As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.

June 4, 2014

PRODUCT SAFETY

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Recall: Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion - Visible Particulates

Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30 mL concentrated solution for intravenous infusion. The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. More information.

FDA Safety Communication: Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator - Product Shortage

Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand. FDA recently held a teleconference for stakeholders on this topic. A replay of the teleconference is available until Jun 27 by calling 866-513-1233, passcode 1472.

ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line. ASP is able to ship only 30 percent of its normal capacity for the Sterrad Cyclesure 24 Biological Indicator. More information.

Class I Recall: NaturaLyte Liquid Bicarbonate Concentrate - Potential Health Risk

Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection.. More information.

Class I Recall: Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs - Prongs May Detach from Nasal Tubing and Interrupt Therapy

Fisher & Paykel Healthcare received 24 reports in which the affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. More information.

Class I Recall: Baxter ABACUS TPN Calculation Software - Software Errors May Cause Toxic/Overdose Symptoms

FDA notified health professionals of a Class I Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. Symptoms may be non-specific and include nausea, vomiting, dizziness or fatigue. More information.

Class I Recall: Maquet Datascope Intra-Aortic Balloon Pumps - Failure of Fan Assembly

FDA notified health professionals of a Class I Recall due to a fan assembly for the affected Intra-Aortic Balloon Pumps (IABP) that could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning. 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.

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 en druginfo@fda.hhs.gov. Comunicaciones de la FDA

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

PRODUCT APPROVALS & CLEARANCES

FDA approves first generic versions of celecoxib

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions. More information.

FDA allows marketing of first non-invasive test to help in identifying cause of certain kidney disease

Today, the U.S. Food and Drug Administration allowed marketing of the first test that can help determine if a specific type of kidney disease, called membranous glomerulonephritis (MGN), is due to the body's rejection of its own kidney tissue (autoimmune) or if it is due to another cause (such an infection). More information.

FDA approves Dalvance to treat skin infections

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. More information.

FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine

The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test — the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States. More information.

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

The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn's disease. More information.

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

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

Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Extension of Comment Period

The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's revision of the Nutrition and Supplement Facts Labels. More information.

ANNOUNCEMENTS

Indoor Tanning Raises Risk of Melanoma: FDA Strengthens Warnings for Sunlamp Products

Using sunlamp products such as tanning beds or tanning booths increases the risk of skin damage, skin cancer and eye injury, according to the Food and Drug Administration (FDA) and numerous other health organizations. A particularly dangerous result is melanoma, the deadliest type of skin cancer. More information.

FDA launches openFDA to provide easy access to valuable FDA public data

The U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA's publicly available data accessible in a structured, computer readable format. More information.

Sometimes Drugs and the Liver Don't Mix

When the liver is working well, our metabolism hums along in equilibrium. But drugs and dietary supplements can sometimes wreak havoc with that system, leading to dangerous liver problems. The Food and Drug Administration (FDA) is working to prevent drug-induced liver injuries. More information.

Lupus Therapies Continue to Evolve

It can be a difficult disease to diagnose and a difficult disease to treat. It's called lupus, and as many as 24,000 people in the United States are diagnosed with the disease each year. More information.

Always Tired? You May Have Sleep Apnea

Obstructive sleep apnea, the most common type, is caused by a blockage of the airway, usually when the soft tissue in the back of the throat collapses. The less common form, central sleep apnea, happens if the area of your brain that controls breathing doesn't send the correct signals to your breathing muscles. More information.

Skin Cancer Patients Have More Treatment Options

Science is discovering new ways to attack cancer cells on different fronts. Since 2011, the Food and Drug Administration (FDA) has approved five drug treatments for melanoma and other skin cancers, giving patients more options to meet their specific needs. Today, patients have better treatments, better outcomes and a longer life. More information.

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.

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. More information

Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (Jun 6)

The committee will discuss, make recommendations, and vote on information related to the premarket approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) submitted by applicant AcuFocus, Inc. The KAMRA Inlay is a permanent corneal implant that is placed intrastromally in a corneal pocket or under a corneal flap. More information

Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction; Public Workshop (Jun 9)

The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products. More information

Public Meeting on Patient-Focused Drug Development for Neurologic Manifestations of Inborn Errors of Metabolism (Jun 10)

The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neurologic manifestations of inborn errors of metabolism on daily life as well as patient views on treatment approaches for neurologic manifestations of inborn errors of metabolism. More information

Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12)

FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled "FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices." More information

Anesthetic and Analgesic Drug Products Advisory Committee (Jun 12)

The committee will discuss the potential cardiovascular risk associated with products in the class of peripherally acting opioid receptor antagonists and the necessity, timing, design, and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee (Jun 12)

The committee will discuss, make recommendations, and vote on information related to the premarket approval application for the LUTONIX 035 Drug Coated Balloon PTA Catheter sponsored by Lutonix, Inc. More information

Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24)

FDA is announcing the following public workshop: "The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women." CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information

Oncologic Drugs Advisory Committee Meeting Announcement (Jun 25)

The committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy. More information

Public Meeting: Proposed Rules on Food Labeling - Revision of the Nutrition and Supplement Facts Labels & Serving Sizes of Foods (Jun 26)

FDA will discuss the proposed rules aimed at updating nutrition information and serving size requirements on the Nutrition and Supplement Facts labels to provide consumers with information that could be used to maintain healthy dietary practices. More information.

RESOURCES

MedWatchLearn - Practice Reporting to FDA!

This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information

FDA Basics

Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

FDA Voice

FDA voice is the official blog from FDA's senior leadership and staff. More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information

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