Orgaran Side Effects

Generic name: danaparoid

Note: This document contains side effect information about danaparoid. Some of the dosage forms listed on this page may not apply to the brand name Orgaran.

Some side effects of Orgaran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to danaparoid: subcutaneous solution

If you experience any of the following serious side effects, stop using danaparoid (the active ingredient contained in Orgaran) and seek emergency medical attention or call your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• any prolonged or unexplained bleeding;

• pain, warmth, or redness in an arm or leg, or difficulty breathing, which could indicate a blood clot; or

• ulceration at the injection site.

Other less serious side effects may be more likely to occur. Continue to use danaparoid and notify your doctor if you experience

• mild pain, redness, or warmth at the injection site;

• rash or itching;

• fever;

• difficulty urinating;

• dizziness;

• nausea or vomiting;

• constipation;

• swelling or water retention;

• insomnia; or

• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to danaparoid: subcutaneous solution

Hematologic

A fatal bleeding episode has been reported in a patient with renal insufficiency. Overall, probable or possible danaparoid-associated mortality due to bleeding, thrombosis, or septic shock occurred in 7 of 230 patients (3.0%).

Danaparoid has shown a much lower in vitro cross-reactivity with heparin-induced antibody than some low molecular weight heparins (6.3% versus 95%, respectively). In fresh patient plasma, 14 of 143 (9.8%) of danaparoid (the active ingredient contained in Orgaran) tests showed positive cross-reactivity with heparin-induced antibody.

Patients previously exposed to unfractionated heparin or a low-molecular-weight heparin appear to be more susceptible to developing heparin-induced thrombocytopenia (HIT) and HIT-related thromboembolic complications (e.g., transient ischemic attack, stroke) than those who were never exposed.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated, prothrombotic reaction that occurs in 0.5% to 5% of patients treated with unfractionated heparin and in less than 1% of patients treated with a low molecular weight heparin (LMWH). The decrease in platelet count associated with HIT usually begins 5 to 14 days after starting heparin. However, patients with a previous exposure to heparin may have an abrupt decrease in platelets upon restarting heparin. Patients with LMWH-induced HIT exhibit a longer delay in the onset of symptoms compared with those who develop it from unfractionated heparin. Following discontinuation, platelet counts begin to recover within 4 days, but may take more than 2 weeks in patients with high-titer HIT antibodies. Thrombocytopenia is caused by heparin-dependent IgG antibodies that bind to a specific platelet protein, platelet factor 4 (PF4). The heparin-PF4-IgG immune complex binds to platelets causing platelet activation. The activated platelets cause release of platelet-derived procoagulant microparticles, which accelerate coagulation reactions and generates thrombin. LMWHs have a high cross-reactivity with circulating heparin-PF4-IgG immune complex. Factors associated with a higher risk for developing HIT-associated thrombosis include women, nonwhites, severity of thrombocytopenia, and lower body weight. Complications associated with HIT include exacerbation of venous thromboembolism, arterial or venous thrombosis, limb gangrene, stroke, and skin necrosis. The antibodies that cause HIT will usually disappear after approximately 3 months; therefore, use of unfractionated heparin or LMWH may be considered in a patient with a history of HIT if the antibody test is negative.

Patients undergoing spinal/epidural anesthesia or puncture and anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk for long-term or permanent paralysis due to epidural or spinal hematoma. The risk of these events is increased by the use of indwelling epidural catheters or by concomitant use of platelet inhibitors, other anticoagulants, or drugs that affect hemostasis.

Hematologic adverse effects that have been reported include hemorrhage (intraoperative and postoperative blood loss), bruising and wound hematoma. Incidence of bleeding complications appear to be similar to heparin (approximately 10%). Thrombocytopenia has been reported to occur significantly less than with heparin or low molecular weight heparins. Danaparoid is considered a useful substitute for heparin or low molecular weight heparins in thrombocytopenia for the majority of patients who require immediate anticoagulation, although thrombocytopenia has been reported in patients receiving danaparoid.

Local

Local effects may include injection site discomfort and bruising. The incidence of bruising appears to be less with heparin.

Hypersensitivity

Hypersensitivity reactions have included a Type IV (IgE) delayed hypersensitivity cutaneous reaction due to subcutaneous injection danaparoid (the active ingredient contained in Orgaran) The reaction was described as a red, itchy, indurated and erythematous.

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