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Pradaxa: Health Benefits & Side Effects of Pradaxa

By Jemima Faith

PradaxaDescription of Pradaxa

Pradaxa (dabigatran) is a medicine used to prevent or treat blood thinner or to prevent stroke in patients who suffer atrial fibrillation. At the period of atrial fibrillation, the heart’s movements are weak and erratic. Since blood does not move as effectively, it can form clots around the heart. This blood build-up (clot) significantly raising the risk of stroke in patients with atrial fibrillation. In fact, studies show that the danger of stroke is four to six times higher in atrial fibrillation patients. Dabigatran etexilate mesylate (the active component in Pradaxa) is a yellow-white to yellow substance. Pradaxa capsules are supplied in 75, 110, and 150 mg strengths for oral prescription.

 

Possible side effects of Pradaxa

Pradaxa side effects can vary from mild to life-threatening. Pradaxa side effects have been observed in others. The U.S. Food and Drug Administration (FDA) have documented thousands of reports associated with Pradaxa usage. Among the most dangerous side effects Pradaxa is uncontrollable or tremendous bleeding. This Pradaxa side effect has been proven fatal for hundreds of patients. It is vital that all users are aware of Pradaxa side effects. Physicians and dentists should be informed that a patient is taking a blood thinner such as Pradaxa before surgeries or dental work begins. It is advised to seek immediate medical attention if patients experience side effects Pradaxa.

Among the most common side effects Pradaxa, we have the followings:

  • confusion,
  • Nose bleeds, and bleeding from minor cuts and scraps.
  • Bruising,
  • vision changes,
  • severe pain in the stomach or abdomen
  • Slurred speech and weakness in only one side of the body should also be treated quickly. These signs can indicate severe bleeding.
  • Heartburn
  • Indigestion
  • Nausea
  • Stomach upset or pain 
  • Mild skin itching or rash
  • Unusual bruising
  • Brown or pink-colored urine
  • Vomit that ressembles coffee grounds
  • Severe swelling or joint pain
  • Dizziness, severe headaches or weakness

However, the other risks linked to Pradaxa uses cannot be taken lightly. Serious side effects of Pradaxa include:

  • uncontrollable bleeding
  • liver failure
  • Heart attack or even death.

Among the severe side effects Pradaxa, uncontrolled bleeding has been the most frequently reported. This uncontrolled internal bleeding can be life-threatening and cause problems in the brain and central nervous system that are just as detrimental as a stroke, the entire purpose of taking the Pradaxa medication. If you experience signs of internal bleeding, you may want to consult your doctor immediately. If caution is not taken, the side effects of Pradaxa from bleeding can be very horrendous.

 

Signs of internal bleeding include:

If you have taken Pradaxa, Xarelto, Eliquis, or any other drug in the class of blood thinners you may be at risk of internal bleeding. Observing the signs as early as possible could save your life. Take a look at these signs of internal bleeding:

  • Pain in the Abdomen: If you have pain or tenderness anywhere between the chest and groin, it may be a symptom of internal bleeding.
  • Vomiting Blood: Regurgitating accompanied with blood stains could be one of the signs of internal bleeding. The blood is usually mixed with food, but sometimes it could just contain blood.
  • Blood in the Stool: Blood in the stool is usually a sign of bleeding in the digestive system. Sometimes tomatoes and beets can cause the stool to appear reddish, and sometimes blood in the stool can make it look darker, almost black in color due to an upper bleeding position. Therefore, a stool test performed by a doctor will be able to confirm if there is blood in the stool or not and consequently, this reveals the side effects of Pradaxa
  • Blood in Urine: Bloody urine is another sign of internal hemorrhage. Hematuria is the medical diagnosis for blood in the urine and it is often triggered by kidney problems, urinary tract infections, injury to the bladder, bladder cancer, or kidney failure.
  • Coughing Blood: Coughing blood may mean respiratory system problems. This condition is called Hemoptysis and is often a fusion of mucus stained with blood and sometimes consists of air from the lungs causing bubbles in the substance.
  • Vaginal Bleeding: Heavy, prolonged, and irregular menstrual periods could be other symptoms of internal bleeding.
  • Shock: Shock could mean an increased sweaty skin, heartbeat, declining mental functions and low blood pressure. Shock is often a result of blood loss in the circulatory system.
  • Compartment Syndrome: Sometimes, internal bleeding may cause an increase in pressure to the muscles, resulting in what is called compartment syndrome.
  • Pain in the joints: the pressure exerts on blood vessels, often causes joint pain which may cause internal bleeding. Some patients who suffer from joint pain find the ache to be chronic, unmanageable and unbearable. This type of internal bleeding has been linked to patients who use an anticoagulant, for instance Eliquis or, Xarelto as well as Pradaxa.
  • Bleeding in the Head: Symptoms such as vision problems, general body weakness, headaches, confusion, or slurred speech may signify internal bleeding in the head. If you suffer from any of these symptoms frequently, you may want to consult a physician to be tested for internal hemorrhage.

If you are experiencing any of these Pradaxa side effects, you should contact your health care professional or go to an emergency room immediately. Remember not to discontinue any medication on your own without first consulting with a medical care provider to make sure it is safe to do so.

Patients Counseling information about Pradaxa

  • You should not subscribe for Pradaxa if you have an artificial heart valve, or if you have any active bleeding from an injury, surgery or other cause.
  • Because Pradaxa uses keeps your blood from clotting (coagulating) to prevent unwanted blood clots, this medicine can equally make it easier for you to bleed, even from a minor complication for example a fall or a bump on the head. Put away activities that may elevate your risk of injury or bleeding. Call your doctor or seek emergency medical attention if you have bleeding that will not stop.
  • Pradaxa uses can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), particularly if you have a genetic spinal problem, if you have a spinal catheter in place, if you have a history of spinal operation or repeated spinal taps, or if you are also using other medicines that can affect blood clotting. This type of blood clot can result to long-term or permanent paralysis.

Get emergency medical assistance if you have symptoms of a spinal cord blood clot such as back pain, loss of bladder or bowel control or numbness or muscle weakness in your lower body. Do not stop taking Pradaxa without your doctor's advice. Stopping the medication can accelerate your risk of stroke.

 

Warnings and Precautions of Pradaxa

i). Increased risk of thrombotic events after premature discontinuation

​Premature discontinuation of any oral anticoagulant, including Pradaxa, in the absence of sufficient alternative anticoagulation increases the danger of thrombotic events. If Pradaxa uses are discontinued for a reason other than pathological bleeding or completion of a course of treatment, consider coverage with another anticoagulant and restart Pradaxa as soon as medically appropriate.

ii). Risk of bleeding

Pradaxa increases the risk of bleeding and can cause significantly sometimes, terrible bleeding. Promptly identify any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hypotension or hematocrit). Discontinue Pradaxa in patients with active pathological bleeding. Risk factors for bleeding include the concomitant use of other drugs that increase the risk of bleeding (for instance; fibrinolytic treatment, anti-platelet agents and heparin). Pradaxa’s anticoagulant function and half-life are higher in patients with renal impairment. Reversal of Anticoagulant Effect: A specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is required:

  • ​For emergency surgery/urgent modalities
  • ​ uncontrolled bleeding or in life-threatening  

​Hemodialysis can remove dabigatran; however the clinical experience supporting the use of hemodialysis as a treatment for bleeding is reduced. Prothrombin difficult concentration, or recombinant Factor VIIa may be taken into account, but their use has not been evaluated in clinical trials. Vitamin K and Protamine sulfate are not expected to affect the anticoagulant activity of dabigatran. Consider taking of platelet concentrates in cases where thrombocytopenia is present or long-acting anti platelet drugs have been used.

iii). Spinal/epidural anesthesia or puncture

When neuraxial anesthesia (spinal/epidural anesthesia) or spinal rupture is employed, patients treated with anticoagulant agents are at risk of having an epidural or spinal hematoma which can result in long-term or permanent paralysis. To decrease the potential risk of bleeding associated with the concurrent use of dabigatran and epidural or spinal anesthesia/analgesia or spinal rupture, consider the pharmacokinetics archive of dabigatran. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of dabigatran is low; however, the exact timing to attain a sufficiently low anticoagulant effect in each patient is not known.

Should the doctor decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any symptoms of neurological impairment, such as midline sensory and motor deficits, back pain (numbness, weakness or tingling, in lower limbs), bowel and/or bladder rupture. Instruct patients to quickly report if they witness any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected or noticed, initiate urgent diagnosis and therapy alongside consideration for spinal cord decompression, although such treatment may not prevent or reverse neurological squeal/pain.

iv). Thromboembolic and bleeding events in patients with prosthetic heart valves

The efficacy and safety of Pradaxa in patients with leaflet mechanical prosthetic heart valves were evaluated in the RE-ALIGN test, in which patients with leaflet mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose adjusted warfarin or 150, 220, or 300 mg of Pradaxa two times in a day. RE-ALIGN was eliminated early due to the occurrence of significantly more thromboembolic events (stroke, valve thrombosis, myocardial infarction and transient ischemic attack) and an excess of major bleeding (predominantly post-operative pericardial effusions requiring intervention for hemodynamic compromise) in the Pradaxa treatment arm as compared to the warfarin treatment ankle. These thromboembolic and bleeding events were seen both in patients who were initiated on Pradaxa post-operatively within three days of mechanical leaflet valve implantation, and equally in patients whose valves had been implanted more than three months prior to enrollment. Therefore, the uses of Pradaxa are contraindicated in patients with mechanical prosthetic valves. The use of Pradaxa for the prophylaxis of thromboembolic events in patients with atrial fibrillation in the setting of other forms of valvular heart disease, couple with the presence of a bio prosthetic heart valve has not been studied and is not approved.

v). Effect of P-gp inducers and inhibitors on dabigatran exposure

The concomitant uses of Pradaxa with P-gp inducers (for instance, rifampin) decrease exposure to dabigatran and should generally be put off. P-gp inhibition and impaired renal role are the major independent factors that result in increased exposure to dabigatran. Concomitant prescription of P-gp inhibitors in patients with renal impairment is expected to produce an increased exposure of dabigatran compared to that seen with either factor alone. Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation Reduce the dose of Pradaxa to 75 mg twice daily when dronedarone or systemic ketoconazole is co-administered with Pradaxa in patients with moderate renal impairment. Avoid the use of Pradaxa and P-gp inhibitors in patients with severe renal impairment. Reduction and Treatment in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism. Avoid use of Pradaxa and concomitant P-gp inhibitors in patients with moderate renal impairment. ​Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery. Avoid the use of Pradaxa and concomitant P-gp inhibitors in patients with moderate renal impairment.

Uses of Pradaxa

The following uses of Pradaxa could be seen in the following areas below:

i). Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation 

the Pradaxa is used to reduce the danger of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

ii). Treatment of deep venous thrombosis and pulmonary embolism

Pradaxa is used for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days.

iii). Reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism

Pradaxa is used to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

iv). Prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery

Pradaxa is used for the prophylaxis of deep vein thrombosis and pulmonary embolism, in patients who have undergone hip replacement surgery.

 

Dosage of Pradaxa

Take the dosage of Pradaxa exactly as prescribed by your physician. Follow the instructions on your prescription label keenly.

i). Non-valvular atrial fibrillation:

  • For patients with moderate renal impairment: 150 mg in oral order, two times in a day 
  • For patients with severe renal impairment:: 75 mg orally, two times in a day

ii). Treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism):

For patients with moderate renal impairment: 150 mg in an oral pattern, two times in a day after 5-10 days of parenteral anticoagulation.

iii). Reduction in the risk of recurrence of DVT and PE:

For patients with moderate renal impairment: 150 mg in an oral order, two times in a day after previous therapy.

iv). Prophylaxis of DVT and PE Following Hip replacement surgery:

For patients with moderate renal impairment: 110 mg in an oral pattern the first day, then 220 mg once a day.

 

Dosage Forms and Strengths of Pradaxa

75 mg capsules having a cream-colored opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R75”.

110 mg capsules with a faint blue opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a light blue opaque body imprinted in black with “R110”.

150 mg capsules with a faint blue opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R150”.

Overdose of Pradaxa

Accidental overdose may result to hemorrhagic complexities. In the event of hemorrhagic complexities, initiate precise clinical support, discontinue therapy with the dosage of Pradaxa, and investigate the root of bleeding. A concise reversal agent (idarucizumab) is available. Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of exactly 35%. Homodialysis can remove dabigatran; however, data supporting this method are limited. Taking a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, exactly 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, exactly 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable acceleration in clearance noticed at higher blood flow rates. Upon the demise of hemodialysis, a redistribution effect of precisely 7% to 15% is seen. The effect of dialysis on dabigatran's plasma concentration would be expected to vary based on patient specific features. Measurement of a PTT or ECT may assist, guide treatment.

Storage conditions of Pradaxa

 Keep Pradaxa at room temperature between 59 F to 86 F (15 C to 30 C). After opening
the bottle, use Pradaxa within 30 days. Safely throw off any unused Pradaxa after
30 days. Store Pradaxa in the original container to present it dry. Keep the bottle firmly closed. Keep Pradaxa and all drugs out of the reach of children.

Use in specific populations

i). Pregnancy Category C

There are no adequate and well-managed studies in pregnant women. Dabigatran has been known to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human disclosure at maximum approved human dose (MRHD) of 300 mg/day based on area under the curve (AUC) comparisons) prior to mating and up to implantation (gestation Day 6). Therapy of pregnant rats after implantation with dabigatran at the same dose increased the number of dead children and caused excess vaginal/uterine bleeding close to parturition. 

ii). Labor and delivery

Effectiveness and safety and of Pradaxa during labor and delivery have not been studied in clinical tests. Consider the dangers of bleeding and of stroke in using Pradaxa in this setting. Death of children and mother rats during labor in association with uterine bleeding happened during treatment of pregnant rats from implantation (gestation Day 7) to weaning (lactation Day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human disclosure at MRHD of 300 mg/day based on AUC comparisons).

iii). Nursing mothers

It is unknown whether dabigatran is excreted in the human milk. Due to the fact that several drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Pradaxa, a decision should be taken whether to discontinue nursing or to discontinue the drug, taking into consideration the significance of the drug to the mother.

iv). Pediatric use

Effectiveness and safety and of Pradaxa in pediatric patients have not been developed.

v). Geriatric use

Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The danger of stroke and bleeding augments with age, but the risk-benefit profile is suitable in all age groups.

vi). Renal Impairment

Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation

No dose adjustment of Pradaxa is recommended in patients with moderate renal impairment. Reduce the dosage of Pradaxa in patients with severe renal impairment. A dose advisable for patients with severe renal impairment or on dialysis cannot be provided. Adjust dose appropriately in patients with renal impairment receiving concomitant P-gp inhibitors.

Reduction and treatment on the risk of recurrence of deep venous thrombosis and pulmonary embolism

Patients with severe renal (kidney) impairment were excluded from re-cover. Dosing recommendations for patients with severe kidney impairment or on dialysis cannot be made available. Strike off the use of Pradaxa with concomitant P-gp inhibitors in patients with severe renal impairment.

A disclaimer: The objective of this article is to give you relevant information pertaining to the drug Pradaxa. For this reason, therefore, the information exposed in this article should in no occasion be elevated above the prescription of your physician.

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