The label changes include modifications to the Warnings, Precautions and Adverse Reactions sections of Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in 0.9 % Sodium Chloride Injection.

The labeling changes in part were spurred by the much-publicized overdosing of actor Dennis Quaid’s newborn twins, who nearly died in 2007 when they were accidentally given 1,000 times the intended dose of the blood thinner. The Quaid’s case is just one of many cases where health care workers claimed to have confused high-dose and low-dose heparin. Some argue that the two bottles can be easily confused.

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatening bleeding or hemorrhages, including in the brain.

Heparin has seen its fair share of the spotlight lately. Last year more than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with oversulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death.

SOURCE: Heparin Recall › FDA announces labeling changes for heparin

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular blood thinner, warfarin. Heparin is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to heparin and warfarin, especially since the tainted heparin scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of heparin that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions in humans.

The FDA is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral blood thinner approved since the FDA approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the FDA as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCE: Heparin Recall › FDA panel recommends agency approval of heparin alternative

In early December, the FDA announced that it had received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased mortality in elderly patients.

As a result, in July, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age and older. However, preliminary data from IRIS suggests that the increased risk of mortality is not only limited to patients in that age range. Study results suggest that compared to unfractionated heparin, Innohep increases the risk of death for patients 70 years and older with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The FDA suggested health care professionals consider the use of alternative treatments for patients older than 70 years of age with those conditions.

The FDA says it anticipates submission of the final IRIS study report sometime in January and will complete its review soon thereafter. Additional regulatory actions as appropriate will be considered after thorough review of all applicable data from the manufacturer of Innohep.

SOURCE: Heparin Recall › Celgene issues letter warning of limited use of heparin drug

Blood thinners are routinely given to patients before certain types of surgery and treatments such as kidney dialysis to prevent blood clots from forming. Clots that do not naturally dissolve can travel through the blood stream and end up in the brain, causing a stroke, or in the lungs, causing a pulmonary embolism. Blood clots, also known as thrombosis, is a serious problem affecting nearly a million Americans each year and killing nearly 300,000 annually.

Two more common types of blood thinners are heparin and warfarin. Heparin is administered intravenously, requiring medical supervision, whereas warfarin is given orally. Both drugs have been used medically for decades. Both have side effects that doctors and patients find bothersome, including easy bruising, excessive bleeding, lower back pain, weakness or light-headedness, and flu-like symptoms. Thus physicians are eager to find safer alternatives.

Furthermore, heparin has been in the spotlight continuously over the past several months for confusing labeling that has resulted from overdoses that have sickened and killed patients, as well as batches of contaminated heparin that made its way into hospitals, causing more illnesses and deaths in patients who received the bad lots.

SOURCE: Heparin Recall › Drug makers rush to produce new blood thinners

At the time the study was stopped, 350 patients had completed a 90 days of follow-up. Twenty-three out of 176 patients who received tinzaparin died, compared to nine out of 174 who received unfractionated heparin. The FDA says it sees no clear pattern as to the cause of death nor do the deaths appear to be related to either over-dosing or under-dosing of an anti-coagulant.

In July, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age and older. However, preliminary data from IRIS suggests that the increased risk of mortality is not only limited to patients in that age range. Study results suggest that compared to unfractionated heparin, Innohep increases the risk of death for patients 70 years and older with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The FDA suggests health care professionals consider the use of alternative treatments for patients older than 70 years of age with those conditions.

The FDA has requested that the labeling for Innohep be revised to better describe the overall results of IRIS. The agency anticipates final IRIS results in January 2009, and will complete its review at that time.

SOURCE: Heparin Recall › FDA requests better labeling of low molecular weight heparin

Heparin is a blood thinner that is routinely used before certain types of surgery or other procedures to prevent clotting. It also is widely used for patients with chronic thrombotic conditions. Heparin is administered intravenously, which requires constant monitoring of doses and in-patient hospital stays. An oral alternative could reduce the need for expensive hospital stays.

About 2 million Americans each year suffer from thrombotic conditions and another 200,000 die each year from stroke, myocardial infarctions or pulmonary emboli as a result of thrombosis, according to the report.

The heparin will use glycosaminoglycan (GAG) technology to develop the oral alternative.

“The introduction of an oral heparin into clinical medicine would be a significant development and would have commercial, therapeutic and economic potential. We are pleased that Glycotek will take on this important challenge while at HCAR,” said Laura Butcher, Executive Director of HCAR, in the Business Wire report.

Glycotek will pursue both business and research and development activities at HCAR. Building upon its activities already in practice at its New York location. HCAR provides state-of-the-art facilities and high-value business and research resources.

SOURCE: Heparin Recall › Glycotek developing oral alternative to heparin

The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing facility.

While heparin is considered an effective treatment for preventing blood clots and is widely used, it must be injected, which makes long-term therapy difficult. The new drugs would be taken by mouth, which would make dosing easier and eliminate the need for laboratory monitoring.

Heparins garner about $700 million in annual sales, with Sanofi-Aventis’ Lovenox making up nearly two-thirds of the world’s share of the drug. Pfizer’s Fragmin and GlaxoSmithKline’s Fraxiparine account for 6.3 and 5.9 of sales, respectively. Vitamin K Antagonists are responsible for more than $6 billion in sales worldwide, with Bristol-Myers Squibb’s Coumadin, Barr’s Warfarin and Eisai’s Warfarin owning slightly more than half the market’s share.

Three of the five companies are in the late phases of clinical testing, two of which already have been approved in Canada and are awaiting approval in the United States. Two other companies’ drugs have been approved for short-term use in Europe.

SOURCE: Heparin Recall › Pharmaceutical companies developing drugs to fight blood clots