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deadly 116 articles

FDA allows clinical trials on brain drug for patients with severe TBI to resume

The U.S. Food and Drug Administration (FDA) is allowing Oxygen Biotherapeutics Inc. to resume patient testing on its experimental brain injury drug Oxycyte, nearly six years after the agency suspended clinical trials of the drug due to concerns about its use in patients with severe traumatic brain injuries (TBI). TBIs are caused by a blow to the head or a penetrating head injury and interfere with normal brain functioning. About 52,000 people die from TBI in the United States each year, according to the Brain Trauma Foundation. When someone suffers from a TBI his platelet count significantly drops in response ... Read More

$100 million settlement for fungal meningitis victims expected soon

Victims of the deadly fungal meningitis outbreak linked to contaminated steroid shots could receive a share of a $100 million multidistrict litigation settlement if trustees with the now-bankrupt New England Compounding Center (NECC) and other parties complete a proposed deal. A bankruptcy attorney for the compounding pharmacy responsible for manufacturing and distributing the tainted steroid shots said he has been working with a committee representing victims of the outbreak since the settlements-in-principle were announced in December. He told a Massachusetts federal judge that a completed deal was expected soon. The agreement calls for a victims fund that would first have ... Read More

Study: Acute pancreatitis greatly increases risk of pancreatic cancer

People diagnosed with acute pancreatitis are more likely to develop pancreatic cancer, according to a new study published in the journal Clinical Gastroenterology and Hepatology. Previous studies have shown a higher incidence of pancreatic cancer in patients diagnosed with acute pancreatitis, however it was unknown the rate that acute pancreatitis precedes a diagnosis of pancreatic cancer and the time between the two diagnoses. “Our study demonstrates that there is a much higher risk of pancreatic cancer in patients with acute pancreatitis than commonly believed,” said principle investigator Banke Agarwal, MD, associate professor of gastroenterology and hepatology at St. Louis University. Researchers ... Read More

$100 million offered to plaintiffs in NuvaRing blood clot lawsuits

Merck & Co. has agreed to pay $100 million to settle thousands lawsuits alleging the company’s contraceptive device NuvaRing caused life-threatening blood clots. The only caveat is that at least 95 percent of the eligible complainants must opt into the agreement otherwise no payouts will be made, a federal judge ruled. The deadline is March 10. U.S. District Judge Rodney Sippel called the settlement “a fair resolution of this litigation.” There are about 3,800 eligible participants in the settlement agreement, which includes more than 1,850 state and federal lawsuits as well as claims that have yet to be filed. NuvaRing is ... Read More

Two more GranuFlo lawsuits filed against dialysis giant Fresenius

Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks. Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies. GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands. In March 2012, the ... Read More

Injectable solutions recalled due to particle contamination

Injectable solutions used to hydrate or add electrolytes to some patients are being recalled because there are particles floating in the products that if injected into patients could cause serious and even deadly health consequences. The recall involves one lot of 5% dextrose injection and four lots of 0.9% sodium chloride injection, both manufactured by Baxter International. If injected, a product containing particulate matter may block blood vessels which could cause strokes, heart attacks or organ damage such as to the kidneys or liver. There is also the possibility of allergic reactions, local irritations, and inflammation in tissues and organs. Dextrose injections ... Read More

NECC agrees to pay more than $100 million to compensate victims of fungal meningitis outbreak

The owners and insurers of the Massachusetts compounding pharmacy blamed for a deadly, multistate fungal meningitis outbreak have agreed to pay more than $100 million to settle lawsuits and compensate victims, families of victims and creditors. At least 751 people were sickened and 64 died after receiving contaminated steroid injections manufactured by New England Compounding Center (NECC). About 18,000 tainted shots were distributed to medical facilities in 23 states, and an estimated 14,000 people were exposed to the fungus after receiving the shots commonly used to treat back, neck and joint pain. Hundreds of patients developed fungal infections, including meningitis. ... Read More

Class action lawsuit filed against maker of leukemia drug

A class action lawsuit has been filed against ARIAD Pharmaceuticals, Inc., and some of its officers alleging the company did not adequately list potentially deadly side effects on the label of its leukemia drug Iclusig (ponatinib). In December 2011, ARIAD announced preliminary clinical data that showed “strong clinical evidence of the anti-leukemic activity of ponatinib.” The company went on to tout the “favorable safety and tolerability profile of ponatinib.” The drug won approval for marketing in the United States by the Food and Drug Administration (FDA) based on that data the following year. However, on Oct. 9, 2013, ARIAD updated ... Read More

Combination birth control pills discouraged for older women who smoke

A new black box warning will be added to the safety labels of several brands of estrogen-plus-progestin birth control pills urging women who are older than 35 years of age who smoke not to use the medication because it greatly increases their chances of having a heart attack or stroke. Black box warnings, or boxed warnings, are the strongest warning the Food and Drug Administration (FDA) requires, and signifies that medical studies indicate that using a drug carries a significant risk of serious or even deadly adverse effects. The warnings will be placed on the following oral contraceptives: Modicon (norethindrone/ethinyl ... Read More

Edwards Lifesciences recalls catheter used in heart bypass surgery

Edwards Lifesciences is recalling its EMBOL-X Glide Protection System due to a defect in the catheter tip that if used may cause serious or deadly complications. The EMBOL-X Glide is a device used to help capture material such as blood clots or tissue fragments during short-term cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system. This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or ... Read More