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IC 93 articles

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. Blood tends to pool in the atrial chamber of individuals with atrial fibrillation, which can lead to clotting and an increased risk for strokes. Patients with atrial fibrillation are generally treated with blood thinners to help prevent blood clots from forming. However, blood ... Read More

FDA announces labeling changes for heparin

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. The label changes include modifications to the Warnings, Precautions and Adverse Reactions sections of Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in 0.9 % Sodium Chloride Injection. The labeling changes in part were spurred by the much-publicized overdosing of actor Dennis Quaid’s newborn twins, who nearly died in 2007 when ... Read More

Hamburg, Sharfstein to head troubled FDA

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. Sharfstein made headlines in 2007 when he convinced the FDA to restrict the use of over-the-counter children’s cough and cold medicines based on evidence they can cause serious health complications and even death in children. If ... Read More

Lawmakers debate safety of importing drugs

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. Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured. After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood ... Read More

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 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. Heparin is routinely given to patients before certain types of surgery and prior to treatments such as kidney dialysis to prevent blood clots from forming. Clots that do not naturally dissolve ... Read More

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 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. Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in ... Read More

New budget supports plan for importation of drugs

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.” However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health ... Read More

FDA knew of tainted syringes two years before inspecting plant

The FDA received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press. AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted. Earlier this week, workers ... Read More

Two sentenced for role in tainted heparin, saline syringes

In an effort to ship heparin– and saline-filled syringes faster, workers at a facility in North Carolina failed to check sterility and then falsified manufacturing dates to make it appear those safeguards were followed, according to an Associated Press report. Those syringes, as it turned out, were tainted with a bacteria known as Serratia marcescens and may have lead to five deaths and hundreds of infections in those who received them. Earlier this week two former workers at the plant, plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma, were sentenced in federal court to more than four ... Read More

Baxter named in contaminated saline syringe lawsuit

Pharmaceutical giant Baxter International faces yet another lawsuit, this time for playing a role in the distribution of a contaminated saline syringe that was used on a woman who afterward suffered serious medical problems that may have led to her death a year later, according to the Hays Daily News. Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later ... Read More