The blood thinners included in this announcement include Arixtra (fondaparinux sodium) Solution for subcutaneous injection; Fragmin (dalteparin sodium injection) for Subcutaneous Use; Innohep (tinzaparin sodium) injection; and Lovenox (enoxaparin sodium) injection for subcutaneous and intravenous use.

The new warning states that epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals are asked to consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

• Use of indwelling epidural catheters
• Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
• A history of traumatic or repeated epidural or spinal punctures
• A history of spinal deformity or spinal surgery

Health care providers are encouraged to monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Benefits and risks should be weighed before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

SOURCE: Heparin Recall › Revised boxed warning placed on blood thinners

Thrombophilia refers to a number of genetic conditions that increase the tendency of the blood to clot, which can lead to serious and/or life-threatening complications depending on the location of the clot. It is a major factor associated with recurrent IVF-ET, as it can cause complications in pregnancy such as stillbirth, preeclampsia and declampsia.

The study included 83 women with a history of three or more previous IVF failures who had at least one thrombophilic defect. One group received 40 mg of enoxaparin per day, the other received a placebo. Both treatments were started on the day of embryo transfer (ET) and continued until delivery or until feotal demise.

According to the study, patients who received the low-molecular weight heparin had a significant increase in the implantation and pregnancy rates compared to those who took the placebo: Those on enoxaparin had a 20.9 percent implantation rate and a 31 percent pregnancy rate as opposed to the placebo group which had a 6.1 implantation rate and a 9.6 pregnancy rate. There also was a significant increase in the live birth rate – 23.8 percent in the group taking enoxaparin to 2.8 percent in the placebo group.

SOURCE: Heparin Recall › Low molecular weight heparin drug found effective in IVF-ET

Thromboembolism is a blood clot in the blood vessel that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs, causing pulmonary embolism; brain, causing a stroke; gastrointestinal track, kidneys or leg. Thromboembolism is a common complication of cancer and cancer treatments, and is usually treated with blood thinners, such as heparin.

Though a relatively new therapy for the prevention of thromboembolism, low-molecular-weight heparins, such as nadroparin, are as effective as high-molecular-weight heparins. One benefit to low-molecular-weight heparins is that treatment can be started and completed in an outpatient setting, as opposed to high-molecular-weight treatments, which require in-hospital monitoring.

The study involved 1,166 patients with metastatic cancer receiving chemotherapy for cancers involving the lungs, breasts, head and neck, stomach, colon, rectum and pancreas. The incidence of blood clots in patients who received nadroparin was 2.1 percent compared to 3.9 in patients who received a placebo. Higher rates of thrombembolism was present in patients with lung and pancreatic caners. The study also showed a slight (0.7 percent) incidence of major bleeding in patients who received nadroparin compared to 0 percent in the placebo group.

SOURCE: Heparin Recall › Low-molecular-weight heparin good therapy for cancer patients