FDA

FDA approves first biosimilar treatment

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The Food and Drug Administration approved its first biosimilar product in March, opening the door for more costly drug alternatives.

Off-label promotions of diabetes meds sometimes nonsensical, watchdog warns FDA

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The nation's leading consumer watchdog is asking the Food and Drug Administration to prohibit direct-to-consumer diabetes drug advertising promoting unapproved off-label benefits like weight and blood pressure reduction.

FDA approves 'breakthrough' therapy for diabetic eye disorder

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The FDA announced Wednesday that it has granted "breakthrough therapy designation" to the drug Eylea, and expanded its approved use for the treatment of diabetic retinopathy in patients with diabetic macular edema.

FDA panel approves first biosimilar drug

The Food and Drug Administration approved its first biosimilar product last week, opening the door for more costly drug alternatives.

Another state considers terminally ill access to experimental drugs

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Despite opposition from some drug makers and provider groups, Illinois lawmakers are considering several bills that would allow terminal patients to try unapproved experimental drugs to extend their lives.

Assisted living residents with dementia receiving too many antipsychotics, GAO says

Assisted living residents with dementia receiving too many antipsychotics, GAO says

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Government investigators are calling for greater scrutiny of antipsychotics use among dementia patients in post-acute settings beyond nursing homes.

Also in the news for Tuesday, February 17

Nursing home doctor pleads guilty, admits to $600,000 in kickbacks ... FDA releases compounding pharmacy draft documents ... House bill would repeal Health Insurance Tax

Also in the news for Wednesday, February 4

Beloved nursing home therapy dog shot in Kansas ... Food and Drug Administration is requesting a budget of $4.9 billion ... System for monitoring side effects of prescription drugs is severely lacking, report says.

FDA approves extended-release opioid painkiller

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The U.S. Food and Drug Administration gave market clearance to an extended-release opioid painkiller yesterday. It is designed for those with severe pain.

FDA approves XARELTO Starter Pack for DVT

FDA has approved the XARELTO Starter Pack™ for deep vein thrombosis or pulmonary embolism. The medication is use to reduce the risk of stroke or blood clots in those with atrial fibrillation not caused by a heart valve problem.

FDA approves weight management drug

The U.S. Food and Drug Administration has approved Contrave as a treatment for chronic weight management. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation.

Pharmacists object to further restrictions for hydrocodone combination products

Pharmacists object to further restrictions for hydrocodone combination products

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Hydrocodone combination products such as Vicodin will now be in the same, more-restrictive category as OxyContin and fentanyl under the Controlled Substances Act, the Drug Enforcement Administration announced Thursday.

Good news for (yawn) shift workers and residents

Good news for (yawn) shift workers and residents

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Long-term care professionals around the country cheered wildly last week when the Food and Drug Administration approved Belsomra, a new sleep drug. Shift workers applauded the addition to their medicine cabinets, already well-stocked with sleep aids. "I've tried melatonin and Ambien, but I didn't feel great on either one of those dr—" said certified nursing assistant Susie Sleepless, interrupted by a yawn.

Two medications are approved by FDA

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The U.S. Food and Drug Administration approved two medications in June that may benefit long-term care patients.

There's an app for that, but should there be?

There's an app for that, but should there be?

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Some apps - like those that are meant to track blood pressure or give medication reminders - are geared toward your future residents. And that's where the trouble can arise, according to a group of experts writing in the New England Journal of Medicine.

New hand hygiene guidelines urge healthcare facilities to avoid certain soaps

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Experts advise healthcare facilities to avoid a "heavily marketed" soap in updated hand hygiene guidelines published Wednesday.

Regen Synergistics introduces BodyRepairRX

Regen Synergistics introduces BodyRepairRX

Regen Synergistics has introduced the "Body RepairRX" nutritional supplement, designed to promote health and wellness.

FDA approves drug to treat MRSA skin infections

The Food and Drug Administration has approved Dalvance (dalbavancin), an antibacterial drug used to treat adults with bacterial skin and skin structure infections. Among them are infections caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.

FDA lowers starting dose for Lunesta

The Food and Drug Administration announced last week that the sleep drug Lunesta should be started at a lower dose.

FDA approves heart attack drug

The Food and Drug Administration approved Zontivity (vorapaxar) tablets last week. The medication is meant to reduce the risk of heart attack, stroke, cardiovascular death or a need to operate to restore blood flow for patients with a previous heart attack or blockages in the arteries.

Accessory for swimming approved for cochlear implants

Accessory for swimming approved for cochlear implants

The Food and Drug Administration has approved the Aqua+ accessory, a waterproof, behind-the-ear product for cochlear implant recipients. The accessory allows Cochlear™ Nucleus® 5 and Nucleus 6 Implant recipients2 to swim underwater for up to two hours, Cochlear Limited said.

Non-Invasive Open Ventilation System approved

Non-Invasive Open Ventilation System approved

Breathe Technologies, which makes the Non-Invasive Open Ventilation (NIOV) System, said the Food and Drug Administration has granted the fifth 510(k) clearance for the product.

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.

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