› $4.85 Billion settlement in drug case
Rep. Joe Barton of Texas wants the Food and Drug Administration (FDA) to turn over databases stemming from last year’s tainted heparin scandal that killed more than 80 Americans and injured hundreds more, according to NASDAQ.com. At a public hearing last week, Barton raised concerns that the agency doesn’t know for sure what caused the contamination.
The Food and Drug Administrating (FDA) is accusing two Chinese pharmaceutical manufacturing companies of lying to federal regulators about their role in shipping batches of contaminated heparin into the United States between 2007 and 2008, according to Easy Bourse.
Dusty Martin blamed himself after almost losing his 8-year-old son Michael to a bacterial infection. The boy is a hemophiliac who needs regular injections of medicine to reduce the risk of bleeding to death from a slight cut. Martin uses pre-filled syringes of saline and heparin to flush out the port in his son’s chest before administering his medication. But early last year, shortly after receiving his drugs, Michael began shaking. His temperature shot up to 106 and Martin rushed him to the hospital where he underwent emergency surgery.
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.
The Food and Drug Administration (FDA) announced this week safety labeling changes on the blood thinner heparin to include warnings of fatal medication errors that have resulted in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), in particular in neonates, or infants less than a year old.
A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental blood thinner 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.
The Obama administration has named two doctors to head up the much-criticized U.S. Food and Drug Administration (FDA), individuals who are known for speaking out about public safety. Sources say Margaret Hamburg, a physician and former New York City health commissioner, was selected to run the agency with Joshua Sharfstein, of the Baltimore health commission, as her chief deputy, according to The Washington Post.
Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio.
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 blood thinner 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.
A class action lawsuit has been filed against Baxter claiming the drug maker substituted an ingredient in its blood thinner 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.
