Sentinel: Harnessing the Power of Databases to Evaluate Medical Products
As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs (formerly the Office of Special Health Issues) 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.
March 27, 2014
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Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients
Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. More information
New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients
Undeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established. More information
Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin
Exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. More information
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information
Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock
The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock. More information
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products
Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention. More information
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results
Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. More information
McKesson Technologies Anesthesia Care: Recall – Patient Case Data May Not Match Patient Data
VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter
Risk of rare but serious adverse events associated with infusion containing particulates. More information
Reumofan Plus: Recall - Undeclared Drug Ingredient
UPDATED - Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. More information
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine
Presence of oxidized stainless steel particulate may put a patient at risk from strong magnetic field exposure such as MRI, and other adverse events resulting in serious life-threatening complications. 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 email@example.com. 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 Otezla to treat psoriatic arthritis
FDA approved Orezla for the treatment of psoriatic arthritis. PsA is a form of arthritis that affects some people with psoriasis.
FDA approves first implantable hearing device for adults with a certain kind of hearing loss
The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids. More information
FDA approves Impavido to treat tropical disease leishmaniasis
Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire leishmaniasis overseas. Impavido is an oral medicine approved to treat the three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). It is intended for patients 12 years of age and older. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis. 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
Public Hearing on FDASIA Section 907
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data (i.e. sex, race/ethnicity, and age) in applications for approval of FDA‐regulated medical products. The Agency will utilize input from this public hearing to develop a plan that is pragmatic and public‐health focused. There will be an opportunity for attendees to make oral presentations during the meeting. The deadline for registering as a presenter is March 21, 2014. There is also an open public docket for the meeting. Comments will be accepted until May 16, 2014. More 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-1041-0004. More information
Homing in Faster on Potentially Deadly Bacteria in Food
Whether an outbreak of foodborne illnesses is caused by Listeria in cantaloupe, E.coli in salad or Salmonella in peanut butter, the faster the disease-causing bacteria are identified, the more illnesses can be averted. More information
Sentinel: Harnessing the Power of Databases to Evaluate Medical Products
Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves it. Occasionally, rare and unexpected health problems (which we call "adverse events") become apparent only after a medical product is on the market and many more people use it. More information
Mexico and the U.S.: Progress on Food Safety Partnerships
Spring may be on the way, but it's still winter weather in most areas of the country. If you are enjoying fresh avocados, berries or grapes, there is a good chance they came from Mexico. In fact, about two-thirds of the fresh produce imported into the United States comes from our neighbor to the south. More information
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 firstname.lastname@example.org
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.
Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products (Mar 31)
FDA hopes to bring together a broad range of stakeholders of cellular therapies and regenerative medicine products in order to inform stakeholders about the types of standards and standards organizations that are available currently, the role that the Federal Agencies play in standards development, and the potential role that stakeholders can play in standards development. More information
The committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, and NDA 021-883, dalbavancin hydrochloride for intravenous injection for the proposed indication of treatment of acute bacterial skin and skin structure infections. More information
Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 (Apr 1)
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data (i.e. sex, race/ethnicity, and age)in applications for approval of FDA‐regulated medical products.
On April 16, 2014, the committee will consider scientific issues pertaining to dependence and addiction. On April 17, 2014, the committee will receive information on population modeling in the assessment of tobacco product applications and discuss the ways modeling can inform decisions critical to population health. More information
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Request for Comments (Apr 24)
On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. More information
Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice Conference (May 15-16)
FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. More information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (May 21-22)
On May 21, the committee will discuss the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101). More information
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
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 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