News Tagged ‘side effects

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 (). The 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’ Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration () to manufacture and market is generic Lovenox, 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. Lovenox has been touted as an effective replacement for the heparin in patients undergoing abdominal surgery.

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FDA panel recommends agency approval of heparin alternative

blood cells 100x100A Food and Drug Administration () 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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Class action lawsuit filed against Baxter over tainted heparin scandal

A class action lawsuit has been filed against Baxter claiming the drug maker substituted an ingredient in its heparin with a cheaper, more dangerous one in order to reap more profits, according to the Madison-St. Clair The Record. Twenty-eight people are named in the lawsuit, most of whom are spouses of individuals who died after receiving injections of the tainted heparin. The lawsuit was filed in St. Clair County Court in Illinois.

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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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Study compares brands of heparin given to ICU patients

An intensive care doctor at St. Joseph’s Healthcare in Hamilton, Ontario, is questioning hospitals’ choice of using a newer heparin drug over another, raising concern that the choice is made not based on the quality of the drug but rather better marketing, according to The Hamilton Spectator.

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Scientists develop heparin antagonist medication

Scientists in Poland are developing a new way to remove heparin from blood in order to reduce or avoid the occurrence of unwanted side effects, according to Science Centric.

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doctors favor drug safety litigation

Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

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