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Pharmaceutical 3429 articles

Beasley Allen has one of the largest and most technologically advanced Mass Torts practices in the country. The Mass Torts division represents numerous people in claims against companies that manufacture and/or market defective pharmaceuticals and/or medical devices. The resources devoted to this division allow the firm to competently and conscientiously handle any group of cases, no matter how large, along with particular catastrophic injury cases.

Our firm was recently involved in one of the greatest victories in Mass Torts history, against drug manufacturer Merck regarding the drug Vioxx. After more than five years of hard-fought and difficult litigation, Merck agreed to pay $4.85 billion, the largest pharmaceutical settlement in U.S. history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack, including sudden cardiac death, or a stroke.

Bleeding risks associated with new blood thinners Xarelto, Pradaxa

xarelto

Advertisements warning of bleeding risks with new blood thinners including Pradaxa and Xarelto leave many people asking if the drugs are worth the risk. Blood thinners, also called anticoagulants or antiplatelets, are often prescribed to patients with some heart or blood vessel diseases, or for people with poor blood flow to the brain. These drugs reduce the risk of heart attack and stroke by reducing the formation of blood clots in the arteries and veins. There are two main types of blood thinners – anticoagulants and antiplatelets. Anticoagulants include the drugs heparin and warfarin, which work on chemical reactions in ... Read More

FDA warning about cancer spread with morcellator gynecological tool comes 20 years too late

morcellator

For many people, the Food and Drug Administration’s warning to physicians to stop using a morcellator, a type of surgical tool used in about 50,000 gynecological procedures annually in the United States, seemed to come out of nowhere. But the message was startling: Use of the device could result in the spread of hidden cancer and, ultimately, worsen the odds of a patient’s survival. The warning was issued last month after multiple cases emerged this year of women whose cancers were worsened after undergoing hysterectomies or myomectomies (uterine fibroid removal) with a surgical tool known as a laparoscopic power morcellator. ... Read More

FDA to push drugmakers to provide latest drug safety information electronically

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Pharmaceutical companies must provide health care providers with the latest available drug safety information via real-time electronic updates, according to a new rule proposed by the Food and Drug Administration (FDA). “This would ensure that the most up-to-date version of the prescribing information is available to health care professionals and the public,” the rule states. The new guidelines require drug makers to include a link on their drugs’ safety labels and outside packaging of the products that connects directly to a publicly accessible online repository with the drug’s most current instructions, including dosage recommendations, adverse events, and contraindications or drug interactions. The new ... Read More

Baxter recalls sodium chloride electrolyte solutions

By LeoCarbajal (Own work) [CC-BY-SA-3.0 (http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

Baxter International, Inc., is recalling two lots of 0.9 % Sodium Chloride injection in 100 mL MINI-BAG PLUS containers after two complaints of particles floating in vials. The particulate has been identified as a fragment from the vial adapter. The intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material and the patient’s underlying medical condition. Without in-line filtration, particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolism (blockage of ... Read More

The Doctors warn women of ovarian cancer risk with talcum powder products

baby powder contains talc

Physicians on The Doctors talk show are warning women that using talcum powder products in the genital area for personal hygiene can increase a woman’s chances of developing ovarian cancer. This week, The Doctors introduced Deane, who won the first major lawsuit against Johnson & Johnson claiming the company knew of the risks associated with its baby powder and Shower to Shower body powder but failed to warn consumers of the risks. Deane said when she was first diagnosed with ovarian cancer, she searched for some understanding about how she could have developed the disease. “I had no family history. ... Read More

Compounding pharmacy owners, employees face criminal charges in fungal meningitis outbreak

Syringe

Two officials with the Massachusetts compounding pharmacy that caused a multistate outbreak of deadly fungal infections in 2012 have been charged with criminal activity including second-degree murder. The 131-count indictment lays out charges against the company’s co-founders and 12 other employees of the New England Compounding Center (NECC), which produced about 18,000 contaminated steroid shots and shipped them to medical facilities in 23 states. The shots, used to treat back, neck and joint pain, sickened more than 750 people with fungal infections including fungal meningitis, and killed 64. Co-founder Barr Cadden and senior pharmacist Glenn Chin were charged with the ... Read More

FDA strongly discourages keepsake fetal heartbeat monitoring, ultrasound images

ultrasound keepsake - FDA image

The Food and Drug Administration (FDA) is strongly discouraging pregnant women from getting keepsake heartbeat and ultrasound images and videos of fetuses because it could heat and damage tissue, which could be hazardous to unborn babies’ health. “Although there is a lack of evidence of any harm due to ultrasound imaging and heartbeat monitors, prudent use of these devices by trained health care providers is important,” says Shahram Vaezy, PhD, an FDA biomedical engineer. “Ultrasound can heat tissues slightly, and in some cases, it can also produce very small bubbles (cavitation) in some tissues.” The long-term effects of tissue heating ... Read More

Statin therapy linked to serious cataracts

lipitor

People who use cholesterol-lowering statin medication are at greater risk of developing cataracts severe enough to require surgery, according to two studies. Researchers say the findings suggest more research is warranted “especially in light of increased statin use for primary prevention of cardiovascular disease and the importance of acceptable vision in old age, when cardiovascular disease is common,” researchers wrote. The study is published in the December 2014 issue of the Canadian Journal of Cardiology. One of the cohorts involved 162,501 men and women who during follow-up visits with ophthalmologists from 2000 to 2007 became candidates for surgery to correct ... Read More

Testosterone increases colon cancer incidence in lab rats

Low T

The male hormone testosterone may cause cancerous tumor growth in the colon, according to new research. Researchers at the University of Missouri College of Veterinary Medicine observed normal levels of naturally occurring colon cancer in a group of male rats. When the testosterone was removed from those rats, colon cancer rates decreased dramatically. When the testosterone was reintroduced, the colon cancer rates returned to normal. It was previously thought that female hormones may have offered some protection against tumor susceptibility. “However, by showing that removing testosterone from rats leads to a dramatic decrease in colon cancer susceptibility, it appears that ... Read More

Drug companies eager to test type 2 diabetes drugs as weight loss treatments

bathroom scale

Manufacturers of some type 2 diabetes drugs are working on federal approval to expand their drug’s indication to include weight loss even in patients who do not have the chronic disease. When Novo Nordisk discovered that its type 2 diabetes drug Victoza had a side effect of weight loss, the company set out to test the drug at higher doses in clinical trials to see if it could trigger weight loss in both diabetics and non-diabetics. Data shows that the drug can melt up to 10 percent of body mass and, as a result, Novo Nordisk has filed for marketing ... Read More