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Anti-Coagulation Medications May Cause Serious Side Effects
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By Heidi Turner
Anti-coagulation lawsuits have been filed against the makers of certain anti-coagulation medications alleging the makers of those medications did not carry adequate warnings about the risks of anti-coagulation side effects. Side effects associated with certain blood thinners include an increased risk of life-threatening uncontrolled bleeding.
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Anti-coagulation medications (also known as blood thinners) are used to prevent blood clots, which can result in deep vein thrombosis, pulmonary embolism and stroke. Because they prevent blood from clotting, however, patients may develop uncontrolled bleeding—including internal bleeding—from minor injuries. The longest-used blood thinner is Warfarin, known by the brand name Coumadin.
Like newer-generation anticoagulation medications, warfarin has been associated with an increased risk of uncontrolled bleeding. Unlike newer anticoagulation drugs, however, warfarin has an antidote, so patients who develop bleeding problems and seek medical attention may have the effects of warfarin reversed.
Among the medications that are included in the class of anticoagulation drugs are Pradaxa, Xarelto, Zontivity, Eliquis and Savaysa.
Newer-generation anticoagulation medications may also be associated with an increased risk of uncontrolled bleeding. Unlike warfarin, they do not currently have an accepted antidote meaning patients who suffer a bleeding event may not be able to reverse the effects of the event, potentially creating a life-threatening situation. Some of these medications have been marketed as easier to use than warfarin because their makers claim patients do not require blood level monitoring.
Newer-Generation Anticoagulation Medications
Lawsuits filed against the makers of some anticoagulant drugs allege either that the drug did not carry an adequate warning about the risks or that the drug was marketed as superior to warfarin when there was no antidote.
Pradaxa's label does carry a warning about the increased of bleeding events in patients. Some concerns have been raised, however, that Pradaxa was marketed as being superior to warfarin, even without an antidote.
The Pradaxa label does include a warning about the increased risk of bleeding events in patients. The concern, however, is that Pradaxa was allegedly marketed as being superior to warfarin even though there was no antidote to the uncontrolled bleeding.
In May 2014, Boehringer Ingelheim announced a $650 million settlement to resolve around 4,000 lawsuits alleging patients were seriously harmed by the use of Pradaxa.
Xarelto has also been reportedly linked to an increased risk of bleeding side effects. Lawsuits have been filed against the maker of Xarelto, but as of August 2014 fewer than 10 lawsuits have been filed.
In 2014, Johnson & Johnson and Bayer announced that the FDA sent a complete response letter regarding Xarelto, rejecting the companies' application to expand the use of Xarelto to include new indications. The FDA had previously rejected other applications to expand the use of Xarelto as well.
Attorneys expect that more Xarelto lawsuits will be filed alleging patients were not properly advised of the risks associated with the medication.
Other newer-generation anti-coagulant medications include:
Zontivity, known generically as vorapraxar, is a new drug approved for use in 2014. Early trials of the drug were reportedly changed and one trial was reportedly stopped prematurely because the trials suggested an increased risk of severe bleeding or intra-cranial hemorrhage (bleeding). According to the FDA, the drug will carry a boxed warning concerning the risk of intra-cranial hemorrhage.
The Alere INRatio and INRatio2 PR/INR Professional Monitoring Systems are used by healthcare professionals to monitor the effects of warfarin on a patient's clotting time. The systems determine the International Normalized Ratio (INR) of the patient's fresh capillary whole blood, which shows how quickly the patient's blood clots.
Alere INRatio and INRatio2 PT/INR Professional Monitoring System
On December 8, 2014, Alere announced a class 1 recall in the form of a correction letter, warning that certain medical conditions should not be tested with the INRatio and INRatio2 systems. In its announcement, Alere noted that some medical conditions might result in incorrect results, specifically, inaccurately low INR results. Conditions include anemia with hematocrit less than 30 percent, conditions with elevated fibrinogen levels, chronic inflammatory conditions or severe infections. Inaccurate INR results could lead to a doctor not making necessary warfarin dosing changes, putting the patient at risk of a bleeding event.
Patients on certain anticoagulant medications require regular testing to ensure their blood maintains its ability to clot in the case of injury. Doctors who do not provide adequate testing for patients who require it may be liable for medical malpractice if their patient suffers an uncontrolled bleeding event.
Anticoagulant Medical Malpractice
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ANIT-COAGULATION MEDICINE LAWSUITS
Alere INRatio and INRatio 2 Recallnoting some patients could receive inaccurate results.
Eliquis anticoagulant linked to an increased risk of uncontrolled bleeding
Zontivity side effects include an increased risk of major bleeding, including intracranial hemorrhage
Xarelto Blood Thinner Side Effects Increased risk of bleeding events
Bleeding Deaths Associated with Pradaxa
Coumadin (Warfarin) allegedly causing side effects including birth defects and brain damage.
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New Orleans, LA: The second bellwether Xarelto lawsuit in multidistrict litigation over allegations of Xarelto bleedout in association with the new age blood thinner has gone, like the first, to the defendant. While this may prove disappointing to litigants alleging the anticoagulant is unsafe, there are still two more bellwether trials to roll out later this year, with some 15,000 cases in the federal multidistrict litigation pipeline housed in New Orleans. Additional cases are percolating at the state level in Philadelphia [READ MORE]
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i was on lovenox for a year 60mg 2xday for a dvt it cleared up but lovenox ruined my low back i can barely stand up when walking can't walk far outside due to my back and never received a inr test while on the lovenox only now that i take warfirn i have to be on omeprpzele also and lovenox ruined my kidney function
Out of all the comments posted, it's my comment or storyline; that should hit this nation/country like a ton of bricks, symbolic to a category five hurricane event! My OB/GYN doctor, and surgeon allowed me to, walk around with a whole: blood clot(DVT) for several months, prior to detecting its existence(Aug of 2009)! Before that I had, undergone major surgery in May of 09(for urine fibroids,& heavy bleeding:davanci laparoscopy vaginal hysterectomy). Due to extreme emotional trauma, events, and ongoing agonizing right side pelvic/flair pains! My overall health had taken, a turn for the worst, on June 3, 09; which caused a category five nervous breakdown, and emotional disturbance! I absolutely and positively never bounced back, and nor gotten passed: my massive neuro-degeneration of health declination, and crisis! Within that same timeframe, the following health problems emerged: frequent pelvic pains, anxiety, PTSD, emotional trauma, blood pressure abnormalities, speech complications, impairment, loss of mobility issues, anemia, restlessness, weaknesses, TIA'S, headaches, and possibly slight mild strokes incidents! Several neuro-diagnostic images were administered: before, during, and after the surgery, as well as the detection of the DVT/Blood Clot existence! However,the images fail to detect the, blood clot existence; which had a lot to do with, and contribute to the ongoing agonizing, right side pelvic/flair pains issues, and extremities! I was hospitalized in Aug of 09, once when the images detected, that the thrombosis or blood clot did exist(upper right side pelvic area)! At that point, I was administered low doses of heparins, and put on warfarin: upon being discharged, from the hospital! Warfarin was in use or taken: between Aug/09, to July/10! As a result of insufficient, inadequate, and intentional wanton type: malicious, negligence, neglect, intentions/motives, refusals, errors, oversights, concealment, malpractices, misconduct, perjury, denials, defamation, recklessness, carelessness, ongoing attacks, conspiracy to commit murder, or form of homicide to demise my health altogether, disinterest, disconnection, mistreatment, misdiagnosis, lack of attention, and gravely wanton type endangerment! It left this one board certified citizen of the USA, in this condition, and statehood! Speechless, severely harmed,injuried, weakened, almost permanent disable, stricken, afflicted, torn, humiliated, emotionally traumatized, hurting, grasping for air, helpless, unnecessary suffering, extreme off/on pains, and possibly suffer unprecedented life-threaten permanent damage control; in all three of these necessity organs: the brain, blood, and immune system! After seven years, and counting, I still haven't been formally diagnosed, or given any sort of precise diagnosis, answers, compensation, legal counsel, representation, assistance, concrete evidence, explanation, reasons, etiology, apology, and no closure surrounding, about my massive neuro-degeneration of health declination, and crisis!
marlene rice smith
my husband used lovenox and had a brain bleed what is the deadline to see if there is a class action suit
In 2012 I was prescribed self-injections of Lovenox after having gastric bypass surgery. Several days after being home and injected myself I collapsed and had a severe loss of blood through my rectum. I had to be given a blood transfusion and was hospitalized for seven days afterwards. I was never given a reason as to WHY this happened or anything. The only thing I received is a large hospital bill and severe anemia that I still suffer with and fear that I'm ok from the blood transfusion.
I was pregnant in 2015 and prescribed Enoxaparin Sodium (generic Lovenox) 100mg injections every 12 hours. My doctor checked my Blood levels they day she started me at 10 weeks, and only every 8 weeks after that(total of twice while on the Lovenox) and at 29 weeks along I was coughing, and tore the Rectus Sheath muscles from my abdominal wall. It sent me to the Emergency Room, which within 12 hours lead to the premature delivery of my daughter, who in turn died at 3 weeks from being born too soon. I still suffer from having injected this blood thinner. I have big knots under my skin that has turned my skin dark, like it died off. I bruised huge while on it. After bleeding for 12 hours and lost about 2 liters of blood, I was in the ICU for 18 hours, a total hospital stay of 8 days. Is this something you can help me with?
I had total hip replacement in 2013... I was given lovenox for self injection into my abdomen... In 2014 I had my other hip replaced... I am 48, diagnosed with aseptic vascular necrosis... I wasn't given ANY kind of thinner, or coagulant on my second hip... I am permanently on omeprozale due to the taken of lovenox... If I don't take one, a simple glass of water can give me unbearable heartburn... At times I have experienced bleeding during bathroom events(fecal)... Is this involved in your class action???
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