FDA Updates for Health Professionals

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PRODUCT SAFETY

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For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

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Medical Product Safety  

Recall: Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira - Visible Particulates 

Hospira, Inc. will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to embedded particulate within the glass vial and visible particles floating in the solution. More information 

Class I Recall: Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc - May Not Properly Delay an Infusion

CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the “Delay For” Option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions. More information

Recall: Ventlab Resuscitator Bags - Possible Health Risk

Ventlab, LLC. initiated a voluntary medical device removal of certain Ventlab Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation. More information

MedWatch April 2014 Safety Labeling Changes 

This posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The "Summary Page" provides a listing of product names and safety labeling sections revised. More information

Drug Safety Communication: Eszopiclone Containing Sleep Aids - Can Cause Next-Day Impairment

FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. More information

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Drug Safety Communication: Pradaxa (dabigatran) - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs. More information 

 

Recall: Dobutamine Injection (250mg/20mL)/Hospira - Visible Particulates

 

Hospira, Inc. issued a nationwide recall to the user level for one lot of Dobutamine Injection, USP, 250 mg, 20 mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. (NDC and lot number can be found on the right-hand side of the primary label). More information

Recall: Alere INRatio2 PT/INR Professional Test Strips - Higher INR when Performed by Central Laboratory

 Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.  Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. More information 

 

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Comunicaciones de la FDA sobre la seguridad de los medicamentos en español

Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.govComunicaciones de la FDA 

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For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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PRODUCT APPROVALS & CLEARANCES

Approval  

FDA approves Entyvio to treat ulcerative colitis and Crohn's disease

FDA approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response.More information

FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks 

FDA allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. EMG electrodes detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. The electrodes send the electrical signals to a computer processor in the prosthesis that translates them to a specific movement or movements. More information

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FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients 

FDA approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs. More information 

 

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For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

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OPPORTUNITIES FOR COMMENT / GUIDANCES

 

Draft Guidance for Industry on Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Availability

This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product.Submit comments by August 12, 2014. More information

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

 

FDA is proposing to deem products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Submit comments by July 9, 2014. More information 

 

 

Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics: Public Meeting and Request for Comments

 

FDA seeks to obtain stakeholder input on the design and conduct of the postmarketing requirements (PMRs) for the class-wide extended-release/long-acting (ER/LA) opioid analgesic drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. The public meeting will be held on May 19 and 20, 2014, from 8 a.m. to 5 p.m. Submit either electronic or written comments by June 19, 2014More information 

 

Over-The-Counter Drug Monograph System — Past, Present and Future

 

FDA is interested in obtaining patient input on the impact of fibromyalgia on daily life and patients’ views on currently available therapies to treat the condition. In addition to providing input at the public meeting, patient stakeholders can provide their perspectives on the discussion questions through the public docket. The docket closes on May 26, 2014. To submit your comments, visit http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1041-0004More information 

 

 

Health IT Report

There are some areas of health information technology oversight that will benefit from continued engagement, including clinical decision support IT and electronic health records. For that reason, the FDA is opening a docket (FDA-2014-N-0339) to accept comments on the report. In the coming weeks the FDA will announce dates for a 3-day public meeting to discuss the report. More information  

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ANNOUNCEMENTS

Announcements  

FDA’s “Voice of the Patient:” Listening to Those Most Affected by Their Disease and Treatments 

Last year, FDA began the Patient-Focused Drug Development (PFDD) program to more systematically obtain the patient perspective on certain diseases and their treatments.  The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). More information

 

How Sweet It Is: All About Sugar Substitutes

Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods.More information

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Ensuring Pharmaceutical Quality Through International Engagement

 

The FDA has had to transform itself from a domestically-focused regulatory agency into a 21st century global health organization.  This transformation has come in the face of economic and technological changes that have revolutionized how we carry out our mission. We live in a world where other countries increasingly produce—at least in part—the food and medical products our consumers and patients use in their daily lives. More information

 

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How Long Should You Take Certain Osteoporosis Drugs?

An FDA review of clinical studies measuring the effectiveness of long-term bisphosphonates use shows that some patients may be able to stop using bisphosphonates after three to five years and still continue to benefit from their use, says Marcea Whitaker, M.D., a medical officer at FDA’s Center for Drug Evaluation and Research. Whitaker is one of the co-authors of the FDA review, which was published in the May 31, 2012 issue of The New England Journal of Medicine. More information 

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DRUG SHORTAGES AND DISCONTINUATIONS

 

FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov 

 

More information about drug shortagesshortages resolved, anddiscontinuations

Information about blood and biologic shortagesresolved shortages, and discontinuations   

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UPCOMING MEETINGS

FDA advisory committee meetings are free and open to the public.  No prior registration is required to attend.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

 

Other types of meetings listed may require prior registration and fees.  Click on "more information" for details about each meeting. 

 

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

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Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments (May 28-29)

 

The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing pregnancy registries and other methods of evaluating the post-approval safety profile of drugs and biological products in pregnant women. More information 

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Center for Devices and Radiological Health Guidance Development and Prioritization; Public Workshop; Requests for Comments (Jun 5)

 

The topics to be discussed include the FDA's Center for Devices and Radiological Health's (CDRH) guidance development process, guidance development best practices for FDA, CDRH, and CDRH stakeholders, and CDRH guidance priorities and priority development.

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