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dying 14 articles

FDA rejects consumer group’s request for black box warning on statin drugs

Cholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys. Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The ... Read More

Testosterone supplementation in canaries could shed light on sexual effects of the drug in humans

Injecting testosterone into areas of the male canary’s brain increases the frequency – but not the quality – of the bird’s singing and could help explain the sexual effects of the male hormone in humans, according to a study recently published in the journal Proceedings of the National Academy of Sciences. In order to understand how testosterone affects a male bird’s singing, researchers with Johns Hopkins University divided 20 canaries into three groups. The first group received injections of testosterone in a part of the brain called the medial preoptic nucleus, or POM, which controls sexual motivation. The second group ... Read More

Death rate among dialysis patients dropping, but still higher than general population

Fewer people with end-stage renal disease and who may also be on dialysis are dying, however the rate of death among those populations remains much higher than the general population, according to the 2013 Annual Data Report from the U.S. Renal Data System. The death rate of patients with end-stage renal disease dropped more than 30 percent from 1996 to 2011. During that same time, the mortality rate among the dialysis population dropped more than 26 percent. According to the data, among patients an average of 65 years of age, dialysis patients overall had an expected 6.2 years of remaining life, compared to the ... Read More

FDA panel votes to loosen restrictions on Avandia despite heart attack risk

An advisory panel to the Food and Drug Administration (FDA) voted to recommend that the severe restrictions the agency placed on the type 2 diabetes drug Avandia be loosened. The vote was far from unanimous, with five members voting to keep the tight restrictions on Avandia and one member (the consumer representative) calling for the withdrawal of the drug. Avandia, also known as rosiglitazone, was a top-selling diabetes medication until, in 2010, the FDA placed severe restrictions on the medication based on studies that showed the people who took the medication were at greater risk of dying from a heart ... Read More

Drug company fined $45 million for illegally marketing weight gain drug to elderly, hospice patients

Par Pharmaceutical Cos., has been ordered to pay $45 million to resolve charges that it improperly marketed its weight-gain drug to nursing home residents and dying hospice patients who are more at risk of experiencing side effects, a federal court ruled. The company makes Megace ES, a drug approved in 2005 to treat anorexia and malnutrition in AIDS patients. Significant weight loss represents a serious risk in patients with AIDS, and can worsen the illness, cause physical impairment, decrease tolerance of some therapeutic agents, and lead to an increased susceptibility to infection. Megace ES is a concentrated form of the ... Read More

Native Americans more likely to need dialysis

Native Americans make up just 1.5 percent of the U.S. population, but they have one of the highest rates of end-stage renal disease. Patients with end-stage renal disease need dialysis or a kidney transplant in order to survive. Dialysis is the artificial process of getting rid of waste and unwanted water from the blood. This process is done naturally by the kidneys, but people with damaged or failed kidneys often need dialysis to regulate body levels of water and minerals, and to remove waste. Without dialysis, the amount of waste products in the blood would increase and eventually reach levels ... Read More

FDA investigates makers of dialysis treatment linked to hundreds of sudden deaths

The nation’s largest operator of dialysis centers is under investigation by the Food and Drug Administration (FDA) for failing to warn patients that use of one of their products could be deadly. Fresenius Medical Care treats more than 130,000 of the estimated 400,000 Americans who receive dialysis. The company also is the leading supplier of dialysis machines and disposable products to other dialysis clinics across the country. Last November, the company’s medical office sent an internal memo to doctors at its clinics warning that improper use of one of its products could be the cause of a stark increase in ... Read More

GSK to pay highest-ever award in Israeli court for concealing risks with diabetes drug

The highest-ever compensation in an Israeli class-action lawsuit against a drug manufacturer was awarded this week to a diabetes patient who claimed the company failed to disclose that its type 2 diabetes drug increased the risk of cardiovascular events. The lawsuit claimed that GlaxoSmithKline (GSK) concealed data from the public that showed its blockbuster drug Avandia increased the risk of dying of a heart attack. Under the compromise agreement, GSK was ordered to pay NIS 12.1 million – or $2.6 million. The award is expected to be used to fund a new treatment program for diabetics. In May 2007, the ... Read More

Newer blood thinners may increase risk of brain bleeds

Merck’s experimental blood thinner Vorapaxar shows promise in significantly reducing the risk of dying from heart attack or stroke, but the associated risk of hemorrhage has some experts wondering if the drug will make it past United States drug regulators. Vorapaxar is an anti-platelet medicine that works differently that aspirin or the popular warfarin (Coumadin). It is in a new class of medications known as thrombin receptor antagonists, which work by stopping a process that normally allows the blood’s platelets to stick together and form clots. The medication is designed to prevent heart attacks and strokes and was tested in ... Read More

Aspirin therapy may help reduce risk of cancer, prevent spread of disease

Daily low-dose aspirin therapy may hold even more health benefits than previously thought, according to new studies. A daily dose of aspirin may reduce a person’s chance of developing or dying of cancer, and can prevent tumors from spreading, the studies say. Aspirin therapy is often prescribed for patients who have had or are at risk for heart attack and stroke. It works by interfering with the blood’s clotting action. Clots can form when a fatty deposit in the arteries bursts. When clots lodge in the artery, they can cause a heart attack or stroke. Recent studies have shown that ... Read More