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blood clots 301 articles

Testosterone replacement therapy injury lawsuits consolidated in federal court

Federal lawsuits against manufacturers of testosterone replacement therapies alleging the companies withheld risks associated with the products will be consolidated in the U.S. District Court for the Northern District of Illinois. The U.S. Judicial Panel on Multidistrict Litigation (MDL) ordered all federal lawsuits involving testosterone supplements be tried in Chicago. Consolidating the lawsuits is intended to reduce the cost of expert discovery, facilitate the establishment of a uniform pretrial approach to the cases, reduce the potential for inconsistent rulings and conserve resources, the MDL panel wrote. Testosterone replacement therapies, including the widely prescribed AndroGel, Testim and Axiron are designed to boost ... Read More

Merck reaches $100 million settlement in NuvaRing side effects lawsuits

A $100 million settlement involving life threatening side effects from Merck’s NuvaRing birth control device will stand now that a vast majority of claimants have agreed to the terms of the settlement. The settlement was approved by U.S. District Judge Rodney W. Sippel of St. Louis in February; however, Merck had the opportunity to abandon the deal if it did not get at least 95 percent of the claimants to sign off on the terms. About 3,800 people will share in the settlement. NuvaRing was approved as a contraceptive device in 2002 by the Food and Drug Administration (FDA). It ... Read More

FDA lifts clinical hold on experimental pancreatic cancer treatment

The Food and Drug Administration (FDA) has removed a clinical hold on patient enrollment and dosing of PEGPH20 in a Phase 2 trial evaluating the drug in patients with pancreatic cancer. The study will resume under a revised protocol. In April, the FDA placed the clinical hold following Halozyme Therapeutics’ decision to temporarily halt enrollment and dosing of the drug in order assess thromboembolic event risks in patients treated with the drug. “Pancreatic cancer has one of the lowest survival rates of any cancer,” Dr. Helen Torley, President and CEO of Halozyme, said at the time. “We remain committed to ... Read More

Drug to treat rare disorders recalled for third time since August

Alexion Pharmaceuticals has issued the third recall since August of its sole approved drug Soliris after visible particles were seen in some vials during periodic testing. If injected, the particles could pose safety risks to patients in two general areas – first it could cause immune reaction and blood clots. Secondly, particles could cause blockage of blood flow in vessels, which could be life threatening. Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening blood disease; and patients with atypical hemolytic uremic syndrome, (aHUS), a rare disease in children that causes ... Read More

Men should take steps before going on testosterone replacement therapy

Men who are experiencing symptoms of low testosterone, such as low sex drive, fatigue, weight gain and loss of muscle mass, should take key steps before they begin testosterone replacement therapy, as the treatment has been linked to an increased risk of cardiovascular events and death, doctors warn. The first step is to have a blood test to check their testosterone levels. The test should be performed twice, each time in the morning between 8 a.m. and 10 a.m., in order to confirm the results. If the tests show low testosterone, the next step is to determine the cause. “The ... Read More

Blood thinner Pradaxa linked to greater risk of major gastrointestinal bleeding events

The blood thinner Pradaxa (dabigatran) can help prevent strokes and death better than the long-used warfarin, however it puts users at greater risk for dangerous gastrointestinal bleeding events, according to a Food and Drug Administration (FDA) Drug Safety Communication. Both Pradaxa and warfarin are used to reduce the risk blood clots that can lead to strokes in patients with a common type of heart rhythm abnormality called non-valvular atrial fibrillation. Warfarin has been used for more than 50 years, but patients require regular monitoring due to the bleeding risks. Pradaxa was approved in 2010 and became the first anticoagulant alternative ... Read More

Testosterone drugs may seriously harm some patients, doctor warns

National Public Radio (NPR) recently called testosterone replacement drugs “the biggest men’s health craze since Viagra,” but some doctors warn that the supplements could be anything but healthy for some men. The Louisiana State University (LSU) Health Sciences Center in New Orleans recently reported that resident urologist Harold Fuselier warns that testosterone-replacement drugs, which are now widely available in topical gels, creams, and patches, could have serious, even deadly, side effects. It’s an especially important warning to consider, given the proliferation of television, web, and print advertisements touting the advantages of drugs that artificially boost low testosterone levels, often referred ... Read More

Mildly low testosterone levels do not typically require replacement therapy

Testosterone replacement therapy may be recommended to treat men with very low testosterone levels but it is not typically recommended for older men who are otherwise healthy even if their hormone levels are slightly below what is considered normal, according to Dr. Todd Nippoldt, an endocrinologist with Mayo Clinic. A reader posed the question to Medical Edge from Mayo Clinic about whether he should consider testosterone therapy after a blood test revealed his levels of the hormone were slightly below average. “Should I talk to my doctor about getting treatment even if I don’t have symptoms?” Mildly low levels of ... Read More

Merck offers $100 million to settle NuvaRing lawsuits

Plaintiff’s lawyers are meeting in Las Vegas this week to determine whether enough claimants opted in on a $100 million settlement offered by Merck & Co. for its contraceptive NuvaRing, which has been linked to life threatening blood clots. Under the agreement, 95 percent of the estimated 3,800 claimants must opt in. The average payment would be about $58,000, however each claim would be reviewed by attorneys using a formula that adds points based on injuries, and subtracts points for those who are smokers or who are underweight. Lawyers representing women who have filed NuvaRing lawsuits against Merck & Co. ... Read More

FDA sued for failure to publish approval of generic testosterone drug

Multinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone gel product, even though it had received FDA approval. Ireland-based Perrigo, the largest manufacturer of private label over-the-counter prescription drugs in the United States, said that the FDA failed to update its “Orange Book” listing Approved Drug Products with Therapeutic Equivalence Evaluations. As a result, Perrigo’s testosterone-replacement gel, a generic equivalent of AbbVie’s AndroGel, is not included in the FDA’s therapeutic equivalents (TE) – ... Read More