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Xarelto safety label updated to include details of major bleeds


The ADVERSE REACTIONS section of the safety label for the blood thinner Xarelto (rivaroxaban) has been updated to include more detailed information about bleeding risks. Xarelto, made by Bayer and Johnson & Johnson unit Janssen Pharmaceuticals, was first approved by the Food and Drug Administration (FDA) in 2011. It is used to prevent strokes in patients with an irregular heart rhythm called atrial fibrillation, to treat and prevent blood clots of the deep veins and lungs, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. Xarelto was designed to go head-to-head with the ... Read More

Alabama auto supplier fined after worker suffers accidental amputations


An Alabama automotive parts manufacturer will have to pay $103,000 in penalties after an investigation triggered by the amputation of a plant worker’s arm and fingers exposed a number of safety deficiencies that violate federal rules. Occupational Safety and Health Administration (OSHA) regulators inspected the Huntsville, Ala. plant of Matsu Alabama Inc., doing business as Matcor Automotive Inc., on Sept. 29 in response to a workplace accident that permanently disfigured a temporary worker. Matcor makes and supplies various auto parts to a number of automakers, including Fiat-Chrysler, General Motors, Honda, Nissan, and Toyota. According to OSHA, the worker was using ... Read More

Listeria-Contaminated Roquefort Cheese Prompts Whole Foods Recall

Recall - Whole Foods roquefort cheese, Papillon

Whole Foods is pulling a brand of organic Roquefort cheese from the shelves of its retail stores and issuing a nationwide recall after sample tests revealed the presence of Listeria Monocytogenes, a notoriously resilient and potentially deadly form of bacteria. The recall involves Papillion brand organic Roquefort cheese that is cut in store and packaged in clear plastic wrap with a Whole Foods scale label. The Austin, Texas-based natural food grocery chain said that customers can identify the affected cheese by the scale label, which has a PLU starting with 029536. Anyone who is uncertain about the manufacturer of Roquefort ... Read More

Erectile dysfunction drugs update safety label to include new contraindication


Drugs to treat erectile dysfunction have updated their safety labels to include an increased risk of low blood pressure when used in patients also taking pulmonary hypertension drugs known as guanylate cyclase (GC) stimulators, such as Riociguat. The new contraindication will be added to the safety labels of Cialis (tadalafil), Levitra and Staxyn (vardenafil), Stendra (avanafil), and Viagra (sildenafil citrate). The drugs are in a class of medications known as PDE5 inhibitors. The drugs help men get and maintain erections by relaxing the smooth muscles of the penis and increasing blood flow. They also work through the same genetic pathways ... Read More

Type 2 diabetes added to list of statin side effects


Cholesterol-lowering statin drugs are widely prescribed to lower levels of LDL – the so-called “bad” cholesterol – that builds up in the arteries in order to prevent cardiovascular events. However, studies have found the drugs can increase blood sugar levels and put users at risk of developing type 2 diabetes. Statins work by preventing the liver from producing LDL cholesterol. They also stabilize the lining of the blood vessels, which helps to prevent strokes and heart attacks. How statins effect glucose metabolism is unclear. Some studies suggest that statins may cause hyperglycemia – or high blood sugar – by increasing ... Read More

Watchdog Calls for Investigation Of Congress Members Benefiting From Payday Lending Industry

Payday loan shop window by Gregory F. Maxwell, Licensed under GFDL 1.2 via Commons

The watchdog organization Campaign for Accountability (CfA) has asked the Office of Congressional Ethics to investigate 11 members of Congress who allegedly accepted financial contributions from the payday lending industry just before, and in some cases right after, taking official actions that benefit the industry but harm the consumer. Payday lenders are notorious for predatory lending practices that take advantage of low-income individuals and families by charging extremely high interest rates on loans, then compounding the debt by rolling fees and higher interest for late payments into new loans, trapping millions of workers in a cycle of debt from which ... Read More

FDA orders duodenoscope makers to conduct studies on devices


The Food and Drug Administration (FDA) is ordering three manufacturers of specialized endoscopes called duodenoscopes, blamed for spreading drug resistant superbugs at several hospitals in the United States, to conduct studies to evaluate how the devices work and what can be done to stop the spread of more infections. Duodenoscopes are flexible tubes that are fed down a patient’s esophagus to treat or diagnose various gastrointestinal conditions. The surgical tools, considered key in illness detection and treatment, are used in about a half million procedures each year. The devices have small crevasses that researchers say can harbor bacteria. These spaces are difficult ... Read More

Talc linked to increased risk of lung diseases, ovarian cancer

baby powder contains talc

Manufacturers of talcum powder products have convinced consumers that their body and baby powders are safe even for infants. However, national health agencies, including the Food and Drug Administration (FDA) and the American Cancer Society, acknowledge there are safety concerns related to talc. Talc is a naturally occurring mineral that contains elements such as magnesium, silicon and oxygen. It can also contain asbestos, though many manufacturers claim that their talc-containing products do not contain detectable amounts of the carcinogen. Regardless, talcum powder has been linked to serious health problems including an inflammation in the lungs known as talcosis, mesothelioma, and ... Read More

New black box warnings added to HIV drugs


Abacavir, a type of drug used to slow the progression of the human immunodeficiency virus (HIV) infection carries updated black box warnings, the most serious warning issued by the Food and Drug Administration (FDA) reserved for drugs in which there is a reasonable probability that the medication can cause serious health consequences or death. One of the boxed warnings involves serious and sometimes hypersensitivity reactions with multiple organ involvement. The listing warns “NEVER restart (brand name drug) or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following ... Read More

Consider side effects with meds for autism-related irritability


Parents of children with autism are faced with tough decisions when considering antipsychotic medication to treat irritability. Weight gain is perhaps the most cited side effect associated with antipsychotics, but other adverse reactions should be taken into consideration as well. “It’s important to remember that if a medication is powerful enough to relieve symptoms, it is powerful enough to cause side effects,” said Dr. Christopher McDougle, director of Massachusetts General Hospital’s Lurie Center for Autism, a member of Autism Speaks Autism Treatment Network. “This is certainly true of the medications used to treat irritability and related behavioral challenges in individuals ... Read More