Brigette Honaker  |  August 25, 2019

Anticoagulant Drugs Overview

Anticoagulant drugs are blood-thinning medications commonly prescribed to treat and prevent blood clots and other cardiac complications.

Although anticoagulants are sometimes called “blood thinners”, they do not actually thin the blood. Instead, these drugs prevent the blood from clotting by affecting numerous parts of the coagulation process.

There are numerous anticoagulants available in the U.S., including Eliquis (apixaban), Lovenox (enoxaparin), Lixiana (edoxaban), Pradaxa (dabigatran), Xarelto (rivaroxaban), and Coumadin (warfarin). Warfarin has been on available the longest and is more trusted than some of the modern blood thinners.

Anticoagulants are approved to treat and/or prevent the following conditions:

  • Deep vein thrombosis (DVT): clots that form in the deep veins of the legs
  • Heart attack
  • Stroke
  • Pulmonary embolism: clots that reach the lungs and create blood vessel blockages
  • Blood clots
  • Stent thrombosis
  • Clotting during atrial fibrillation treatment

 

Different anticoagulants may only be approved to treat certain conditions based on testing done by the manufacturer. In some cases, patients only need to be on blood thinners for a short time. Other patients with chronic conditions may have to be on anticoagulants long term.

Side Effect of Anticoagulants

The primary side effect of anticoagulant drugs is increased bleeding. This can be mild and cause easy bleeding and bruising when patients are injured. However, this can also lead to severe bleeding side effects including:

  • Blood in urine
  • Blood in bowel movements
  • Severe bruising
  • Nosebleeds
  • Bleeding gums
  • Vomiting blood
  • Coughing up blood
  • Heavy menstrual cycles

 

Severe, uncontrollable bleeding is a severe side effect of anticoagulant drugs and requires immediate medical attention.

Other side effects of anticoagulant drugs may include: diarrhea, conspiration, indigestion, dizziness, headaches, rashes, itchy skin, hair loss, and jaundice.

Anticoagulant Recalls & FDA Announcements

The FDA has been aware of severe bleeding events with anticoagulants but approved the drugs after determining that the treatment benefits outweighed the risks.

More recently, modern blood thinners such as Pradaxa and Xarelto became safer when the FDA approved reversal agents. Unlike warfarin, which can be easily reversed by flushing the body with vitamin K, modern blood thinners were approved with no reversal agent.

When uncontrollable bleeding occurred previously, patients were treated with blood transfusions and other management techniques while the anticoagulant worked its way out of the system. Now that modern blood thinners have readily available reversal agents, their safety profiles have been significantly improved.

Lawsuits & Settlements Regarding Anticoagulants

Although modern anticoagulant drugs are safer now that the FDA has approved reversal agents, consumers claim to have been harmed in the past by blood thinners causing excessive bleeding. Some patients filed lawsuits against drug manufacturers, claiming that the manufacturers failed to sufficient warn about the life-threatening bleeding risk associated with the drugs.

In April 2019, Xarelto manufacturers Bayer and Johnson & Johnson agreed to pay $775 million to resolve 25,000 anticoagulant lawsuits against them. According to a statement from Bayer, the companies did not admit wrongdoing. Instead the settlement “allows the company to avoid the distraction and significant cost of continued litigation.”

Lawsuits have also been filed against Pradaxa and Eliquis manufacturers for similar issues.

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