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…

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 request from the U.S. Food and Drug Administration.…

Counterfeit surgical mesh

On March 11, the U.S. Food and Drug Administration issued a warning about counterfeit surgical mesh being distributed under C. R. Bard/Davol brand name. Affected lot numbers are…

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 HER2-positive advanced breast cancer in postmenopausal women for…

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 sense of smell and should not be used,…

Drugs Today – September 2008

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

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 as treatments, vaccines, diagnostic tests, and personal protective…

Engage Introducer recalled

On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the recall of 6 French Engage Introducers manufactured between April 27 and June 3, 2010. Read more…

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 women with breast impants

The U.S. Food and Drug Administration says women with breast implants may have a “very small, but increased risk” of developing anaplastic large cell lymphoma (ALC). The FDA…

FDA allows marketing of consumer genetic tests

On April 6, the U.S. Food and Drug Administration (FDA) announced it was allowing marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases…

FDA allows marketing of military dressing

On April 3, the U.S. Food and Drug Administration (FDA) announced it is allowing marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types…
FDA announces new plan to address nicotine consumption

FDA announces new plan to address nicotine consumption

Protecting American Families: Comprehensive Approach to Nicotine and Tobacco Remarks by Scott Gottlieb, M.D. / Commissioner of Food and Drug Administration July 28, 2017 / White Oak, MD Tobacco use…

FDA announces recall of Stryker cutting guide for TKA

On April 19, the U.S. Food and Drug Administration (FDA) announced that Stryker Orthopaedics has recalled ShapeMatch Cutting Guides, used in total knee arthroplasty (TKA) instrumentation. Read more.
gene therapy fda approve ant

FDA approved first gene therapy in U.S.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D.…

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 to improve glycemic control in adults with diabetes…

FDA approves antiplatelet drug for use during PCI

On June 22, the U.S. Food and Drug Administration (FDA) approved Kengreal (cangrelor), an I.V. antiplatelet drug, for use in adults undergoing undergoing percutaneous coronary intervention (PCI). Read…

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 with aortic valve stenosis. Read more.

FDA approves Boostrix for older people

The U.S. Food and Drug Administration (FDA) has approved the Boostrix vaccine to prevent tetanus, diphtheria, and pertussis in people 65 years and older. Read more.

FDA approves contrast agent for CNS MRI scans

The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system. Read…

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 first responders to use while performing cardiopulmonary resuscitation…

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 first weight loss treatment device that targets 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 disease that primarily affects women of childbearing age.…

FDA approves drug for rare metabolic disorder

On Sept. 4, the U.S. Food and Drug Administration (FDA) approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria, a rare metabolic disorder…

FDA approves drug to reduce risk of preterm birth

The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant women with a history of at…

FDA approves drug to treat multi-drug resistant TB

On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB)…

FDA approves expanded use of Prevnar vaccine

The U.S. Food and Drug Administration (FDA) has approved the use of Prevnar 13, a pneumococcal 13-valent conjugate vaccine, in people 50 years and older. Read More.

FDA approves first drug for myelofibrosis

The U.S. Food and Drug Administration has approved Jakafi (ruxolitinb), the first drug approved to treat patients with the bone marrow disease myelofibrosis. Read more.

FDA approves first drug for tardive dyskinesia

On April 11, the U.S. Food and Drug Administration (FDA) approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. It’s the first drug approved by the FDA…

FDA approves first generic version of Nexium

On January 26, the U.S. Food and Drug Administration (FDA) approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in…

FDA approves Gazyva for chronic lymphocytic leukemia

On Nov. 1, the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.…

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 patients 4 years and older. Read more at…

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 approved under the agency’s Animal Efficacy Rule, which…

FDA approves Lucentis to treat diabetic retinopathy

On February 6, the U.S. Food and Drug Administration (FDA) expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy in patients with diabetic…

FDA approves Marqibo for rare type of leukemia

On Aug. 9, the U.S. Food and Drug Administration (FDA) approved Marqibo (vincristine sulfate liposome injection) to treat adults with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).…

FDA approves medical device for epilepsy

The U.S. Food and Drug Administration (FDA) has approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.…

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 risk of stroke and dangerous blood clots (systemic…

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 a new class of drugs known as proprotein…

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 of bronchospasm in patients with chronic obstructive pulmonary…

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 restless legs syndrome (RLS). Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250188.htm.

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 severe and persistent asthma in adults. The Alair…

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 diabetes. Invokana has been studied as a stand-alone…
mylotrag treatment acute myeloid leukemia

FDA approves new drug for acute myeloid leukemia

On Sept. 1, the U.S. Food and Drug Administration (FDA) approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express…

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 disease (COPD). Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htm

FDA approves new drug for cystic fibrosis

On July 2, the U.S. Food and Drug Administration (FDA) approved Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) for the treatment of cystic fibrosis (CF) in patients 12 years…

FDA approves new drug for Gaucher disease

On August 19, the U.S. Food and Drug Administration (FDA) approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease,…

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 in the blood (hyperuricemia) associated with gout, when…

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 more.

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 for lupus in 1955. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm.

FDA approves new drug for metastatic lung cancer

On Oct. 9, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) to treat patients with metastatic non-small cell lung cancer whose disease progressed during or after…

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 osteoporosis who are at high risk of fractures.…

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 hypertension (PAH). Read more.

FDA approves new drug for pancreatic cancer

On Oct. 22, the U.S. Food and Drug Administration (FDA) approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer…

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. Read more.

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 more here.

FDA approves new drug for serious skin infections

On June 20, the U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) to treat patients with acute bacterial skin and skin structure infections caused by certain…

FDA approves new drug for severe asthma

On Nov. 4, the U.S. Food and Drug Administration (FDA) approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients…

FDA approves new drug for severe drooling

On July 28, the U.S. Food and Drug Administration (FDA) approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3…

FDA approves new drug for skin infections

On August 6, the U.S. Food and Drug Administration (FDA) approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections. Read more.

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 cancer whose disease progressed despite receiving radioactive iodine…

FDA approves new drug for type 2 diabetes

On August 1, the U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with…
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 Office of Antimicrobial Products in the FDA’s Center…

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 to improve glycemic control in adult and pediatric…

FDA approves new drugs

· On Dec. 8, the U.S. Food and Drug Administration (FDA) approved: · Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older…

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 Portrazza (necitumumab) in combination with two forms of…

FDA approves new drugs

· On Nov. 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least…

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 tipiracil) for patients with advanced colorectal cancer who…

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 aspart injection) to improve glucose control in adults…

FDA approves new implantable hearing device

On March 20, the U.S. Food and Drug Administration (FDA) approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of…

FDA approves new implanted hearing system

On March 17, the U.S. Food and Drug Administration announced the approval of the Esteem, an implanted hearing system for moderate to severe sensorineural hearing loss. Read the…

FDA approves new indication for imaging agent

On June 13, the U.S. Food and Drug Administration (FDA) a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help determine…

FDA approves new labeling for Embeda ER capsules

On Oct. 17, the U.S. Food and Drug Administration (FDA) approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat…

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 who have the BRAF V600E mutation. Read more.

FDA approves new melanoma treatments

On Oct. 28, the U.S. Food and Drug Administration (FDA) expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with…

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 the brain, spine and associated tissues of patients…

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 adults with relapsing forms of multiple sclerosis (MS).…

FDA approves new multiple sclerosis drug

On March 27, the U.S. Food and Drug Administration (FDA) approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis. Read more.

FDA approves new silicone breast implant

On Feb. 20, 2013, the U.S. Food and Drug Administration (FDA) approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant for augmentation in women at…

FDA approves new test for diagnosing gastroparesis.

On April 6, the U.S. Food and Drug Administration (FDA) approved Gastric Emptying Breath Test (GEBT), a new noninvasive test to help diagnose gastroparesis (delayed gastric emptying). Read…

FDA approves new treatment for advanced melanoma

On Nov. 10, the U.S. Food and Drug Administration (FDA) approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to…

FDA approves new treatment for metastatic melanoma

The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.

FDA approves new treatment for multiple myeloma

On Nov. 30, the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received…

FDA approves new type of drug for insomnia

On August 13, the U.S. Food and Drug Administration (FDA) approved Belsomra (suvorexant) tablets for treating insomnia. Belsomra is the first approved orexin receptor antagonist. Read more

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 a reduced-calorie diet and exercise for chronic weight…

FDA approves Perjeta for late-stage breast cancer

On June 8, the U.S. Food and Drug Administration (FDA) approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage breast cancer. Read more.

FDA approves Pomalyst for advanced multiple myeloma

On Feb. 8, 2013, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease has progressed after being treated with…

FDA approves Simponi for ulcerative colitis

May 15, the U.S. Food and Drug Administration (FDA) approved a new use for Simponi (golimumab) injection: to treat adults with moderate to severe ulcerative colitis. Read more.

FDA approves Synribo for chronic myelogenous leukemia

On Oct. 26, the U.S. Food and Drug Administration (FDA) approved Synribo (omacetaxine mepesuccinate) for the treatment of adults with chronic myelogenous leukemia. Synribo blocks certain proteins that…

FDA approves Tanzeum to treat type 2 diabetes

On April 3, the U.S. Food and Drug Administration (FDA) approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type…

FDA approves test to distinguish between MRSA and MSSA

The U.S. Food and Drug Administration (FDA) has cleared the first test that can quickly distinguish between methicillin resistant Staphylococcus aureus (MRSA) and methicillin susceptible Staphylococcus aureus (MSSA).…

FDA approves tissue adhesive for internal use

On February 4, the U.S. Food and Drug Administration (FDA) approved TissuGlu, the first tissue adhesive approved for internal use. TissuGlu is a urethane-based adhesive that a surgeon…

FDA approves treatment for hereditary angioedema

The U.S. Food and Drug Administration (FDA) has approved Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema in people ages 18 years and older.…

FDA approves treatment of non-small cell lung cancer

The U.S. Food and Drug Administration (FDA) has approved Xalkori (crizotinib) to treat patients with late-stage non-small cell lung cancers who express the abnormal anaplastic lymphoma kinase (ALK)…

FDA approves two drugs for idiopathic pulmonary fibrosis

On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm and Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis. Read more about nintedanib…

FDA approves vaccine for meningococcal disease

On Oct. 29, the U.S. Food and Drug Administration (FDA) approved Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria…

FDA approves Xeljanz for rheumatoid arthritis

On Nov. 6, the U.S. Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate…

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 non-small cell lung cancer (NSCLC). Read more.

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® Ebola Zaire rRT-PCR Test for the presumptive detection…

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 indefinitely deferred from donating blood; the new time…
duodenoscope distal cap

FDA clears duodenoscope with disposable distal cap

On Sept. 20, the U.S. Food and Drug Administration (FDA) cleared Pentax ED34-i10T, the first duodenoscope with a disposable distal cap, which will improve access for cleaning and…
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 (MRI) device specifically for neonatal brain and head…
fda robotic surgery device

FDA clears new robotically-assisted surgical device

On Oct. 13, the U.S. Food and Drug Administration (FDA) cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery.  (more…)
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FDA clears patient-assisted mammography system

On Sept. 1, the U.S. Food and Drug Administration (FDA) cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression…

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 device is used to process reusable heat-sensitive devices…

FDA expands Zytiga’s use for late-stage breast cancer

On Dec. 10, the U.S. Food and Drug Administration expanded the approved use of Zytiga (abiraterone acetate) to treat men with metastatic castration-resistant prostate cancer before receiving chemotherapy.…

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, the Alere i Influenza A & B 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 hold,” meaning no new patients can be enrolled…

FDA issues alert for facial soft tissue fillers

On May 28, the U.S. Food and Drug Administration (FDA) issued an alert about the possibility of rare, but serious, injuries that may occur from unintentional injection of…

FDA issues safety communication for HeartStart AEDs

On Nov. 25, the U.S. Food and Drug Administration (FDA) issued a safety communication stating that certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems,…

FDA launches campaign to reduce youth smoking

On Oct. 7, the U.S. Food and Drug Administration (FDA) announced the launch of a national public education campaign to prevent and reduce tobacco use among multicultural youth…

FDA launches campaign to stop youth tobacco use

On Feb. 4, the U.S. Food and Drug Administration (FDA) announced the launch of a national public education campaign, called “The Real Cost”, to prevent youth tobacco use…

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, resolved shortages, and discontinuations of drug products. Read…

FDA looks to improve medical device review process

The U.S. Food and Drug Administration plans to implement changes in 2011 designed to improve review of medical devices. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm.

FDA marks 50 years of Kefauver-Harris amendment

This year the U.S. Food and Drug Administration (FDA) is marking the anniversary of the Kefauver-Harris amendment, passed 50 years ago. The legislation gave FDA weight to require…

FDA orders recall of Baxter infusion pumps

On May 3, the U.S. Food and Drug Administration (FDA) announced that it has ordered Baxter Healthcare Corp. to recall and destroy all of its Colleague Volumetric Infusion…

FDA permits marketing of dengue fever test

The U.S. Food and Drug Administration is allowing marketing of the first test to help diagnose people with signs and symptoms of dengue fever. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250584.htm.

FDA proposes new policy for some devices

The U.S. Food and Drug Administration (FDA) has proposed a new policy that reduces  premarket notification requirements related to devices that have had their safety and efficacy well…

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 more..

FDA releases draft guideline related to nanotechnology

The Food and Drug Administration (FDA) has released “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” a draft guidance document available for comment. The goal is…

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 must enroll in a special program in order…
United States Food and Drug

FDA taking new steps to address opioid addiction

On June 13, the U.S. Food and Drug Administration (FDA) announce new steps it is taking to address opioid addiction. Opioid formulations with properties designed to deter abuse…

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 risk to infants and children and urges consumers…

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 defibrillators (AEDs) to help improve the quality and…

FDA warning for terbutaline in preterm labor

The U.S. Food and Drug Administration issued a warning that terbutaline, indicated for asthma, bronchitis, and emphysema, should not be used in pregnant women for prevention or prolonged…

FDA warns against counterfeit Adderall

On May 29, the U.S. Food and Drug Administration (FDA) warned consumers and healthcare professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that…

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 Evital, which may not be safe or effective…

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, telling them to stop making claims that the…

Free online course on FDA drug regulation

Access “The Past, Present, and Future of FDA Human Drug Regulation,” a free educational program from the U.S. Food and Drug Administration is available here.

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 because of the potential of the device to…

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 Administration. Read it here.

Infections associated with reprocessed duodenoscopes

The U.S. Food and Drug Administration (FDA) has taken several steps in response to infections associated with reprocessed duodenoscopes, including issuing a safety communication that warned it is…

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 link for reporting an infusion pump problem. Read…

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 collects and reviews reports form healthcare professionals and…

Metronidazole recall announced

The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012 because “underweight” tablets may…

New boxed warning for propylthiouracil

On April 21, the U.S. Food and Drug Administration announced the addition of a boxed warning to the label for propylthiouracil. The warning includes reports of severe liver…

New lupus drug one step closer to approval

An advisory panel has recommended the U.S. Food and Drug Administration approve Benlysta; it would be the first new drug approved to treat Lupus in over 50 years.…

New newborn screening for metabolic disorders

On Feb. 3, the U.S. Food and Drug Administration (FDA) permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders in newborns. Read…

New safety information for Invirase

The U.S. Food and Drug Administration announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir). The warning describes potentially…

Ozone-depleting inhalers to be phased out

On April 13, the U.S. Food and Drug Administration announced that seven metered-dose inhalers used for asthma and chronic obstructive pulmonary disease will gradually be removed from the…

Pleural and Pneumopericardial Drainage Sets recalled

On Jan. 11, the Food and Drug Administration posted that Stryker Sustainability Solutions recalled its Pleural and Pneumopericardial Drainage Sets because the company received two reports hat the…

Preventing feeding tube misconnections

The U.S. Food and Drug Administration (FDA) has a website dedicated to the issue of tubing and Luer misconnections. The website includes a special section on prevention. Read…
medication errors

Preventing medication errors by empowering patients

Preventable medication errors cost the U.S. healthcare system more than $21 billion annually, according to the National Priorities Partnership and National Quality Forum. This number has risen significantly…

Propoxyphene taken off market

Xanodyne Pharmaceuticals, Inc., which makes Darvon and Darvocet, the brand versions of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at…

Single-dose IV Zofran pulled from market

On Dec. 4, the U.S. Food and Drug Administration announced that the 32 mg, single IV dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be…

Some fentanyl transdermal patches recalled

The U.S. Food and Drug Administration announced that Actavis Inc. has recalled 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches from wholesale and retail locations after…

Stay informed of recalls through MedWatch

To keep current on recalls announced by the U.S. Food and Drug Administration, sign up for one of several options through the agency’s MedWatch program. You can join…

Take Note

2/11/10 Three steps to lower childhood obesity Preschool children who do one or more of the following have a lower risk for obesity, according to a study of…
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 their 50s. A study from the Women’s Health…
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 human immunodeficiency virus (HIV) screening for all patients…
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 for the last few years, some experts have…
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) has appointed Elizabeth Battaglino Cahill as its executive…
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 and again after Hurricane Katrina. To fill this…
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 cases in nine states—the highest number for the…
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 fits all’ diet,” said Ann Albright, PhD, RD,…

The Avandia saga

Read an interesting editorial about Avandia here. A U.S. Food and Drug Administration panel recommended keeping the drug on the market, but increasing warnings about the drug’s potential…
unique device identifier nursing

The unique device identifier and nursing

What you need to know for reporting and patient safety TO PROMOTE patient health and safety, nurses need to learn about and incorporate activities related to medical devices’…

USDA new safety requirements for beta-agonists

The U.S. Food and Drug Administration has new safety requirements for long-acting beta-agonists used to treat asthma. Read the requirements at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm.,/p>

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