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FDA approves new pill for dialysis patients with warnings

dialysis

Keryx Biopharmaceuticals received Food and Drug Administration (FDA) clearance for its ferric citrate drug to treat complications with kidney disease, but the approval requires the drug company to add a warning to the safety label that using the drug can cause “iron overload,” which may require physician supervision while the patient is being treated. The drug is designed to treat dialysis patients with hyperphosphatemia, or elevated phosphates, which can lead to heart disease, bone density problems, and death. Keryx said that because ferric citrate can boost patients’ iron levels, dialysis patients who used anemia drugs and intravenous iron could reduce ... Read More

FDA approves new diet pill Contrave

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A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

Children can be prescribed statins as young as age 8

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Children with a genetic cholesterol disorder can lower their risk of developing cardiovascular disease by taking cholesterol-lowering statins, according to a long-term European study. The research involved 194 children and teenagers with an inherited high cholesterol disorder known as familial hypercholesterolemia, a condition that affects about one in 500 people. People with this condition are at risk for premature hardening of the arteries (atherosclerosis). The children and teens were prescribed a statin drug and were followed for 10 years. Statins include the widely prescribed brand name drug Lipitor. According to researchers, taking statins prevented premature atherosclerosis. The younger a child ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

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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

FDA panel recommends approving diabetes treatment for obese patients

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A Food and Drug Administration (FDA) advisory panel has given a thumbs-up recommendation to Novo Nordisk’s type 2 diabetes drug liraglutide for the treatment of chronic obesity in patients with at least one weight-related health issue, such as hypertension or pre-diabetes. Liraglutide, known commercially as Victoza, would be sold under the label Saxenda for the obesity indication if it is approved by the FDA. The agency is not required to follow the recommendations of its advisory panels, but it usually does. The positive recommendation was based on a clinical trial in which patients were given 3 mg of liraglutide. About ... Read More

Former NECC pharmacist arrested on criminal charges stemming from fungal meningitis outbreak

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A man was arrested last week as part of an ongoing investigation into the deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts. Glenn Adam Chin was attempting to board a plane to Hong Kong when federal authorities arrested him on one count of mail fraud. According to the Department of Justice, the maximum sentence under the statute is 20 years in prison followed by three years of supervised release and a $250,000 fine. The U.S. Attorney’s Office and the Civil Division’s Consumer Protection ... Read More

Hospira recalls heparin vials due to contamination with human hair

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Hospira, Inc., is recalling one lot of its blood thinner Heparin after confirming that a piece of human hair was found floating in a sealed vial. The nationwide user-level recall involves one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL) in 0.9 percent Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. The injection of particulate material, such as human hair, may cause local inflammation, phlebitis, and/or low-level allergic response. Capillaries, which may be as small as the size of a red blood cell, approximately seven microns in diameter, ... Read More

FDIC Offers Tips for those Struggling in the Surge of Data Breaches

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The recent flood of data breaches affecting stores such as Target and Home Depot has taken its toll on the financial security of shoppers. Unfortunately, consumers are simply unable to predict when and where a data breach might occur. However, the Federal Deposit Insurance Corporation (FDIC) recommends taking the following steps to prevent fraudulent activity from affecting your bank account. *  Always check your credit card and bank statements for questionable transactions. A thorough review of your most recent transactions can be the best security for fraudulent activity. If you have any questions or concerns about a transaction you have ... Read More

Rubber tubes sold at Walmart recalled after causing skin irritation

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This week, 20,500 inflatable rubber tubes sold at Walmart have been recalled due to numerous reports of skin irritation upon contact with the tubes. The tubes, made by Coleman, are black Sevylor brand River Racer inflatable rubber tubes. The recalled rubber tubes measure 36 inches in diameter and are about 15 inches tall, seating one person per tube. The Sevylor logo and River Racer logo can be seen on the outer side, printed in blue. The model number of the recalled tubes (2000014090) can be found on the inner side of the tube below the bottom left corner of the English ... Read More

Whistleblower lawsuit targets medical companies, professionals for unnecessary spinal surgeries

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The U.S. government has intervened in a whistleblower’s False Claims Act lawsuit against a Michigan neurosurgeon, a spinal implant company, two distributors, and the companies’ owners, alleging that the defendants conspired to perform medically unnecessary and excessive surgeries on patients for profit. The Justice Department also said that in addition to taking over the whistleblower lawsuit, it has filed a separate complaint against the same defendants for engaging in an illegal kickback scheme that put profits above patients’ needs. The whistleblower lawsuit was filed under the qui tam provisions of the False Claims Act by Dr. Caty Savitch and Dr. ... Read More