who have been prescribed XARELTO®.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to:
- reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
- treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
- reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
- help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery
XARELTO® is also used with low dose aspirin to:
- reduce the reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)
It is not known if XARELTO® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
XARELTO® may cause serious side effects, including:
- Increased risk of blood clots if you stop taking XARELTO®.
People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.
Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.
If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
- Increased risk of bleeding. XARELTO® can cause bleeding which can be serious, and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop.
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
- Aspirin or aspirin-containing products
- Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin®, Jantoven®)
- Any medicine that contains heparin
- Clopidogrel (Plavix®)
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
- Other medicines to prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
- Unexpected bleeding or bleeding that lasts a long time, such as:
- Nosebleeds that happen often
- Unusual bleeding from gums
- Menstrual bleeding that is heavier than normal, or vaginal bleeding
- Bleeding that is severe or you cannot control• Red, pink, or brown urine
- Bright red or black stools (looks like tar)
- Cough up blood or blood clots
- Vomit blood or your vomit looks like “coffee grounds”
- Headaches, feeling dizzy or weak
- Pain, swelling, or new drainage at wound sites
- Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
- A thin tube called an epidural catheter is placed in your back to give you certain medicine
- You take NSAIDs or a medicine to prevent blood from clotting
- You have a history of difficult or repeated epidural or spinal punctures
- You have a history of problems with your spine or have had surgery on your spine
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
- XARELTO® is not for people with artificial heart valves.
Do not take XARELTO® if you:
- Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
- Are allergic to rivaroxaban or any of the ingredients of XARELTO®.
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:
- Have ever had bleeding problems
- Have liver or kidney problems
- Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.
- Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
- If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.
- Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO®works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”
HOW SHOULD I TAKE XARELTO®?
- Take XARELTO® exactly as prescribed by your doctor.
- Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
- Your doctor may change your dose if needed.
- If you take XARELTO® for:
- Atrial Fibrillation that is not caused by a heart valve problem:
- Take XARELTO® 1 time a day with your evening meal.
- If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- Blood clots in the veins of your legs or lungs:
- Take XARELTO® 1 or 2 times a day as prescribed by your doctor.
- For the 15-mg and 20-mg doses, XARELTO® should be taken with food.
- For the 10-mg dose, XARELTO® may be taken with or without food.
- Take your XARELTO® doses at the same time each day.
- If you miss a dose:
- If you take the 15-mg dose of XARELTO 2 times a day (a total of 30 mg of XARELTO in 1 day): Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
- If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- Hip or knee replacement surgery:
- Take XARELTO® 1 time a day with or without food.
- If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral arterial disease:
- Take XARELTO® 2 times a day with or without food.
- If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
- If you have difficulty swallowing the XARELTO® tablet whole, talk to your doctor about other ways to take XARELTO®.
- Your doctor will decide how long you should take XARELTO®.
- XARELTO® may need to be stopped, if possible for one or more days before any surgery or medical/dental procedure. If you need to stop taking XARELTO® for any reason, talk to your doctor to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribed it to you. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
- Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
- If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
- The most common side effect of XARELTO® was bleeding.
- See “What is the most important information I should know about XARELTO®?”
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban. For more information about XARELTO®, visit www.xarelto.com.