“As orthopedic surgeons, we look very critically at safety; we look very critically at efficacy. I think it is fair to say, if we consider those to be equal and the dosing schedule is equal, (and) they are both once-a-day, then it comes down to cost,” Richard J. Friedman, M.D., was quoted in the publication. “But we are looking (at) safety first and efficacy afterward.”

The topic, spurred by positive Food and Drug Administration (FDA) advisory committee reviews of rivaroxaban, was discussed recently at the 76th annual meeting of the American Academy of Orthopaedic Surgeons. Rivaroxaban, made by Bayer and marketed in other countries as Xarelto, is just one of many anticoagulants in development and expected to be on the market in the next one to three years.

Heparin is an injectible used in hospitals because it is easier to control than Coumadin, also known as warfarin, which requires close monitoring and frequent blood tests. Rivaroxaban is an attractive alternative because it comes in a pill and doesn’t require constant monitoring. If approved by the FDA, Rivaroxaban will be marketed by Ortho-McNeil Pharmaceuticals.

“Often in orthopedics, even the best of folks take a long time to incorporate and change practice patterns,” said Fred D. Cushner, M.D. “The big question is, who is going to switch? … This is debatable, but my personal opinion is the injectables will probably be the first to go.”

SOURCE: Heparin Recall › Surgeons hopeful about new alternatives to heparin

Blood tends to pool in the atrial chamber of individuals with atrial fibrillation, which can lead to clotting and an increased risk for strokes. Patients with atrial fibrillation are generally treated with blood thinners to help prevent blood clots from forming.

However, blood thinners like heparin can cause serious bleeding episodes and allergic reactions. Alternatives to long-term use of blood thinners has many cardiologists taking notice.

“The findings from this clinical trial are very impressive,” said Dr. Gregg C. Fonarow, professor of cardiology at the University of California, Los Angeles. “Treatment with this novel device will be very attractive and provide patients with atrial fibrillation effective, long-term protection from stroke and systemic embolization without the bleeding risks associated with (blood thinners).”

The PROTECT-AF Trial, which involved 707 patients with a type of atrial fibrillation, showed that patients who had the device had a 32 percent lower risk of stroke and cardiovascular death compared with those on blood thinners. The study also found fewer complications with the implanted device compared to the use of blood thinners.

A Food and Drug Administration (FDA) advisory panel will meet in April to consider the sale of the device in the United States.

Source:
Eflux Media News

SOURCE: Heparin Recall › Heart device may eliminate need for heparin, warfarin

Researchers at Beaumont Hospital in Royal Oak, Michigan, have developed a treatment protocol to quickly and effectively diagnose brain bleeds in patients who are on blood thinners and bump their heads. The study treated 105 patients under the new protocol. As a result, diagnosis of brain bleeds occurred in half the time and treatments were started faster. Under this new system, death rate also was reduced from 40 percent to 11 percent.

The protocol includes rapid initial evaluation by a doctor or nurse, a CT scan performed on a priority basis, a blood transfusion and administration of vitamin K to help the blood clot, according to the report.

“These seem like relatively simple steps, but when combined they become a powerful force that helps save lives,” Emax Health quoted Greg Howells, M.D., director of Trauma Surgery. When the head bumps occur, many people can appear fine even if the injury is causing the brain to bleed. Previous studies have shown that people on blood thinners are four times more likely to die from a blow to the head than those not on blood thinners.

As a result of the study, more than 40 other hospitals across the country have asked about Beaumont’s treatment protocol for people on blood thinners who bump their heads.

SOURCE: Heparin Recall › Head injury protocol reduces death rate for patients on blood thinners

The findings come from research published this week in the Journal of the American Medical Association and funded by the National Institutes of Health and University of Chicago. The study is based on interviews of 3,000 people aged 57 to 85. The research shows that more than half of the older population is taking at least five different medications including prescriptions and over-the-counter drugs or supplements. Men are particularly at risk, according to the report. As many as one in 10 older men were taking drug combinations that could be harmful.

One alarming drug combination occurs when a patient is on a blood thinner. Combined with common over-the-counter medicines such as NSAIDS like ibuprofen, naproxen or aspirin, this can lead to excessive and uncontrolled bleeding. Cigarette smoking also decreases blood levels.

Heparin, one of the more common blood thinners administered intravenously at hospitals before some surgeries and treatments such as kidney dialysis to prevent blood clots, carries the same warnings. Patients – whether at home or in the hospital – should be forthcoming about all medications – prescription and over-the-counter – and supplements they are taking to avoid any potential risk.

Patients also should not take new over-the-counter medication or supplements or stop taking a medication without first checking with their doctors.

SOURCE: Heparin Recall › Older Americans may be taking hazardous drug combinations

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

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

The new expanded recall includes all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. The recall will not include Baxter’s heparin pre-mix IV solutions in bags.

Although there was a danger of contamination that could result in adverse patient reaction, the U.S. Food & Drug Administration did not require Baxter to do a full recall of the product in January because pulling all of the product could create a shortage for operating rooms, dialysis centers and other critical areas that use the product, which is a blood thinner.

According to a Baxter news release, in January the FDA determined the risk of patients not receiving any heparin blood thinners when it was critically needed was greater than that of patients receiving contaminated product. Baxter is one of the leading suppliers of heparin products, manufacturing about one half of the multidose vials used each month by health care providers.

The FDA now feels there is enough heparin available from other sources to allow Baxter to pull its remaining, possibly contaminated, product.

Customers are advised to immediately discontinue use of recalled product, and to contact Baxter for return and replacement.

Despite FDA assurances that there is enough heparin product in the market to treat critical patient needs, by March health care providers were being more careful with prescribing their existing supplies as a result of the more limited supply.

SOURCE: Heparin Recall › Baxter expands heparin recall