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blood clots 301 articles

Oregon to offer birth control pills without prescription

Women in Oregon will now be able to get birth control pills without a prescription, thanks to a groundbreaking state law that will take effect later this year. Women who wish to obtain birth control without a doctor’s orders will be required to fill out a health questionnaire that would be examined by pharmacists who will determine whether the women should receive the pills. Pharmacists must first undergo specific training before they will be allowed to give birth control pills to women without prescriptions. Lawmakers have argued that requiring women to see a doctor in order to get a prescription ... Read More

Second patient dies during obesity drug study

A second patient has died in a late-stage clinical trial testing Zafgen Inc.’s experimental obesity drug beloranib , just two months after the Food and Drug Administration (FDA) halted part of the study to investigate what may have caused the first death. The second death occurred in an arm of the trial that was testing beloranib on patients with Prader-Willi Syndrome, a rare genetic disorder that causes constant, extreme hunger often resulting in life-threatening obesity. The patient was diagnosed with bilateral pulmonary emboli – blood clots in the lungs – during treatment, and subsequently died. In October, Zafgen informed the FDA ... Read More

Heart valves found not to work properly in many patients

The Food and Drug Administration (FDA) issued a safety communication alerting doctors that heart valves, which are implanted in hundreds of thousands of patients, do not always open and close properly, possibly because a blood clot has formed in the heart. These clots, they warn, could travel to the brain and cause a stroke. Despite this risk, the agency stressed that the valves still seem safe and are worth the risk. In recent years, more bioprosthetic aortic valves have been implanted. These are made from cow, pig or human tissue. They have been preferred over mechanical ones made from synthetic ... 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

FDA to consider review of first oral testosterone product

Just weeks after the Food and Drug Administration (FDA) ordered manufacturers of testosterone replacement therapies to collect data involving cardiovascular risks in patients who used their products, another drug company announced it was seeking FDA approval on a new oral testosterone supplement. Drug maker Lipocine announced it had submitted a new drug application (NDA) to the FDA for LPCN 1021, its experimental twice-daily, oral testosterone treatment. The drug is intended for men with conditions related to a deficiency or absence of endogeneros testosterone, a condition known as hypogonadism. The application for LPCN 1021 includes data from a pivotal Phase 3 clinical ... Read More

Bayer pays $57 million to settle Yaz blood clot lawsuits

Bayer Corp. says it will pay about $57 million to resolve about 1,200 federal and state lawsuits claiming its birth control pills Yaz, Yasmin and Ocella caused blood clots that led to heart attacks and strokes. The agreement would resolve lawsuits pending in a multidistrict litigation (MDL) in Illinois federal court as well as claims filed in Pennsylvania, New Jersey and California. Bayer has already paid about $2 billion to settle lawsuits alleging its contraceptives caused blood clots resulting in pulmonary embolisms and deep vein thrombosis. The latest settlement involves claims of more serious Yaz side effects from blood clots, including heart attacks and strokes. ... Read More

Study investigates testosterone side effects

Last year, the Food and Drug Administration (FDA) ordered manufacturers of testosterone replacement products to add blood clot warnings to the safety labels of the hormones. A new study suggests testosterone supplements may not increase the risk of blood clots, but the risk for heart attacks and strokes in patients who use the therapy remains. The most common forms of blood clots in the veins, also known as venous thromboembolism (VTE), are deep vein thrombosis (blood clot in the leg) and pulmonary embolism (blood clot in the lungs). It is the third most common cardiovascular problem after heart attacks and ... Read More

Federal judge sets trial date for Yaz personal injury lawsuit

An Illinois federal judge has set a June trial date for a lawsuit in a multidistrict litigation involving stroke risks with Bayer Healthcare Pharmaceuticals’ birth control pill Yaz, saying Bayer’s feet-dragging strategy in the litigation over the past six years appeared to be an attempt to shrink the number of lawsuits in the MDL through attrition. U.S. District Judge David R. Herndon said the drug company’s strategy in the Yaz personal injury lawsuit amounted to “wearing everyone down over time,” and to expedite the process, selected plaintiff Pamel Schuchert’s case to be tried. Schuchert, who joined the litigation in 2010, ... Read More

Testosterone increases colon cancer incidence in lab rats

The male hormone testosterone may cause cancerous tumor growth in the colon, according to new research. Researchers at the University of Missouri College of Veterinary Medicine observed normal levels of naturally occurring colon cancer in a group of male rats. When the testosterone was removed from those rats, colon cancer rates decreased dramatically. When the testosterone was reintroduced, the colon cancer rates returned to normal. It was previously thought that female hormones may have offered some protection against tumor susceptibility. “However, by showing that removing testosterone from rats leads to a dramatic decrease in colon cancer susceptibility, it appears that ... Read More

Europe’s drug authority considers heart risks with testosterone replacement therapy

European drug regulators are weighing whether the benefits of testosterone replacement therapy are worth the risk of life threatening cardiovascular events. Testosterone therapy, such as AbbVie’s AndroGel, is approved in both the United States and Europe for the treatment of hypogondaism, a condition in which the body does not produce enough testosterone. This can cause symptoms such as low sex drive and muscle loss. In recent years, makers of testosterone treatments have heavily marketed the drugs directly to consumers, asking men if they suffer from what they deem symptoms of “Low-T” – weight gain, fatigue, and general grumpiness. The campaign was ... Read More