Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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

Watchdog group Project on Government Oversight (POGO) is asking the Food and Drug Administration (FDA) inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products.

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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.

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