March 5, 2010

INSULIN PUMP PROBLEMS CONTINUE TO PLAGUE DIABETICS

According to The Wall Street Journal, the FDA is becoming increasingly concerned about the continuing and increasing number of hardware and software problems associated with insulin pumps, small devices worn by many diabetics to continuously deliver insulin, as an alternative to shots. Incredibly, over the last five years, there have been 18 recalls of insulin pumps, including recalls by manufacturers Johnson & Johnson, Medtronic, Inc., and Roche Holding AG. Tomorrow, the FDA is convening an advisory panel of experts to discuss what needs to be done to “minimize risks associated with the devices in these situations."

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February 26, 2010

OFF-LABEL PROMOTION CONTINUES TO MAKE NEWS

Last week, Novartis agreed to settle criminal allegations involving Trileptal, an anti-epilepsy drug, as it deals with similar investigations involving five other Novartis drugs: Diovan, Exforge, Zelnorm, Keturna and Sandostatin. Novartis has agreed to plead guilty to violations of the U.S. Food, Drug, & Cosmetic Act and pay a fine of $185 million. The settlement is pending court approval.

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February 26, 2010

HOSPITAL-ACQUIRED INFECTIONS STILL A HUGE THREAT TO PATIENTS

Perhaps the most troubling part of a recent study published yesterday in the Archives of Internal Medicine, which estimates that 48,000 people died in 2006 after developing deadly infections while in the hospital, was that many of the deaths involved healthy people who had minor procedures. Sepsis and pneumonia were the two most prevalent infections, accounting for one-third of the 1.7 million that American patients pick up every year while in the hospital, but the figure may be even higher according to the Study. And while certainly many hospital-acquired infections are unavoidable, many of the infections occur because of a lack of proper infection control. This is a serious and growing problem that some hospitals have addressed but many have not.

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February 22, 2010

Step Therapy – Health Care Cost Effectiveness at What Cost

In an attempt to drive down health care costs, insurance companies are utilizing what is commonly called "Step Therapy". Step Therapy, also called Step Protocol, forces patients to try the least expensive drug for a particular condition first to see if it is effective. If that drug is not effective, then the insurer will approve payment for the next least expensive drug and so on. From allergy and heartburn medications, to blood pressure medications, to medications for pain, New Jersey doctors and patients continue to be denied and denied again when it comes to Step Therapy.

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February 19, 2010

More illegal off-label marketing? Fentora now under investigation

The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?

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February 13, 2010

Surgeons have an Ethical Duty to Warn of Risks with Shoulder Pain Pumps

Dr. Joseph Carrese, director of the ethics and clinical practice program at John Hopkins Berman Institute of Bio-Ethics, recently stated that he believes surgeons need to inform all of their patients about the risks associated with the use of a pain pump catheter during shoulder surgery. Presently, many arthroscopic shoulder surgeries utilize this tiny catheter, placed directly into the shoulder joint, which infuses pain medication continuously for several days following the procedure. The concern that Dr. Joseph Carrese and many others have, is what happens to patients in the long run, as the result of this device.

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January 26, 2010

Graco Stroller Recall

On Wednesday, January 20, 2010, Newell Rubbermaid announced that it is recalling 1.5 million baby strollers after receiving 7 reports of amputations or lacerations to children’s' fingers. The products' canopy hinges are to blame for the injuries, which occurred when children got their fingers stuck in the canopy as it was being opened or closed.

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January 26, 2010

Meridia Causing Heart Problems?

Last week, the Food and Drug Administration (FDA) requested that drug manufacturer Abbott Laboratories strengthen the product labeling for its weight-loss drug Meridia (sibutramine) to disclose an increased risk of heart attack and stroke in patients with a history of cardiovascular disease.

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January 19, 2010

Tylenol Recall by Johnson & Johnson

Last week, drug manufacturer Johnson & Johnson announced an expansive recall of a variety of products, including Tylenol, Motrin, and Benadryl, after complaints of an “unusual moldy, musty or mildew-like” odor accompanying the products.

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December 16, 2009

CT Scan Radiation Causing Cancer

In October, we alerted readers that the FDA became aware of numerous radiation overexposures during CT scans at a particular facility, with patients receiving radiation doses that were approximately eight times the expected level. The article noted that this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility - putting patients at increased risk for long-term radiation effects.

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November 6, 2009

New Safety Warnings About Diabetes Drug and Kidney Functions

Recently, the safety warnings were strengthened for the diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease. Specifically, the US Food and Drug Administration ("FDA") notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

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October 21, 2009

Video and Audio Cables: Are Consumers Paying More than Necessary?

Consumers have paid upwards of $100 for cables whose performance is equal to a standard $10 six-foot HDMI cable. Many electronic stores and manufacturers have made claims that these “premium” cables outperform standard cables. However, many well respected third party reviewers, such as cnet.com contend that this isn’t necessarily the case. “Do you really need to spend that much money on a single HDMI cable? Absolutely not – those cables are a rip-off” says CNET. “And despite what salesman and manufacturers might tell you, there’s no meaningful difference between the $10 cable and the $50 cable.”

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