News Tagged ‘blood clots

Revised boxed warning placed on blood thinners

lovenox 100x100A group of blood thinners used to reduce the risk of deep vein blood clots in patients has updated their products’ safety labeling and revised the boxed warning to include a risk of epidural or spinal hemotomas in some patients, according to an announcement by the Food and Drug Administration (FDA). The FDA places boxed warnings, also known as black box warnings, on drugs that, based on medical studies, carry a significant risk of serious adverse side effects or death.

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FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration (FDA) to manufacture and market is generic , M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call.

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. has been touted as an effective replacement for the heparin in patients undergoing abdominal surgery.

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Heart device may eliminate need for heparin, warfarin

A small device implanted in the heart to stop blood clots from triggering strokes could serve as an alternative to blood thinners such as heparin and warfarin, according to a new study conducted by the device’s maker, Atritech, Inc. The device, called the Watchman, is designed specifically for patients with atrial fibrillation, a type of irregular heartbeat.

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FDA panel recommends agency approval of heparin alternative

A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.

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Researcher awarded NIH grant for development of synthetic heparin

A researcher at the University of North Carolina at Chapel Hill received a $1.48 million grant from the National Institutes of Health to support research into Recomparin, a synthetic version of the heparin, according to the Triangle Business Journal. Associate Professor of Pharmacy Jian Liu invented the synthetic anticoagulant and hopes the grant money will help him perfect the drug and find better ways of synthesizing it.

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Czech ‘heparin murderer’ gets life in prison

Petr Zelenka liked the excitement around crisis situations and the constant activity of hospital staff, which is why he pursued a position at an anaesthesiological-resuscitation ward at Havlickuv Brod hospital in the Czech Republic. To further his excitement, he administered heparin to patients between May and September 2006, which resulted in serious health complications and even death in some patients.

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Celgene issues letter warning of limited use of heparin drug

Just weeks after the FDA requested revised labeling for the low molecular weight heparin, Innohep, the FDA announced that its maker Celgene Corporation has issued a “Dear Healthcare Professional” letter describing a controlled clinical study that suggests an increased risk of death in elderly patients who received Innohep. Innohep contains tinzaparin sodium that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

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Head injury protocol reduces death rate for patients on blood thinners

Blood thinners, like heparin, are routinely administered or prescribed to patients to help prevent blot clots that can lead to heart attacks or strokes. But if a patient taking blood thinners bumps his head, he is at greater risk for undetected brain bleeds and death, according to Emax Health.

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Older Americans may be taking hazardous drug combinations

More than 50 million older Americans – or 91 percent of that population – take at least one medication, and at least 2 million of them are combining their medication with other drugs or supplements that may be hazardous to their health, according to the Associated Press.

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Drug makers rush to produce new blood thinners

New blood-thinning medicines are in the works and to offer doctors more options in treatment and prevention of blood clots, according to Bloomberg. Bloomberg reports that at least six companies are working on blood thinners to take advantage of a growing need. According to Datamonitor, a London-based research company, the anticoagulation drug market is expected to reach $20 million by 2012.

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