Tagged Articles

risk of death 14 articles

FDA finds no increased risk of death, cancer with Plavix

Long-term use of the blood thinner Plavix (clopidogrel) does not increase the overall risk of death in patients who have or are at risk for heart disease, nor are they at increased risk of cancer or death from cancer, according to a Food and Drug Administration (FDA) Safety Advisory. The announcement comes after an agency review of several long-term clinical trials evaluating rates of death, death from cancer, or cancer reported as adverse events. The FDA performed the meta-analyses of long-term clinical trials to assess the effects of Plavix on death rates from all causes. The results showed that long-term, ... Read More

FDA to review increased risk of death with long-term antiplatelet therapy

Long-term antiplatelet therapy with another blood thinning therapy has been shown to reduce the risk of heart attacks and the formation of blood clots in stents, but patients were at an increased risk of dying compared to patients on shorter therapy regimes, the Food and Drug Administration (FDA) announced in a Safety Advisory. The announcement is based on data from a clinical trial that compared long-term antiplatelet therapy of 30 months to patients on 12 months of therapy with either Plavix (clopidogrel) or Effient (prasugrel) in patients following implantation of drug-eluting coronary stents. The patients were also given dual antiplatelet ... Read More

EPA human test subjects were not always told of cancer, death risks

The Environmental Protection Agency (EPA) is being strongly encouraged to overhaul its guidelines for human test subjects after an investigation found that many of the people signed up to test the impact of pollutants for the agency were not always told about the risks of heavy exposure, which include cancer and death. Federal law allows the EPA to perform human testing in an effort to regulate potentially harmful pollutants. In a review of five studies conducted in 2010 and 2011, the EPA inspector general determined that, for the most part, the agency “followed applicable regulations” when it exposed 81 test ... Read More

Antibiotic Tygacyl gets new black box warning for increased risk of death

The Food and Drug Administration (FDA) is ordering the intravenous antibiotic Tygacyl (tigecycline) include on its safety label a new black box warning for increased risk of death compared to other antibacterial drugs. Tygacyl was given a fast-track approval by the FDA in 2005. The drug was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus and Acinetobacter baumannii. The drug was approved to treat complicated skin and soft tissue infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil is not approved for the treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia. ... Read More

Type 2 diabetes more deadly in young people than type 1 diabetes

People diagnosed with type 2 diabetes as adolescents or young adults are twice as likely to die early than people with type 1 diabetes, a new retrospective 20-year follow-up study reveals. Many diabetes experts find the information surprising. Type 1 diabetes has long been considered a more severe form of the disease primarily because patients require insulin for the rest of their lives and are at risk of hypoglycemia, or low blood sugar, which if severe can be deadly. However, people with type 2 diabetes, especially those who are diagnosed at a young age, are at greater risk for complications ... Read More

Children on dialysis living longer than in years past

Children on dialysis for end-stage kidney disease have a much lower risk of dying than they did 20 years ago, according to a new study published in the Journal of the American Medical Association (JAMA). Children on dialysis have a much shorter life expectancy than adults receiving dialysis treatment. These children already face 30 percent greater risk of death compared to healthy children. Dialysis is the only life-saving therapy for them as they wait for a kidney transplant. Researchers with Cincinnati Children’s Hospital Medical Center set out to determine if death rates had changed in these patients. Thus, they identified ... Read More

Study: Fresenius blood volume product increases risk of death in critically ill patients

A product made by Fresenius and B. Braun Holding to increase blood volume in critically ill patients increases the risk of death and kidney damage and should no longer be used, a researcher with the London School of Hygiene and Tropical Medicine recommended. Hydroxyethyl starch solution, also known as colloid fluid or crystalloid fluid, is used to stabilize patients with low blood pressure caused by conditions such as dehydration, blood loss, shock, and organ damage from blood infections. Hydroxyethyl starch is widely used in Europe, the UK and Canada, but not as popular in the U.S. An alternative fluid for ... Read More

Atrial fibrillation treatment digoxin tied to increased risk of death

A study published in the European Heart Journal says the heart drug digoxin, a treatment for the common irregular heart rhythm disorder known as atrial fibrillation, has been tied to a 41 percent increase in death. But researchers say the deaths my not entirely be the fault of digoxin. The study, conducted by researchers at the University of Kentucky, involved 4,060 atrial fibrillation patients. Half were prescribed digoxin while others were given different heart medications or treatments. During the course of the study 666 patients died and 375 of them had been on digoxin at their last follow-up visit. Researchers ... Read More

Johnson & Johnson to pay $181 million to 36 states, DC

Johnson & Johnson subsidiary Janssen Pharmaceuticals announced that it will pay about $181 million under a settlement and consent decree with 36 states and the District of Columbia over allegations that it illegally promoted and marketed Risperdal (risperidone). In July, sources suggested that Johnson & Johnson would pay as much as $2.2 billion to resolve the claims, including a criminal fine of as much as $600 million. The final sum, however, hinged on how many states would agree to the settlement. The lawsuit claims Johnson & Johnson paid kickbacks to a company that provided prescription drugs to nursing home patients ... Read More

Study of heart drug Multaq canceled due to two-fold risk of death

A clinical trial evaluating the effects of antiarrhythemic drug Multaq (Dronedarone) in patients with permanent atrial fibrillation was stopped prematurely after data showed a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving the drug compare to patients taking a placebo. Multaq is currently approved by the Food and Drug Administration (FDA) for use in a different, but related, condition. It is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter, with a recent episode of these conditions and associated ... Read More