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VTE 10 articles

Dangerous blood clots more likely during first six months of testosterone treatment

Men using testosterone replacement therapy have a 63 percent increased risk of developing life threatening blood clots during the first six months of treatment, but this testosterone side effect may have run under the radar in previous studies due to methodological issues, according to a study published in the British Medical Journal. Blood clots that start in the vein are called venous thromboembolism (VTE). The two types of VTE include deep vein thrombosis (DVT), a clot in the deep vein, usually the leg but can be in the arm or other veins; and pulmonary embolism (PE), when a DVT clot ... Read More

Multiple IVC Filter Arms Fracture, Travel Through Patient’s Heart

Inferior vena cava (IVC) filters are a life saver for some, a life threat for others. The devices are cage-like in appearance, with metal wire legs that are meant to catch a blood clot before it reaches the heart or lungs. The filter is deployed using a sheath that is inserted into the largest vein in the body, the vena cava. Previously, IVC filters were permanent for the most part, used primarily in patients who could not tolerate anticoagulation medication. Medical device manufacturers such as C.R. Bard, Johnson & Johnson’s subsidiary Cordis, and Cook Medical have created a cheaper model intended to be temporary. ... Read More

Study: Testosterone replacement therapy ups blood clot risk as much as 63 percent

Men who use testosterone replacement therapy have a 63 percent increased risk of developing a life-threatening blood clot in a vein, and the risk peaks rapidly during the first six months of use, according to a study led by Dr. Carlos Martinez of the Institute for Epidemiology, Statistics and Informatics in Frankfurt, Germany. Blood clots in the veins, a condition known as venous thromboembolism (VTE), is serious. The clot can travel to the heart and cause a heart attack, to the brain and cause stroke, or to the lungs, a condition known as pulmonary embolism. All of these blood clot-related problems ... Read More

New testosterone replacement therapy users at greater risk of blood clot-related health problems

Men who use testosterone replacement therapy have a 63 percent increased risk of having a blood clot-related heart attack, stroke, organ damage or death within the first six months of treatment, a new study has found. “Risk peaks rapidly in the first six months of treatment and lasts for about nine months, and fades gradually thereafter,” said Dr. Carlos Martinez with the Institute for Epidemiology, Statistics and Informatics in Frankfurt, Germany. Martinez is the lead author of the study, which was published in the British Medical Journal. Testosterone treatments are used by millions of men. The hormone replacements are intended ... Read More

New blood clot warning with NuvaRing contraceptive device

A new warning has been added to the safety label of the NuvaRing contraceptive vaginal ring, alerting health care providers and women that the birth control method should be discontinued if symptoms of blood clots are experienced. Symptoms of blood clots include chest pain; shortness of breath; upper body discomfort such as in the arms, back, neck or jaw; redness, warmth or swelling in the lower leg; headaches; speech changes; paralysis, dizziness; or trouble speaking. “Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs,” the warning reads. “Stop NuvaRing use if there is unexplained loss of ... Read More

Pradaxa safety issues cause delay in new blood thinner approval

Safety issues following the October 2010 approval by the Food and Drug Administration (FDA) of the blood thinner Pradaxa are being blamed for the three-month delay in the decision on a new blood thinner. Apixaban (Eliquis), made by Pfizer and Bristol-Myers Squibb, was set for FDA review in March but regulators opted to extend the deadline. The FDA had previously granted the application of a six-month priority review, which would have resulted in a decision by March 28. The new decision date is June 28. Eliquis is an anticoagulant indicated for the prevention of stroke in patients with a type ... Read More

Why would FDA panel not ban Yaz over blood clot risk?

Why did an advisory panel of experts for the Food and Drug Administration (FDA) not vote to ban the popular birth control pill Yaz and other pills of its generation containing the hormone drospirenone, instead opting to recommend that the pills carry a stronger warning for life-threatening blood clots? There is no doubt that with all oral contraceptives there is a slight risk for blood clots. Bayer, maker of Yaz and a family of other drospirenone-containing pills such as Yasmin, Beyaz and Safyral, has consistently claimed its pills were no more as dangerous than other birth control pills. However, newer ... Read More

FDA warns of elevated blood clot risk in Yaz birth control pills

Two new studies showing an increased risk in venous thromboembolism (VTE), or blood clots in the lungs, in women who use Yaz birth control pills and oral contraceptives with similar hormone formulations, has resulted in a special drug safety notification from the Food and Drug Administration (FDA). Yaz, made by Bayer, contains the progestin drospirenone. The same hormone is used in Bayer’s Yasmin, Beyaz and Safyral, as well as generics such as Ocella, Gianvi, Loryna, Syeda, and Zarah. The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking ... Read More

Ortho Evra birth control patch warning upgraded to a black box warning

A new black box warning has been added to the safety label of Johnson & Johnson’s birth control patch Ortho Evra (norelgestromin/ethinyl estradiol), alerting consumers that women aged 15-44 who use the patch may be at greater risk for life-threatening blood clots compared to women of the same age who take oral contraceptives. The boxed warning also informs users that cigarette smoking while using the patch puts them at greater risk for heart attacks. While the boxed warning regarding cigarette smoking and cardiovascular risk is consistent with the current labeling for other combination hormonal contraceptives, the boxed warning for blood ... Read More

Women more at risk of blood clots during first six months on ‘The Pill’

Women who use birth control pills are at greater risk for developing blood clots during the first six months of oral contraceptive use, and they are at even greater risk when first starting the pill and when restarting the same pill or a different pill after a four-week or greater break. The interim data comes from a large, prospective, observational cohort safety study on the increased risk of venous thromboembolism (VTE), or blood clots, in women who use birth control pills. The study was funded by Bayer HealthCare Pharmaceuticals Inc., makers of Yaz, one of the most popular brands of ... Read More