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cardiovascular events 70 articles

Federal judge says Lilly cannot stop sales of generic versions of Axiron

Eli Lilly and Co. and its partner Acrux cannot stop competitors from selling generic versions of its testosterone treatment Axiron, a federal judge in Indianapolis ruled. Melbourne, Australia-based Acrux developed Axiron. Lilly, based in Indianapolis, has the exclusive rights to market the drug. The hormone replacement therapy product generated $29.3 million in global sales for the second quarter of 2016. The two companies filed a lawsuit last summer against a group of generic drugmakers including Perrigo Co., Actavis Laboratories and Lupin Pharmaceuticals, for infringing on their patent. U.S. Judge Sarah Evans Barker concluded that a formulation patent originally granted for the ... Read More

New boxed warnings added to prescription NSAIDs

The safety labels for prescription painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs) have been updated to include a new black box warning for risk of serious cardiovascular and gastrointestinal events. Boxed warnings are the most serious type of warning issued by the FDA and involve situations in which there is a significant risk of serious or even life-threatening adverse events. The boxed warnings state the following: Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may occur early in treatment ... Read More

FDA withdraws approval of niacin, fenofibric with statins

The Food and Drug Administration (FDA) is withdrawing its approval of niacin extended-release (ER) tablets and fenofibric acid delayed release (DR) capsules with cholesterol-lowering statins, saying that based on the outcome of cardiovascular studies on the medications, the benefits of niacin or fenofibric when taken with statins no longer outweigh the risks. The agency concluded that there is no longer scientific evidence that the drugs, when used with statins, reduce triglyceride levels or increase HDL cholesterol levels resulting in a reduced risk of cardiovascular events. Niacin, also known as vitamin B3 and nicotinic acid, and is often used in patients ... Read More

Older men on testosterone replacement therapy may enjoy better sex, but have greater heart risk

Men older than 65 on testosterone replacement therapy to boost their hormone levels to that of much younger men enjoy a spike in libido, sexual activity and mood, but the side effects remain a concern, according to a new testosterone study published in the New England Journal of Medicine. The new study, dubbed the Testosterone Trials (TTrials) was led by researchers from the University of Pennsylvania and included 790 men who were randomized to use either AbbVie’s Androgel topical testosterone gel for one year, or a placebo for a year. Participants were evaluated four times during that time and filled out ... Read More

Testosterone therapy makers face thousands of lawsuits

Steve Schabel, a married father of three, said he began testosterone therapy in 2013 to treat depression and boost his sex drive. He started with the gel and then switched to an injection. A week later, he was hospitalized with a life threatening double pulmonary embolism, or blood clots in the lungs. Shabel had no prior history of heart problems. He has recovered but must take blood thinners for the rest of his life. He is now one of several men who is suing the manufacturer of his testosterone replacement treatment claiming the company engaged in questionable marketing practices to ... Read More

Roberts says he would use testosterone therapy despite serious health risks

Morning Joe panelist Thomas Roberts says he would “live today, I will borrow from tomorrow” and take testosterone replacement therapy to boost his levels of the manly hormone if his levels were low, despite serious risks with the drugs including heart attacks, strokes and death. Roberts made the comment during Morning Joe’s segment on Time’s cover story “Manopause,” which addresses skyrocketing sales of testosterone supplements and health risks associated with the drugs. “We only got the now. I don’t know what’s going to happen tomorrow,” he said. Roberts is obviously being lured by television advertisements from drug companies that ask men ... Read More

Fresenius faces more than 5,500 NaturaLyte, GranuFlo lawsuits

Fresenius Medical Care, the world’s largest provider of dialysis services and products, is facing more than 5,500 lawsuits alleging the company’s dialysis concentrates caused patients to suffer sudden cardiac arrest. The lawsuits claim that the company’s products NaturaLyte and GranuFlo, used at Fresenius dialysis clinics and other medical facilities not owned by Fresenius, were inadequately labeled, resulting in bicarbonate toxicity in patients, which increased the likelihood that they could suffer from serious and often fatal cardiovascular events, including heart attacks and cardiac arrest. The lawsuits allege that Fresenius discovered that instructions on its GranuFlo and NaturaLyte products could be confusing ... Read More

Louisiana AG lawsuit claims Fresenius products caused fatal heart attacks in dialysis patients

The Louisiana Attorney General has filed a lawsuit against Fresenius Medical Care North America and the nearly 100 Fresenius-owned dialysis clinics in the state alleging that its dialysis concentrates GranuFlo and NaturaLyte contributed to fatal heart attacks of dialysis patients. The lawsuit, filed in state district court in Baton Rouge, claims Fresenius violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents with confusing labeling on its dialysis products, which resulted in patients suffering sudden cardiac arrest. Louisiana seeks civil penalties of $5,000 per violation and is asking the court to force Fresenius to pay ... Read More

FDA finds cardiovascular risk with blood pressure medication used by diabetics is inconclusive

There is no clear evidence that the blood pressure medication olmesartan increases the risk of cardiovascular events in diabetic patients, the Food and Drug Administration (FDA) said in a Drug Safety Communication. The FDA began a safety review of olmesartan in 2010 after results from the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial raised cardiovascular risk concerns. The clinical trial was designed to see whether olmesartan could delay kidney damage in patients with type 2 diabetes. There was an unexpected finding of an increased risk of cardiovascular death in patients treated with olmesartan compared to patients given a ... Read More

New blood clot warnings added to testosterone replacement therapies

Testosterone treatments have been linked to dangerous blood clots in the legs, adding more safety concerns to the hormone supplement currently under review for increasing the risk for strokes, heart attack and death. The Food and Drug Administration (FDA) announced that it was ordering a new warning for deep vein thrombosis be added to the safety labels of testosterone treatments. Deep vein thrombosis is a blood clot that forms in a vein deep in the body. It mainly affects the large veins in the lower leg and thigh. It is a serious condition because blood clots in veins can break ... Read More