Food and Drug Administration

Two medications are approved by FDA

By

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

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.

CMS loosens nursing home infection control guidance for single-use devices

By

Nursing homes now have new guidance about using certain types of reprocessed medical devices, the Centers for Medicare & Medicaid Services announced.

Supreme Court to hear case sparked by Omnicare deals

Supreme Court to hear case sparked by Omnicare deals

By

A recent $4 million legal settlement over kickbacks for anemia drug Aranesp is small change compared to other recent deals Omnicare has made with federal authorities. News of these payouts hasn't escaped long-term care pharmacy investors, some of whom filed their own charges against the pharmacy provider, launching a case that is now set to be heard by the U.S. Supreme Court.

FDA warning: Recalled rice product sold to nursing homes

By

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

FDA hands down guidance on mobile apps

By

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

Long-term care advocates denounce FDA over new hydrocodone restrictions

By

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 approves Clinolipid for intravenous feeding

The Food and Drug Administration on Friday approved a lipid injectable emulsion called Clinolipid for parenteral nutrition in adult patients.

Long-term statin use reduces dementia risk by 30%, researchers discover

By

Statins, which are commonly used to treat high cholesterol, do not cause cognition problems in the short term and may offer significant protection against dementia in the long term. This is according to new research that contradicts government warnings about these medications.

Insulin infusion sets recalled

By

Certain Medtronic MiniMed Paradigm Insulin Infusion sets are being recalled, the Food and Drug Administration announced on Friday.

Two asthma inhalers left gasping for life

By

Two asthma inhalers are being phased out, the Food and Drug Administration announced at the end of May.

FDA — full of poop?

FDA — full of poop?

By

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.

Fecal transplants to treat C. diff now need FDA approval

By

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 new oral drug to relieve constipation from opioid painkillers

By

Long-term care residents who experience constipation from taking opioids to manage chronic pain may benefit from Amitiza, an oral drug recently approved by the Food and Drug Administration.

Court upholds $142 million Neurontin verdict

Pfizer must pay $142 million for the marketing and prescribing of epilepsy drug Neurontin for unapproved uses, a federal appeals court has ruled.

Feds should tighten access to common painkillers, legislators say

The Food and Drug Administration should "act without delay" in tightening access to hydrocodone painkillers such as Vicodin, Congressional lawmakers urged in a recent letter. The letter was written by Sen. Joe Manchin (D-WV) and signed by a bipartisan group of five other senators and two representatives.

Becoming wide awake about the dangers of sleeping pills

Becoming wide awake about the dangers of sleeping pills

By

There are some people who are able to fall asleep as their head is hitting the pillow. Then there are the rest of us. And if you don't think you know any of us, you're probably wrong.

FDA orders recommended dosages of sleeping pills to be halved

The Food and Drug Administration is requiring manufacturers of certain sleeping pills, including the widely prescribed Ambien, to reduce current recommended dosages.

Invacare signs consent decree to correct wheelchair manufacturing problems

Invacare has signed a consent decree in which the company will fix wheelchair manufacturing problems, the Food and Drug Administration announced.

Unapproved marketing of pressure ulcer drug brings settlement worth up to $48 million

Unapproved marketing of pressure ulcer drug brings settlement worth up to $48 million

By

The unapproved bed sore drug Xenaderm, which was marketed to nursing homes as "Medicaid reimbursed," is the source of a settlement that could reach $48 million for Healthpoint Ltd. and DFB Pharmaceuticals.

GSK agrees to pay $90 million to settle diabetes drug allegations

By

GlaxoSmithKline will pay a $90 million settlement to 38 states that claimed it unlawfully promoted its diabetes treatment Avandia (rosiglitazone). The attorneys general of several states confirmed the action on Thursday.

Senator calls for an end to misleading wheelchair and scooter advertisements

By

The aggressive marketing of power wheelchairs and scooters to seniors drives up Medicare costs and puts providers in a tough spot, says Sen. Richard Blumenthal (D-CT).

FDA user fees legislation signed into law

President Obama signed the Food and Drug Administration user fees bill into law on Monday. The measure reauthorizes user fees paid by medical device and drug companies and creates new user fee programs for generic drugs and bio-similar (or follow-on biologic) drugs. In addition, the measure creates regulatory provisions affecting drugs and devices. These include antibiotic development incentives, shortage prevention provisions and new guidance for related social media activities.

FDA endorses safety measures for long-acting opioid painkillers

Companies that manufacture opioid painkillers must underwrite training and educational programs for the physicians who prescribe them, according to a new federal safety measures announced Monday.

Nursing home antipsychotic legislation set aside

Nursing home antipsychotic legislation set aside

By

The U.S. Senate did not approve legislation that would strengthen regulations for antipsychotic use in nursing homes, despite overwhelmingly passing a bill it was attached to on Thursday.

Drugs, the lottery and your company's future

Drugs, the lottery and your company's future

By

Having recently plunked down a $120 co-pay for medicine that was a far cry from designer caliber, I can relate to people who believe drugs are too expensive.

Higher dose of Alzheimer's drug approved despite FDA warnings, report shows

By

Makers of the Alzheimer's drug Aricept released a higher dosage version of the medication despite concerns about side effects and reduced efficacy, a study reports.

FDA warns of risk of anemia drugs

Medications given to treat anemia in kidney and cancer patients greatly increase the risk of cardiovascular problems and need to be used more conservatively, the Food and Drug Administration has said.

Study: Atypical psychotropics are not more dangerous than conventional antipsychotics

Atypical antipsychotic medications are no more dangerous than other conventional antipsychotics, antidepressants and benzodiazepines when it comes to treating nursing home residents, according to a new study.

Don't miss any McKnight's news