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FDA

A new oral anticoagulant hits the market

Pradaxa gives clinicians a new tool for preventing strokes and
blood clots in patients with atrial fibrillation. Learn how it works,
who’s eligible to receive it, and how to administer it.

Abbott withdraws Meridia from market

On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a…

Counterfeit surgical mesh

On March 11, the U.S. Food and Drug Administration issued a warning about counterfeit surgical mesh being distributed under C.…

Drug approval for breast cancer

The U.S. Food and Drug Administration has approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and…

Drugs Today – August 2008

Web Exclusive! An update of drug news, including alerts, approvals, and removals, at www.AmericanNurseToday.com/journal.

Drugs Today – November 2008

Web Exclusive! An update of drug news, including alerts, approvals, and removals at www.AmericanNurseToday.com/journal.

Drugs Today – Sept/Oct 2009

FDA warns against certain OTC nasal sprays Over-the-counter Zicam intranasal cold medications may cause long-term or permanent loss of the…

Ebola updates from FDA

The U.S. Food and Drug Administration (FDA) is working to help expedite the development and availability of medical product, such…

Engage Introducer recalled

On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the recall of 6 French Engage Introducers manufactured between…

Environment, health, & safety

With the growing reuse of single-use medical devices, ANA supports improvements in end-of-use product management and research on ethical and safety issues related to these devices.

FDA Advises to stop using Rotarix

On March 22, the U.S. Food and Drug Administration recommended a temporary suspension of the vaccine Rotarix although currently there…

FDA approves Afrezza

On June 27, the U.S. Food and Drug Administration (FDA) approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin…

FDA approves artificial heart valve

On June 17, the U.S. Food and Drug Administration (FDA) approved the SAPIEN 3 Transcatheter Heart Valve (THV) for patients…

FDA approves Brilinta for ACSs

The U.S. Food and Drug Administration (FDA) has approved Brilinta (ticarelor) for reducing cardiovascular death and heart attack in patients…

FDA approves CPR devices

On March 9 the U.S. Food and Drug Administration (FDA) approved the ResQCPR System, a system of two devices for…

FDA approves device to treat obesity

On January 14, the U.S. Food and Drug Administration (FDA) approved the Maestro Rechargeable System for certain obese adults, the…

FDA approves drug for rare lung disease

On May 28, the U.S. Food and Drug Administration (FDA) approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis, a rare, progressive lung…

FDA approves drug for scorpion sting

The U.S. Food and Drug Administration (FDA) had approved Anascorp, the first specific treatment for a scorpion sting by Centruroides…

FDA approves generic Abilify

On April 28, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole). Read more.

FDA approves head lice treatment

The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in…

FDA approves Levaquin for plague

On April 27, the U.S. Food and Drug Administration approved Levaquin (levofloxacin) to treat patients with plague. The drug was…

FDA approves losartan generic

On April 6, the U.S. Food and Drug Administration approved the first generic versions of two drugs used for the…

FDA approves new anticlotting drug

On January 8, the U.S. Food and Drug Administration (FDA) approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the…

FDA approves new cholesterol-lowing drug

On July 24, the U.S. Food and Drug Administration (FDA) approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in…

FDA approves new COPD treatment

On July 23, the U.S. Food and Drug Administration (FDA) approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment…

FDA approves new daily treatment for RLS

The U.S. Food and Drug Administration has approved Horizant Extended Release Tablets (gabapentin enacarbil) as a daily treatment for moderate-to-severe…

FDA approves new device for asthma

On April 27, the U.S. Food and Drug Administration approved the first medical device that uses radiofrequency energy to treat…

FDA approves new diabetes drug

On March 29, the U.S. Food and Drug Administration (FDA) approved Invokana (canagliflozin) tablets to treat adults with type 2…

FDA approves new drug for COPD

The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary…

FDA approves new drug for gout

On Dec. 22, the U.S. Food and Drug Administration (FDA) approved Zurampic (lesinurad) to treat high levels of uric acid…

FDA approves new drug for heart failure

On July 7, the U.S. Food and Drug Administration (FDA) approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure.…

FDA approves new drug for hyperkalemia

On Oct. 22, the U.S. Food and Drug Administration (FDA) approved eltassa (patiromer for oral suspension) to treat hyperkalemia. Read…

FDA approves new drug for lupus

The U.S. Food and Drug Administration has approved Benlysta (belimumab) for treatment of lupus. The FDA last approved a drug…

FDA approves new drug for osteoporosis

On June 1, the U.S. Food and Drug Administration (FDA) approved Prolia (denosumab), an injectable treatment for postmenopausal women with…

FDA approves new drug for PAH

On Dec. 22, the U.S. Food and Drug Administration (FDA) approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial…

FDA approves new drug for psoriasis

On January 21, the U.S. Food and Drug Administration (FDA) approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.…

FDA approves new drug for schizophrenia

The U.S. Food and Drug Administration has approved Latuda (lurasidone HCL) tables for the treatment of adults with schizophrenia. Read…

FDA approves new drug for thyroid cancer

On February 13, the U.S. Food and Drug Administration (FDA) approved Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid…
antibacterial drug fda urinary tract infection ant

FDA approves new drug for UTI

“The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, M.D., director of the…

FDA approves new drugs

·On Dec. 16, the U.S. Food and Drug Administration (FDA) approved Basaglar (insulin glargine injection), a long-acting human insulin analog…

FDA approves new drugs

· On Dec. 8, the U.S. Food and Drug Administration (FDA) approved: · Vonvendi, von Willebrand factor (Recombinant), for use…

FDA approves new drugs

On Nov. 24, the U.S. Food and Drug Administration (FDA) approved: Fluad, the first seasonal influenza vaccine containing an adjuvant…

FDA approves new drugs

· On Nov. 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Darzalex (daratumumab) to treat patients…

FDA approves new drugs

·On Sept. 22, the U.S. Food and Drug Administration (FDA) approved Lonsurf (a pill that combines two drugs, trifluridine and…

FDA approves new drugs for diabetes

On Sept. 25, the U.S. Food and Drug Administration (FDA) approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin…

FDA approves new hemophilia treatment

On June 6, the U.S. Food and Drug Administration (FDA) approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use…

FDA approves new melanoma drug

The U.S. Food and Drug Administration (FDA) has approved Zelboraf (vemurafenib) for use in patients with metastatic or unresectable melanoma…

FDA approves new MRI agent

The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of…

FDA approves new MS drug

On Sept. 12, the U.S. Food and Drug Administration (FDA) approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of…

FDA approves new weight-loss drug

On July 17, the U.S. Food and Drug Administration (FDA) approved Qsymia (phentermine and topiramate extended-release) as an addition to…

FDA approves Zykadia for NSCLC

On April 29, the U.S. Food and Drug Administration (FDA) approved Zykadia for patients with a certain type of late-stage…

FDA authorizes use of Ebola test

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize use of the LightMix®…

FDA changes blood donation policy

On Dec. 21, the U.S. Food and Drug Administration (FDA) changed its recommendation that men who have sex with men be…
neonatal mri system

FDA clears first neonatal MRI system

On July 20, the U.S. Food and Drug Administration (FDA) cleared Embrace Neonatal MRI System, the first magnetic resonance imaging…

FDA clears STERIS system

On April 5, the U.S. Food and Drug Administration cleared the STERIS System 1E Liquid Chemical Sterilant Processing System. The…

FDA grants waiver for flu test

On January 6, the U.S. Food and Drug Administration (FDA) granted the first waiver to allow a nucleic acid-based test,…

FDA halts Avandia trial enrollment

The U.S. Food and Drug Administration (FDA) notified GlaxoSmithKline that the post-marketing trial of Avandia (rosiglitazone) is on “partial clinical…

FDA launches drug shortages app

On March 4, the U.S. Food and Drug Administration (FDA) launched a free mobile app that identifies current drug shortages,…

FDA News

On April 30, McNeil Consumer Healthcare, in consulation with the U.S. Food and Drug Administration, issued a voluntary recall of…

FDA publishes REMS list

Access a list of Risk Evaluation and Mitigation Strategies (REMS) required by the U.S. Food and Drug Administration (FDA). Read…

FDA recalls Alere diagnostic tests

On July 11, the U.S. Food and Drug Administration (FDA) announced the recall Alere Triage’s rapid diagnostic test system, which…

FDA restricts patient access to rosiglitazone

The U.S. Food and Drug Administration (FDA) has added new restrictions on how rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl): Healthcare providers…

FDA teething tablet warning

On Jan. 27, the U.S. Food and Drug Administration (FDA) warned that homeopathic teething tablets containing belladonna pose an unnecessary…

FDA to strengthen review of AEDs

On January 28, the U.S. Food and Drug Administration (FDA) announced that it will strengthen its review of automated external…

FDA warns against Evital

The U.S. Food and Drug Administration (FDA) is warning consumers not to take the emergency birth control medicine labeled as…

FDA warns companies to stop MRSA claims

The U.S. Food and Drug Administration has issued four warning letters to companies selling over-the-counter drug products, including hand sanitizers,…

Hospira infusers recalled

On Sept. 10, the U.S. Food and Drug Administration announced the recall of the Hospira Symbiq One-Channel and Two-Channel Infusers…

How to revive the FDA

The Oct. 6 New England Journal of Medicine includes a perspective on how to “revive” the U.S. Food and Drug…

Influenza drug information from FDA

The U.S. Food and Drug Administration has a section on its website about influenza antiviral drugs at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm

Infusion pump resource from FDA

The U.S. Food and Drug Administration has devoted a section of its website to infusion pump safety. It includes a…

MedWatch marks 20-year anniversary

One June 3, the U.S. Food and Drug Administration (FDA) posted an article commemorating the 20th anniversary of MedWatch, which…

Metronidazole recall announced

The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot…

Obesity treatment devices resource

“Obesity Treatment Devices,” a section on the U.S. Food and Drug Administration (FDA) website, provides information on the only two…

Propoxyphene taken off market

Xanodyne Pharmaceuticals, Inc., which makes Darvon and Darvocet, the brand versions of the prescription pain medication propoxyphene, has agreed to…

Take Note

2/11/10 Three steps to lower childhood obesity Preschool children who do one or more of the following have a lower…
estrogen women woman note

Take Note – August 2007

Good news for younger women taking estrogen     Estrogen therapy may have cardioprotective effects for women who start taking it in…
ibuprofen medication meds pills pill

Take Note – December 2006

CDC recommends HIV screening for everyone New recommendations from the Centers for Disease Control and Prevention (CDC) call for routine…
cpr family friend note

Take Note – February 2007

Low-carb diets don’t affect cardiac risk Although diets low in carbohydrates and high in fats and proteins have been popular…
inhaler dry powder note mrsa dementia

Take Note – February 2008

Elizabeth Battaglino Cahill, RN, named executive director of National Women’s Health Resource Center The National Women’s Health Resource Center (NWHRC)…
type 2 diabetes

Take Note – July 2007

On-line video-based course on emergency preparedness   The need for better coordination between governmental agencies and hospitals became apparent after 9/11…
kid eating healthy child girl veggies vegetable

Take Note – July 2008

Measles outbreak       Between January 1 and April 25, the Centers for Disease Control and Prevention received reports of 64 measles…
breast feeding breastfeeding baby

Take Note – November 2006

American Diabetes Association releases food guidelines for specific medical categories “When you’re talking about diabetes, there is no ‘one size…

The Avandia saga

Read an interesting editorial about Avandia here. A U.S. Food and Drug Administration panel recommended keeping the drug on the…

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