FDA Updates for Health Professionals

August 23, 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 Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all. More information Working to Improve Information on Medication Use during Pregnancy When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages.  But what to do about prescription drugs is a more complicated topic. There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical practice must prescribe needed medicines to pregnant women to treat a variety of illnesses and conditions such as diabetes, high blood pressure or even something as simple as a dental infection. Indeed, about half of the 6.3 million women who are pregnant every year take at least one medication, and prescription use is on the rise, up by more than 60 percent from 1976 through 2008. More information is clearly needed. The 21st Century Cures Act, which was enacted in 2016, established a task force to consider what is being done to identify and address gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. More information FDA warns of potential contamination in multiple brands of drugs, dietary supplements FDA is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. The drug and dietary supplement products made by PharmaTech include liquid docusate sodium drugs (stool softeners), as well as various dietary supplements including liquid vitamin D drops and liquid multivitamins marketed for infants and children. More information FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection  FDA announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, M.D. “By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.” More information OPPORTUNITIES FOR COMMENT / GUIDANCES Peripheral and Central Nervous System Drugs Advisory Committee FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4835. The docket will close on September 27, 2017. Submit either electronic or written comments on this public meeting by September 27, 2017. More information Advancing the Development of Pediatric Therapeutics: Application of “Big Data” to Pediatric Safety Studies; Public Workshop The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies.” The purpose of this 2-day workshop is to understand how to access and analyze “Big Data” associated with safety information in the health care setting, and the utility and challenges associated with the use of “Big Data” to study the safety of therapeutics in children. More information Use of Prescription Opioid Products Containing Hydrocodone or Codeine for the Treatment of Cough in Pediatric Patients On September 11, 2017, the Pediatric Advisory Committee will discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion will include current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients. FDA is establishing a docket for public comment on this document. The docket number is FDA-2017-N-4885. The docket will close on September 13, 2017. More information PRODUCT APPROVALS & CLEARANCES Marketing of the ID-FISH Plasmodium Genus Test Kit and the ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit Allowed  FDA allows the marketing of the ID-FISH Plasmodium Genus Test Kit and the ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit to test for malaria. Traditional light microscopy remains a clinically relevant standard for detecting malaria parasites; however, it requires both training and experience for a microscopist to be able to accurately detect parasites and identify the species. The performance of traditional light microscopy has been reported to vary between facilities due to varying degrees of training and expertise. Fluorescence in situ hybridization (FISH) is a technique in which fluorescently labeled DNA probes bind to target nucleic acids in the sample which is then viewed with a fluorescence microscope. The ID-FISH Plasmodium test kits can assist microscopists in detecting and identifying malaria parasites in the sample, and they may be particularly valuable at sites where personnel have less experience or training in interpreting malaria smears under traditional light microscopy staining techniques. More information FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia FDA approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.” 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. Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events. More information Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces. More information Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of Blunt Traumatic Aortic Injury (BTAI) because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death. More information Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted. Amneal learned about the issue from a Consumer's report. To date no adverse events related to these dropper defects have been reported to Amneal. See the press release for product photos and a listing of affected lot numbers. There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose. More information Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A. This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets. If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. More information Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination The distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination. Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC. More information Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction). 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 Pediatric Advisory Committee Meeting Announcement (Sep 11) The Pediatric Advisory Committee will meet to discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. The discussion will include current practice for the treatment of cough in children and benefit-risk considerations regarding the use of prescription opioid products in pediatric patients. More information Pediatric Advisory Committee Meeting Announcement (Sep 12)   The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for Abilify (aripiprazole), Keppra and Keppra XR (levetiracetam), CONTEGRA Pulmonary Valved Conduit (humanitarian device exemption (HDE), ENTERRA Therapy System (HDE),   PLEXIMMUNE (HDE), and ELANA Surgical Kit (HDE). 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 UPDATED PUBLIC PARTICIPATION INFORMATION: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement (Sep 14) The public participation information has been changed for the September 14, 2017, joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The deadline for making formal oral presentation requests has been changed from Tuesday, August 22, 2017 to Monday, August 28, 2017 and the contact person will now notify interested persons regarding their request to speak by Tuesday, August 29, 2017. All other information remains the same. 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 Peripheral and Central Nervous System Drugs Advisory Committee (Sep 28) The committee will discuss new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. More information Patient Engagement Advisory Committee Meeting Announcement (Oct 11-12) (FDA) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (PEAC).  The general function of the committee is to provide advice and recommendations to the Agency on complex issues relating to medical devices, the regulation of devices, and their use by patients.  The meeting will be open to the public.  This meeting will be the inaugural meeting of a new advisory committee. DATES: The meeting will be held on October 11, 2017, from 1 p.m. to 5 p.m. and October 12, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy, Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900.  Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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