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Eliquis Side Effects and Usage

What are the known side effects of taking Eliquis?

Both taking Eliquis and stopping Eliquis treatment once it has commenced are associated with numerous side effects, from the relatively minor to the potentially fatal. Eliquis also has been shown to become even more dangerous when taken in conjunction with certain other medications.

Potential Side Effects of Eliquis Treatment

Risk of Bleeding: The risk of bleeding is inherent to all so-called “blood-thinners”, as their purpose is to reduce clotting in the blood. However, certain anticoagulants—the class of anti-clotting agents that includes Eliquis—present more of a bleeding risk than others, particularly when taken along with other anti-clotting medications.

According to the United States Food and Drug Administration (FDA), medications that should not be taken in conjunction with Eliquis, as they may increase the risk of bleeding, include:

• Aspirin or drugs containing aspirin

• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

• Warfarin sodium (Sold under the brand names Coudamin and Jantoven)

• Heparin and heparin-containing medications

• Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)

• Other anticlotting medications

Because Eliquis prevents blood from clotting as it naturally would, it can make otherwise normal bleeding incidents more severe and potentially very dangerous. For example, women taking Eliquis may find that their menstrual bleeding to be heavier than usual, and individuals might notice excessive bleeding from the gums or nosebleeds that occur more frequently and with greater severity.

Did you or someone you know suffer a serious bleeding incident while taking Eliquis? In lawsuits across the country, patients are claiming they were inadequately warned about the very serious risks of bleeding associated with Eliquis treatment. Contact the expert attorneys at TheLawFirm.com now for a free consultation.

The LawFirm.com Sidebar: The Eliquis Bleeding Risk

When one refers to the “bleeding risk” associated with Eliquis, what exactly does this mean? According to the FDA, taking Eliquis can result in:

• Any bleeding incident being more severe and longer-lasting, with the potential to become out of control

• Bruises that form more easily and take longer to heal

• Bleeding from the gums

• Nosebleeds

• Heavier bleeding during menstrual cycles

• Red, Pink, or brown color to urine from the presence of blood

• Coughing up blood and/or blood clots

• Unexplained and/or excessive swelling

• Vomiting blood (or vomit takes on the appearance of “coffee grounds”)

• Headaches

• Lightheadness

• Weakness

Spinal or epidural blood blots / Hematoma. Research has revealed that individuals taking anticoagulants like Eliquis have an increased risk of developing serious complications when suffering a spinal puncture or while underdoing injections to the spinal or epidural area. The result can be the development of a spinal blood clot, a very severe condition that can result in long-term or even permanent paralysis, or hematoma, bleeding in the spinal area.

Spinal strokes. Spinal blood clots are a particularly dangerous form of blood clot that can result in serious conditions such as a so-called “spinal stroke” in which the blood flow to certain areas of the spine is disrupted. Spinal strokes caused by a blood clot that blocks an artery supplying the spinal cord are called ischaemic spinal strokes.

The symptoms of a spinal stroke typically take effect quickly, often within minutes. Early indicators frequently include intense neck and back pain, muscle weakness in the lower body, and bowl and bladder abnormalities. Sufferers of spinal stroke also report unusual symptoms, such as the sensation that something had been tied tightly around one’s torso at the point in the spine where the blood flow has been disrupted.

The potential long-term effects of a spinal stroke are more severe. As a result of blood flow being cut off to vital areas for an extended period of time, spinal stroke can result in paralysis, chronic pain, bowel and bladder issues, sexual dysfunction, and depression.

If you suffered a spinal stroke, spinal blood clot, or spinal hematoma while taking Eliquis, the experienced team of expert attorneys at TheLawFirm.com are standing by now for a free legal consultation.

According to the Food and Drug Administration (FDA), the factors that have been shown to increase the risk of spinal or epidural blood clot include use of an epidural catheter in the spine; the taking of NSAIDs, anticoagulants, or other anticlotting agents; having a history of epidural or spinal punctures; or having previously experienced spinal problems generally.

TheLawFirm.com Sidebar: When Should I Contact My Doctor?

All the information in the world about potential side effects is useless if one does not know the signs to look out for. According to the FDA, those taking Eliquis should seek emergency medical assistance if they notice:

• Pain or tightness in the chest

• Swelling of the face or tongue

• Difficulty breathing, wheezing

• Lightheadedness, fainting

• Unexpected bleeding or bleeding that won’t stop

• Discoloration to the urine

• Red or black coloration to the stool

• Coughing up and/or vomiting blood

• Unexplained swelling or joint pain

• Lightheadedness, headache, fainting

Potential Side Effects of Stopping Eliquis Treatment

Stroke: One of the two Black Box Warnings that the Food and Drug Administration (FDA) has required for Eliquis involves the risk of stroke in those who discontinue Eliquis use without proper medical guidance.

There are many routine instances, such as dental procedures or minor surgeries, in which a patient taking Eliquis may be required to cease taking the drug for a period of time. However, doing so increases the chances that a patient will develop blood clots, which may travel to the brain and cause a stroke. A doctor may be able to prescribe a replacement medication that will hedge the risk of stroke when stopping Eliquis treatment.

Has anyone sued the makers of Eliquis over its side effects?

Yes, a number of lawsuits have been brought across the country by patients (or their family members) who suffered harm as a result of taking Eliquis. Plaintiffs have alleged that Bristol-Myers Squibb and co-defendant Pfizer failed to adequately warn patients and doctors about risks associated with Eliquis use.

In February 2017, the Judicial Panel on Multidistrict Litigation (JPML) consolidated many of these cases into multidistrict litigation (MDL) in the Southern District of New York. To date, many of these cases have hinged on legal technicalities about the interpretation of certain key laws and the interplay of state and federal law in the area of pharmaceutical labeling.

TheLawFirm.com Chronology: Eliquis MultiDistrict Litigation (MDL)

February 2017: The Judicial Panel on Multidistrict Litigation (JMPL) in Miami ordered the consolidation of numerous district court cases from across the country that involve patient’s suing Bristol-Myers Squibb over harms caused by its drug Eliquis. Specifically, most the claims involved allegations that the drug maker failed to warn adequately about dangers of uncontrolled bleeding. The newly created MDL included cases from Arizona, California, Hawaii, Illinois, Kentucky, Louisiana, New York, Pennsylvania, Tennessee, and Texas.

May 2017 – Utts Decision #1: In what would become a significant ruling for the MDL, on May 8, the Court issues an Opinion and Order for the case Utts, et al. v. Bristol-Myers Squibb Co, et al., dismissing the case in its entirety, as urged by the defendant drug companies. In tossing out the suit—which had originated in California and involved California law—the Court ruled that federal law had prohibited the defendants from unilaterally altering the Eliquis label as plaintiffs allege they should have and that this federal law superseded the relevant state law.

Utts Decision #2: In a follow up to its May decision, the Court upheld its earlier ruling to dismiss the Utts case on the basis that federal law in the relevant area supersedes the state law claims on which plaintiffs had relied. Specifically, the Court interprets the federal law as allowing drug makers to modify their drugs’ labels only upon the discovery of new information, which the Court holds has not been demonstrated by the plaintiff.

July 2017 – The Fortner Decision: The Court dismissed the case Fortner v. Bristol-Myers Squibb Co. & Pfizer Inc., relying on the Utts decisions with regards to federal law issues and further ruling that the Eliquis label had been adequate per Tennessee law, under which the case had been brought, setting an unfortunate precedent for Tennessee residents seeking to bring a claim over harms caused by Eliquis.

November 2017: Relying on its two Utts decisions—which held in relevant part that federal law superseded plaintiffs’ state law claims—the Court dismissed from the MDL in their entirety 24 cases that had originated in Delaware. The Court further rejected plaintiffs’ attempts to have their cases remanded back to Delaware district court. Plaintiffs had sought to distinguish their cases from Utts on the basis that their cases relied on different evidence, but the Court ruled that plaintiffs still had failed to demonstrate that new information had been discovered significant enough to allow for a change in the drug’s labeling under federal law.

A day after the ruling dismissing the 24 cases, the Court further ordered that any additional cases wishing to join the MDL must demonstrate to the Court’s satisfaction that the Utts decisions do not apply to their case.

At this time, the Eliquis MDL continues to make its way slowly through the court system, with plaintiffs seeking to distinguish their cases from Fortner and Utts. Specifically, one of the main hurdles facing plaintiffs is the need to prove to the Court’s satisfaction that new information existed sufficient to allow the drug makers to change the Eliquis label under federal law. Significantly, the vast majority of the arguments have centered on the issue of the adequacy of the Eliquis label and not on whether or not Eliquis actually caused the harms at issue, which seems to be all but an agreed upon fact.

Have you or a loved one suffered from uncontrolled bleeding, a spinal blood clot, or other harm while taking Eliquis? The expert lawyers at TheLawFirm.com are standing by, ready to help you navigate the legal complexities of your case. Contact us now for a free consultation.

Source:
United States Food and Drug Administration (FDA)Medication Guide – Eliquis

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Eliquis Antidote

There is reason to be hopeful, however, that an antidote is forthcoming. An antidote is in the works, although the FDA delayed approval of an antidote for Eliquis due to questions with the manufacturing process.

Data presented at a meeting of the European Society of Cardiology suggests the experimental antidote could help save as many as 90% of people with a serious bleeding event from dying.

Portola Pharmaceuticals, who is currently seeking FDA approval for its Factor Xa bleeding antidote AndexXa, has released interim data of an ongoing study.

The drug caused an 89% reduction in the blood-thinning effects of Xarelto, and a 93% decrease in the effects of Eliquis. Overall, 79% of patients experienced an “excellent” or “good” stop in internal bleeding within 12 hours of being given AndexXa.

While these results show thousands of patients could be saved from injury or death, the antidote could be months or years away from approval due to FDA delays. It is alleged in lawsuits alleged that the makers of Eliquis didn’t fully warn patients of the risks, putting more people at risk.

We are sure that the makers of Eliquis are eager to have AndexXa approved because it would give doctors more confidence in prescribing their blood thinners. In the meantime, please contact the attorneys at TheLawFirm.com if you have a serious bleeding incident while taking Eliquis.

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