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Baxter 46 articles

Nitroglycerin infusion recalled due to possible contamination

One lot of nitrogylcerin infusions used to treat heart patients is being recalled by the manufacturer because of possible contamination that could cause a blockage of blood vessels and other potentially serious health consequences. The recall involves nitroglycerin in 5% dextrose injection made by Baxter. The affected lot may contain particulate matter that if injected has the potential to cause venous and/or arterial thromboembolism, or a blockage of blood vessels. Other potential adverse events that can arise from the contaminated vials include inflammation, particularly in the lungs, and local irritation of blood vessels. Nitroglycerin in 5% dextrose injection is an ... Read More

FDA warns medical staff of malfunctions with syringes

The Food and Drug Administration is warning emergency medical personnel not to use needleless pre-filled glass syringes with the cardiac drugs adenosine and amiodarone in vials in emergency situations. The syringes may malfunction, break or become clogged during the process of attempting to connect the needleless IV access systems. This can cause a delay in treatment, which can result in serious harm to patients. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a cardiac drug that is administered ... Read More

FDA clears Baxter in deaths following heparin injections

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. Announcement of the deaths and illness at Beebe Medical Center in Lewes, Delaware, raised immediate concern at the hospital, which promptly notified the FDA and Baxter. The incidents were far too similar to the 2007 heparin scandal in which more ... Read More

Baxter says it's not responsible for recent heparin deaths, illness

It’s like a bad dream happening all over again – people falling ill or dying after receiving doses of the blood thinner heparin. In 2007, tainted doses of heparin killed more than 80 Americans and injured hundreds more. And while investigations into the cause continue, the culprit was found to have been over-sulfated chondroitin sulfate (OSCS) a heparin-mimicking contaminant that made its way into batches of heparin that were manufactured in Baxter International’s China plant. Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. ... Read More

New deaths, illness following heparin use spark FDA investigation

The Food and Drug Administration (FDA) is testing batches of the blood thinner heparin after two people died and one became ill after receiving doses of the heparin, according to the Wall Street Journal. All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio. The heparin in question involves premixed intravenous bags of ... 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

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

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

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

Scientists propose new testing standards for heparin

Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-mimicking contaminant that can cause serious allergic reactions in humans. The new standards were proposed ... Read More