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As many as 300 product-liability lawsuits may be filed in the Illinois state court against drug maker Baxter International Inc., by people injured by or families who lost loved ones to contaminated batches of the blood thinner heparin. Per a judge’s order last year, attorneys are working to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based drug company.
A 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.
The blood thinner heparin will now include a new reference standard and test method that is used to determine the potency of the drug and detect impurities that may be present in it, according to a safety alert issued by the Food and Drug Administration (FDA). The change is effective as of October 1, 2009, and will harmonize the USP unit dose with the WHO International Standard unit does, which will result in an approximately 10 percent reduction in the potency of the heparin marketed in the United States.
A recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin.
Four lawsuits were filed last month in Cook County, Illinois court against the makers of the blood thinner heparin, claiming the product the company manufactured was contaminated and caused patients to die.
The Food and Drug Administration (FDA) has granted pediatric exclusivity to The Medicines Company for its anticoagulant Angiomax. The approval is based on studies submitted in response to a Written Request by the FDA to investigate the use of Angiomax in pediatric patients aged birth to 16 years.
“The FDA’s decision responds to the critical need for effective anticoagulant treatments for children undergoing intravascular heart procedures,” said Rolando Zamora, MD, Director of Pediatric Interventional Cardiology, Methodist Children’s Heart Institute, San Antonio, TX.
“There have been very few studies of anticoagulation in children, especially in those undergoing these critical heart procedures, and current agents have major disadvantages in the pediatric population. Angiomax could have an important impact on this young patient population,” said Ziyad Hijazi, MD, Director of the Center for Congenital and Structural Heart Disease, Professor of Pediatrics and Internal Medicine, Rush University Medical Center, Ill.
In clinical trials, treatments with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus GPI across the spectrum of risk in patients undergoing angioplasty, and lower rates of 1-year mortality in patients undergoing angioplasty.
In the U.S., Angiomax with provisional GPI is indicated in patients undergoing angioplasty or at risk of heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing angioplasty.
Source: PR Canada.net
Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died.
A Chinese senior health official says China has been unfairly labeled as a center for fake drug production and that blame should be placed instead on foreign companies who do business with unregistered firms against Chinese regulations.
Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers.
Surgeons are anticipating the approval of new blood thinners that could replace more conventional methods currently in use, according to the Ortho SuperSite, a resource for orthopedic surgeons and rheumatologists.
Baxter Healthcare Corp. has been cleared by the Food and Drug Administration (FDA) in the deaths of two patients at a Delaware hospital following an injection of the drug maker’s blood thinner heparin. The FDA attributed the two deaths, and the illness of a third patent, to existing medical conditions. All three patients suffered intercranial bleeding following injections of heparin.
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