FDA

FDA warning: Recalled rice product sold to nursing homes

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Nursing homes should ensure they are not serving potentially hazardous Uncle Ben's brand rice products, the Food and Drug Administration has announced.

Glucose meters views sought

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Federal authorities are accepting comments through the first week of April on newly proposed stricter guidelines for blood glucose monitoring systems.

What's your load? How nurses can lighten med usage

What's your load? How nurses can lighten med usage

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The US Food and Drug Administration recently requested that practitioners stop prescribing combination prescription pain medications that have more than 325 mg of acetaminophen per tablet, capsule, etc., due to the risk of liver damage. This is a good thing.

FDA proposes glucose meter guidance to improve infection control in nursing homes, hospitals

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The U.S. Food and Drug Administration has drafted more stringent guidelines for blood glucose monitoring test systems used in nursing homes, hospitals and other healthcare settings.

FDA updates bed rail entrapment guidelines

FDA updates bed rail entrapment guidelines

Last month, the FDA posted some new materials on bed rails and related products. This reiterated what should by now be the well-known hazards of entrapment and death when the bed user gets entangled within openings of the rail, or between the rail and the mattress or part of the bed frame.

Blinking lights and deadly bacteria

Blinking lights and deadly bacteria

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Well, alrighty then. Looks like I didn't win the lottery. So I guess I'll have to buckle down and write yet another profound but cheeky blog post for this fine long-term care news magazine. Sure, I'm surprised. I felt really good about my chances. But I grew up in a church whose pioneers believed we'd all be taken to heaven on Oct. 22, 1844, so I'm used to Great Disappointment.

FDA takes closer look at antibacterial products

It may be time to put away the antibacterial hand soap and body wash at home and the office. The Food and Drug Administration said Monday manufacturers of antibacterial products will have to prove the items are more effective than plain soap and water

FDA hands down guidance on mobile apps

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The Food and Drug Administration has issued final guidance on mobile medical apps.

FDA approves first vaccine for prevention of H5N1 avian influenza

The Food and Drug Administration has approved the first vaccine for the prevention of H5N1 influenza, which is commonly known as bird flu.

FDA approves second brain imaging drug for Alzheimer's patients

Vizamyl, a radioactive diagnostic drug, was approved by the Food and Drug Administration on Friday. The drug, also known as flutemetamol F 18 injection, is used with positron emission tomography imaging for adults being evaluation for Alzheimer's disease and dementia.

Long-term care advocates denounce FDA over new hydrocodone restrictions

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The U.S. Food and Drug Administration has announced it will seek restricted access to hydrocodone painkillers, prompting a concerned response from long-term care stakeholders.

FDA clears the air on health benefits linked to chambers

FDA clears the air on health benefits linked to chambers

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Hyperbaric oxygen chambers can be used to treat diabetic foot ulcers, and the government is fine with that. But regulators are becoming increasingly concerned about other benefits that are being ascribed to these devices.

Care Innovations' product now FDA-cleared for home

Care Innovations' product now FDA-cleared for home

Care Innovations™ Connect RCM (Remote Clinical Management) is now FDA-cleared for use in a home care setting, the company said.

Reusable sharps container gets FDA approval

Reusable sharps container gets FDA approval

Rehrig Healthcare announced its SharpsTank® Reusable Sharps Container Model TS received Food and Drug Administration approval to market the device as an FDA 510(k) cleared Class II medical device.

FDA responds to provider pressure, backs off stricter control of fecal transplants for C. diff

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Individuals with treatment-resistant Clostridium difficile can undergo fecal transplants after giving informed consent, the Food and Drug Administration recently announced. This is a victory for providers, who pushed back after the FDA recently announced it would tighten regulations around the transplants.

FDA wants to fast-track treatments for C. diff

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Clostridium difficile poses a serious public health threat and potential treatments should be fast-tracked, the Food and Drug Administration stated in a newly proposed regulation.

FDA panel gives diabetes drug Avandia a limited victory

A Food and Drug Administration advisory panel has voted to ease measures that limit patient access to the diabetes pill Avandia.

FDA — full of poop?

FDA — full of poop?

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Every few days I read the Food and Drug Administration (FDA) news to see if there is anything relevant to eldercare that I should be aware of. Recently, I came across an extremely eye-opening item.

Avandia gets FDA win, but is unlikely to dominate market again

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A Food and Drug Administration advisory panel has voted to ease measures that limit patient access to the diabetes pill Avandia. Many panelists, however, said precautions are still needed.

FDA alerts providers to lack of sterility in NuVision Pharmacy products

The Food and Drug Administration expanded an alert about NuVision Pharmacy of Dallas, TX, on Saturday. It said investigators found poor sterile production practices that raised concern about a lack of sterility assurance for the company's sterile drug products.

Fecal transplants to treat C. diff now need FDA approval

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The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.

FDA approves highly anticipated COPD medication

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The Food and Drug Administration has officially approved Breo Ellipta, a much-anticipated new treatment for chronic obstructive pulmonary disease.

Seroquel generics okay, appeals court says

AstraZeneca is not entitled to more exclusivity with its antischizophrenic medication, an appeals court agreed last week. The company had claimed its drug, Seroquel, deserved another three-year extension under the Food Drug and Cosmetic Act.

FDA warns of germ-laden mattress covers

The Food and Drug Administration has warned nurses, infection control staff and other caregivers to examine their medical bed mattress covers. Damaged or worn covers can allow blood and body fluids to penetrate the mattress, causing an infection risk. Mattresses can be alternating pressure, non-powered flotation mattresses, or mattresses that are part of hospital beds.

Granny caught in the cross-fire again

Granny caught in the cross-fire again

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Once again the war on drugs catches frail elder patients in the crosshairs. Basically a "drive by" that shouldn't happen.

New kind of diabetes drug gets OK

New kind of diabetes drug gets OK

The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels. Invokana prevents the kidney from reabsorbing glucose, according to the FDA.

FDA approves new kind of oral diabetes drug

The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels. Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

FDA approves new kind of oral diabetes drug

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The Food and Drug Administration recently approved a new kind of type 2 diabetes drug to help better control glucose levels.

Diabetes drugs under scrutiny

Diabetes drugs under scrutiny

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Diabetes medications Januvia and Byetta significantly increase the risk of pancreatic inflammation, according to Johns Hopkins University School of Medicine researchers.

Half a dose of reality

Half a dose of reality

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We insomniacs know sleep is important. We've read all the studies, usually late at night when we can't sleep. We're very aware that insomnia is shortening our lives, and that our knowledge of that fact is worsening our insomnia.

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