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venous thromboembolism 13 articles

Blood clot risk greatest during first six months of testosterone replacement therapy

Testosterone replacement therapy such as AndroGel and Axiron has been linked to a 63 percent increased risk of serious blood clots in the first six months of use, according to a new study published in the British Medical Journal. Blood clots associated with testosterone treatments form in the veins, a condition known as venous thromboembolism (VTE). These clots are the kind that can cause deep vein thrombosis, pulmonary embolism (blood clots in the lungs), leading to heart attacks, strokes, organ damage or death, according to the American Heart Association. “Risk peaks rapidly in the first six months of treatment and ... Read More

Blood clot risk with testosterone treatment highest during first six months of use

For men using testosterone replacement therapy, the risk of developing a potentially life threatening blood clot in the veins peaks within six months after starting treatment, according to a study published recently in the British Medical Journal. The case-controlled study involved more than 2.2 million men in the United Kingdom. Researchers found that men using testosterone supplements had a 63 percent increased risk of blood clots in the veins, or venous thromboembolism (VTE), in the first six months. The risk began to drop after six months of use and after treatment cessation. Researchers said further research was needed to confirm ... Read More

FDA says testosterone therapy serves little benefit to men

There is little evidence to show that testosterone replacement products serve any benefit to men, the Food and Drug Administration (FDA) announced this week. Testosterone treatments are prescribed to treat low testosterone levels in men resulting in symptoms such as fatigue, weight gain, muscle loss and low sex drive. Aggressive marketing campaigns from drug companies pushing testosterone products have resulted in skyrocketing prescriptions for testosterone drugs, leading some to wonder how many men are taking the drug who don’t really need it. This is especially worrisome considering two recent studies have linked testosterone supplement use to an increased risk of ... Read More

Nitroglycerin infusion recalled due to possible contamination

One lot of nitrogylcerin infusions used to treat heart patients is being recalled by the manufacturer because of possible contamination that could cause a blockage of blood vessels and other potentially serious health consequences. The recall involves nitroglycerin in 5% dextrose injection made by Baxter. The affected lot may contain particulate matter that if injected has the potential to cause venous and/or arterial thromboembolism, or a blockage of blood vessels. Other potential adverse events that can arise from the contaminated vials include inflammation, particularly in the lungs, and local irritation of blood vessels. Nitroglycerin in 5% dextrose injection is an ... Read More

Study: Pradaxa has little impact on atrial fibrillation patients

Pradaxa

The blood thinner Pradaxa (abigatran) was quickly adopted after its approval into clinical practice for stroke prevention in patients with atrial fibrillation, but a team of researchers say that it has had little impact on its target population. Lead author Dr. G. Caleb Alexander, a research scientist in the Johns Hopkins Bloomberg School of Public Health, and colleagues used data from the IMS National Disease and Therapeutic Index to quantify patterns of oral anticoagulant – both Pradaxa and long-used warfarin – use among study participants from 2007 until 2011. They found that despite rapid adoption of Pradaxa for its approved ... 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

FDA approves Ortho Evra’s new warning label

Johnson & Johnson, the makers of the Ortho Evra (norelgestromin/ethinyl estradiol) birth control patch, has updated the drug’s warning label to include new data on the odds ratio estimates of venous thromboembolism risk in women on Ortho Evra compared to users of oral contraceptives. The new label was approved by the Food and Drug Administration (FDA). Venous thromboembolism is a blockage of an artery in the lungs by fat, air, a blood clot or tumor cells. Oral contraceptives, such as Yaz, Yasmin and the generic Ocella, put women at risk for blood clots. The patch is no exception. In the ... Read More