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blood clots 301 articles

New black box warning added to blood thinner Eliquis

The blood thinner Eliquis (apixaban) has a new black box warning that prematurely discontinuing therapy for reasons other than pathological bleeding or completion of a course of therapy increases the risk of blood clots. If therapy is prematurely discontinued, it is advised that patients be given another anticoagulant to prevent this risk. Eliquis is used to reduce the risk of strokes or blood clots in patients with a common heart rhythm abnormality known as atrial fibrillation, not caused by a heart valve problem. It is also approved to prevent and treat blood clots in the veins of the legs, known ... Read More

Women should not be treated with testosterone therapy, Endocrine Society advises

Low testosterone is not a valid diagnosis in healthy women, and most women with low amounts of the hormone should not use testosterone-replacement drugs, the Endocrine Society said in a new guideline. “Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” guideline task force chair Dr. Margaret Wierman, of the University of Colorado, said in news release. Dr. Wierman said that in a review of past studies, women who had low testosterone levels did not exhibit any signs ... Read More

Abbott, AbbVie face varying lawsuits with AndroGel

Abbott Laboratories and AbbVie skirted racketeering claims alleging the companies made health plans pay unnecessarily for the arthritis drug Humira and the testosterone replacement AndroGel instead of less expensive generics. U.S. District Judge Robert Dow said plaintiffs New England Carpenters Health and Welfare Fund failed to show that the defendants teamed up with pharmacies and intermediaries to illegally increase sales of the drugs by offering savings cards or coupons to reduce copayments. The fund also accused Abbott and AbbVie of insurance fraud, alleging the companies instructed pharmacies to hid subsidies by processing them as secondary insurance rather than discounts. “While ... Read More

New Jersey man blames heart attack on Axiron testosterone treatment

New Jersey resident Patrick Miller was 54 when he started using Axiron, a testosterone replacement product used to treat men who have low levels of the hormone in their blood. A month later, on Oct. 3, 2012, he had a heart attack. Thirteen months later, the Journal of the American Medical Association (JAMA) published a study that found men who used testosterone treatments have a 30 percent increased risk of having a heart attack, stroke or dying. And, in January 2014, the journal PLOS One found a two-fold increased risk of heart attack among older men in the first 90 days ... Read More

Experts: testosterone treatments vastly overprescribed

Nearly 3 percent of American men aged 40 and older – about two million men – received prescriptions for testosterone replacement treatments in 2011 – three times more than a decade earlier, raising concerns that the drugs may be overprescribed. Testosterone therapy is intended for men who suffer from low testosterone levels, a condition known as hypogonadism, caused by damage or disease in their testes or other parts of the endocrine system. This can cause symptoms such as low sex drive, muscle loss, weight gain and fatigue. Testosterone levels typically drop as a man ages. But many middle-aged and older ... Read More

Panel recommends more studies on cardiovascular risks with testosterone drugs

Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended. The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients. The FDA is ... Read More

Feds want to limit prescribing of testosterone replacement drugs

The indication for testosterone replacement treatments should be scaled back so that fewer men are prescribed them because the drugs do little to counter the signs of aging, a federal advisory panel announced. The group voted 10-1 to recommend that the prescribing language on testosterone supplements be revised to make it clear that the drugs have not been shown to reverse common symptoms of aging such as low libido, muscle loss, weight gain and fatigue. The new wording would limit the drug only for men who have abnormally low hormone levels due to disease or injury. Testosterone levels typically drop ... Read More

FDA panel recommends severely limiting testosterone drug prescriptions

A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... Read More

Lawsuit filed against Pfizer related to testosterone replacement drug

Pfizer’s testosterone replacement treatment Depo-Testosterone has become the subject of lawsuits questioning the safety and efficacy of the drugs after reports of heart attacks, strokes and blood clots in patients treated with the hormone. The lawsuit filed on behalf of Alvaro Roman Gutierrez alleges that Pfizer and its unit Pharmacia & Upjohn Co. LLC, conducted a “disease mongering” campaign to exaggerate the problem of low testosterone levels in men in order to boost sales of Depo-Testosterone. Gutierrez claims that Pfizer and Pharmacia & Upjohn spent millions of dollars to promote its drug to consumers and, along with other drug companies not ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

The U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.” FDA officials added briefing documents to the agency website earlier this month, acknowledging that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, such as testicular and pituitary disease. Still, as the agency notes, testosterone ... Read More