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 18, 2014

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 email subscribe here.

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Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form

Public Notification: Undeclared Drug Ingredient - La Jiao Shou Shen

FDA is advising consumers not to purchase or use La Jiao Shou Shen, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that La Jiao Shou Shen contains sibutramine and phenolphthalein. More information

FDA Warning: Potential Health Risks - Captomer and Captomer-250 by Thorne Research

FDA is warning consumers not to purchase or to use Thorne Research's Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid) as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. More information

Class I Recall: One Lot Mislabeled - Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm

FDA notified health professionals of a class I recall of this product due to one lot of 3.0mm sized connectors, Lot #2553426, which were mislabeled in packages as 3.5mm. The affected products were distributed in November 2013. More information

Recall: Labeling Error - Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast

Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. 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 Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body

FDA approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a squamous cell carcinoma has spread in the body's head and neck region. Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumor for cancer in patients with cancer of the head and neck. More information

FDA Approves the First Antihemophilic Factor, Fc Fusion Protein for Patients with Hemophilia A

FDA approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. 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

FDA Issues Draft Guidance for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind

FDA has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices. These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers. More information

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

FDA is extending the comment period on the proposed rule published on March 3, 2014. Submit either electronic or written comments by August 1, 2014. More information

ANNOUNCEMENTS

FDA Revamps Drug Shortages Website with Enhanced Search Features and Status Updates

The new website provides sections for new and updated drug shortages, a listing of drug shortages by therapeutic category, the ability to report a shortage via a web form, and sorting functions for drug shortages by generic name or status. More information

FDA and EPA Issue Draft Updated Advice for Fish Consumption

FDA and the U.S. Environmental Protection Agency issued draft updated advice on fish consumption. The two agencies have concluded pregnant and breastfeeding women, those who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain important developmental and health benefits. More information

FDA Takes Final Step on Infant Formula Protections

FDA oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them. FDA is finalizing a rule that sets standards for manufacturers of infant formula. More information

Consumer Update: Four Medication Safety Tips for Older Adults

FDA's recommendations for older adults taking prescription and over-the-counter medicines. 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.

Oncologic Drugs Advisory Committee Meeting Announcement (June 25)

The committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication 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

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (July 10-11)

The committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. More information

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (July 30-31)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. 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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