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blood clots 301 articles

Alabama man files testosterone side effects lawsuit after suffering stroke

An Alabama man has filed a lawsuit against the makers of the testosterone replacement treatment Testim, claiming the drug caused him to have a stroke. Robert Hoehl, 64, had no history of cerebrovascular disease or neurological impairments when he began the hormone therapy in the fall of 2011. Less than a year later, he had a stroke. He immediately stopped taking Testim. Doctors noticed he had elevated hematocrit levels, a condition that can increase the risk of blood clots, heart disease and stroke. Hoehl’s blood levels were checked on a regular basis. Within months after quitting Testim, his hematocrit levels ... Read More

FDA approves Endo’s new Aveed testosterone injections

U.S. drug regulators gave Irish drugmaker Endo Pharmaceuticals the green light to manufacture and market its long-lasting testosterone injection Aveed in the United States, making it the latest addition to a growing list of testosterone-replacement therapies drug companies are aggressively marketing to men in the U.S. and other countries. Endo Pharmaceuticals said the U.S. Food and Drug Administration (FDA) approved Aveed to treat men with hypogonadism, commonly referred to as “low testosterone” or “low T,” a condition in which the body produces lower than normal levels of the hormone. Men with abnormally low testosterone levels often experience declines in muscle, ... Read More

FDA panel gives thumbs-down to new anti-platelet drug cangrelor

The new intravenous blood thinner cangrelor should not be approved for marketing because data from two separate clinical trials demonstrating the drug’s safety and efficacy were unconvincing and flawed, a Food and Drug Administration (FDA) advisory panel found. Cangrelor was being considered for two separate indications – to prevent blood clots associated with coronary stenting and in patients whose existing antiplatelet therapy is interrupted for surgery. Cangrelor is a member of the P2Y12 inhibitor class of antiplatelet agents, which also includes clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta). Committee member Stuart Rich, M.D., of the University of Chicago, expressed concerns ... Read More

Personal injury lawsuits piling up against makers of blood thinner Plavix

Personal and financial injury lawsuits involving the blood thinner Plavix are piling up in New Jersey against the drug’s makers, with 73 currently in the multidistrict litigation with at least another 14 being considered for transfer. The lawsuits allege the drug companies falsely advertised the prescription anti-clotting medication as a gentler-than-aspirin treatment designed to prevent heart attacks and strokes even though they knew the drug increased the risk for heart attacks, strokes, internal bleeding and death. Plavix, also known as clopidogrel, is manufactured and sold by Bristol-Myers Squibb and Sanofi-Aventis, and is aided by McKesson Corporation. The drug was approved ... Read More

$100 million offered to plaintiffs in NuvaRing blood clot lawsuits

Merck & Co. has agreed to pay $100 million to settle thousands lawsuits alleging the company’s contraceptive device NuvaRing caused life-threatening blood clots. The only caveat is that at least 95 percent of the eligible complainants must opt into the agreement otherwise no payouts will be made, a federal judge ruled. The deadline is March 10. U.S. District Judge Rodney Sippel called the settlement “a fair resolution of this litigation.” There are about 3,800 eligible participants in the settlement agreement, which includes more than 1,850 state and federal lawsuits as well as claims that have yet to be filed. NuvaRing is ... Read More

FDA reassessing testosterone drug safety

The U.S. Food and Drug Administration (FDA) said it plans to review the safety of testosterone replacement drugs after two separate studies indicated a higher risk of adverse cardiac events in men who used the products, including one report that linked the drugs to a doubled risk of heart attack. The agency said it is issuing the alert as it continues to “evaluate the information from these studies and other available data” that point to a significantly higher risk of “stroke, heart attack, and death in men taking FDA-approved testosterone products,” but advised that patients should not stop taking testosterone-enhancing ... Read More

Direct-to-consumer advertising likely inflating demand for testosterone drugs, new study finds

Testosterone replacement therapy for men increased in the U.S. and the U.K. between 2000 and 2011, but whereas supplementation rates quadrupled in the U.S. during that time, they rose just 30 percent in the U.K., according to a new study published in the Journal of Clinical Endocrinology & Metabolism. One likely explanation for the drastically different rates of low-testosterone treatment in the U.S. compared to the U.K. is the prevalence of direct-to-consumer (DTC) advertising in the U.S. DTC advertising has been legal in the U.S. since 1982, but few drug makers took that marketing approach due to requirements about disclosing ... Read More

Ariad Pharmaceuticals adds serious blood clot, heart failure risks to label of leukemia drug

Ariad Pharmaceuticals is re-launching its leukemia drug Iclusig (ponatinib) with new warnings about potential blood clots and the risk of heart failure. The Food and Drug Administration (FDA) ceased sales and promotion of the drug until the drug company addressed safety concerns including the danger of life-threatening blood clots associated with the medication. Iclusig is a treatment for two rare types of leukemia, chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with the chronic variety of the disease each year. Iclusig was approved by the FDA in late 2012 under the condition that it carry a ... Read More

Rate of blood clots with Thoratec heart pump device has increased dramatically

A higher rate of blood clots has been seen in patients who received the Thoratec Corp’s HeartMate II heart pump than was noted during clinical trials or from prior experience, and when blood clots do form they occur closer to when the device was implanted, according to a new study published in the New England Journal of Medicine. The HeartMate II is a left ventricular assist device (LVAD) that is used to assist the heart’s pumping function and keep alive patients who are either ineligible for or are awaiting a heart transplant. The device has helped significantly improve quality of ... Read More

European drug regulators launch investigation into safety of leukemia drug Iclusig

The European Medicines Agency has launched an in-depth review into potentially life threatening blood clots associated with the leukemia drug Iclusig (ponatinib). The move comes a month after the U.S. Food and Drug Administration (FDA) ordered Ariad Pharmaceuticals to suspend sales of the drug and halted clinical trials on the medication in the United States. Last month, Ariad Pharmaceuticals disclosed data from clinical trails that showed a higher rate of blood clots from Iclusig than what was seen in previous studies. In the new study, 11.8 percent of patients treated with Iclusig suffered a serious blood clot in an artery ... Read More