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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

Controversy surrounds upcoming FDA decision on long-acting testosterone drug

The Food and Drug Administration (FDA) is expected to decide this week the fate of a long-acting testosterone product made by Endo Health Solutions, Inc. Aveed, indicated to boost testosterone in men with low levels of the hormone, has been rejected by the agency twice before based on health risks. Aveed, sold in other countries under the brand name Nebido, received mixed reactions from FDA advisors last year. The panel was split 9-9 on whether to recommend approval of the drug. Some advisors said the drug offers a valuable alternative to existing shorter-acting products, such as AndroGel, Testim and Axiron. ... Read More

Public Citizen urges FDA to add warnings of heart attack, stroke, death to testosterone treatments

Consumer advocacy group Public Citizen is petitioning the Food and Drug Administration (FDA) to require manufacturers of testosterone treatments to add black box warnings on the labels about the increased risk of heart attacks, stroke and death in men who use the treatment. Black box warnings are the strongest given by drug regulators and signify that medical studies indicate that a particular drug carries a significant risk of serious or even life-threatening adverse events. Testosterone supplements, including AndroGel, Testim and Axiron, are approved by the FDA to treat hypogonadism, a medical condition in which the testes produce little to no testosterone. ... 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

Pregnant women using SSRIs have double the risk of having a baby with heart defect

Using a common class of antidepressant while pregnant can double the risk of a child being born with heart defects, suggests a new study conducted by researchers in the United Kingdom. The research lends more weight to safety concerns over the use of antidepressants in pregnant women. The study focused on the most prescribed class of antidepressants – selective serotonin reuptake inhibitors, or SSRIs. Brand name SSRIs include Paxil, Zoloft, Celexa and Lexapro. Researchers say about two out of every 100 babies are born with a heart defect. However, if the mother is using an SSRI, the risk increases to ... Read More

Hospira recalls ovarian cancer drug due to visible particles in vials

Drug company Hospira, Inc., is recalling three lots of the advanced ovarian cancer treatment Carboplatin injection because of visible particles found in samples taken from the lots during a routine inspection. The particles have been identified as Carboplatin crystals. If injected into a patient, the particles may become lodged in and obstruct blood vessels, potentially causing local infraction, thromboembolism (blood clots), and vasculitis (inflammation of blood vessels). Over time, granulomatous, or a noncancerous inflammation in the tissue, can form in the lungs. Hospira issued the updated recall notice just five months after it issued a recall notice on 19 lots ... Read More

Defective diagnostic tests recalled

Devices used by medical professionals to diagnose conditions such as heart failure, heart attacks and blood clots in the lungs are being recalled because they may give false positive or false negative readings. The recall was initiated because the false readings have caused some patients to receive inappropriate clinical management. The recall involves specific Alere, Triage tests including the CardioProfiler Panels, Cardiac Panels, Profiler SOB Panels, BNPs, and D-dimers. It is listed as a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the products ... Read More

Blood clots linked to contraceptive patches, rings

Lawsuits and bad press over Yaz birth control pills have brought attention to the dangerous risk of blood clots with oral contraceptives. But a new Danish study suggests that non-oral forms of hormonal contraceptives may be just as, if not more, dangerous. Contraceptives that use hormones, including pills, patches and rings, often carry some risk for blood clots. Blood clots are serious health issues. If they break free and travel to the heart, lungs or brain, they can trigger heart attacks, pulmonary embolism, or strokes, all of which can be deadly. Yaz made news in recent years because studies showed drospirenone, ... Read More

Two studies show dangers of SSRI use during pregnancy

Using antidepressant known as selective serotonin reuptake inhibitors, or SSRIs, during pregnancy can increase the risk of various birth defects, whether the drugs are used early or late in pregnancy, according to two studies published in the past six months. The first study, published in July 2011, was conducted by Finnish researchers who found that exposure to SSRIs in the first trimester of pregnancy increases the risk for major congenital anomalies, particularly heart problems. The second study, published earlier this month in the British Medical Journal, revealed that women who used SSRIs were at risk of delivering a baby with ... 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