FDA Updates for Health Professionals

August 09, 2017

UPDATES FOR HEALTH PROFESSIONALS Office of Health and Constituent Affairs ANNOUNCEMENTS OPPORTUNITIES FOR COMMENT / GUIDANCES PRODUCT APPROVALS & CLEARANCES PRODUCT SAFETY UPCOMING MEETINGS RESOURCES ANNOUNCEMENTS FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare The new Pre-Cert for Software Pilot Program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings. At the same time, FDA’s Center for Devices and Radiological Health is publishing its Digital Health Innovation Action Plan to provide details and timelines for our integrated approach to digital health technology and the implementation of the 21st Century Cures Act. More information FDA to expand public education campaign to focus on prevention of youth e-cigarette use FDA announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS. More information OPPORTUNITIES FOR COMMENT / GUIDANCES Request for comment by August 10, 2017: Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy The FDA announced a public meeting and an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the impacts of neuropathic pain associated with peripheral neuropathies. More information Request for comment by August 28, 2017: Current Good Manufacturing Practice for Medical Gases; Draft Guidance for Industry FDA announced the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice for Medical Gases.” When finalized, this guidance will represent FDA's current thinking on the manufacture, processing, packing, and holding of medical gases in compliance with applicable CGMP regulations (21 CFR parts 210 and 211). This guidance does not address every potentially applicable CGMP requirement. Instead, it addresses those requirements that are considered most critical to the safety of medical gases, that have been the subject of industry questions, or for which FDA has otherwise determined compliance recommendations are appropriate. More information PRODUCT APPROVALS & CLEARANCES FDA approves Mavyret for Hepatitis C FDA approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. More information FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia FDA approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine. More information FDA approves treatment for chronic graft versus host disease The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. More information FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed PRODUCT SAFETY MedWatch, The FDA Safety Information and Adverse Event Reporting Program For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here. Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead FDA is warning parents and caregivers not to use “Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine” due to the risk of lead poisoning. FDA has not reviewed this product for safety or effectiveness. Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system. In children, chronic exposure to lead—even at low levels—is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems. More information System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy. More information Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with  polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions.  The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx, located in Irvine, California. Hypersensitivity reactions to intravenous (IV) products containing polyethylene glycol castor oil have been reported in the literature and are the subject of warnings for a number of FDA-approved drugs. More information Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech LLC. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population. More information Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil. The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. More information 0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences. More information Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center in Dallas, Texas, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, Texas, by physicians affiliated with Tylock-George Eye Care. More information Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg. 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. Pediatric Trial Design and Modeling: Moving into the Next Decade (Sep 8) The Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration is announcing a public workshop entitled “Pediatric Trial design and Modeling: Moving into the next decade” More information Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population (Sep 12) FDA's Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES), is hosting a one day public workshop entitled “Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population.” The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes, in order to reduce the risk of serious hypoglycemia, identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease, discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients, and disseminate the results of this discussion to inform patients, patient advocates, and healthcare practitioners. More information Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Sep 13) On September 13, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) [Shingrix], manufactured by GlaxoSmithKline Biologicals. More information Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement (Sep 19) The committee will discuss supplemental new drug application (sNDA) 021938/033 SUTENT (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. More information RESOURCES For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program 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 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   Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. 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 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