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 PRODUCT SAFETY
Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changesThe U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. We have approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions. Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives. Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related. More information Drug Safety Communication: Rare but Serious Risk of Heart Attack and Death with Use of Cardiac Nuclear Stress Test Agents Lexiscan and AdenoscanThe U.S. Food and Drug Administration (FDA) is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). We have approved changes to the drug labels to reflect these serious events and updated our recommendations for use of these agents. Health care professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. More information Recall: Hydravax Dietary Supplement by IQ Formulations – Possible Undeclared Drug IngredientIQ Formulations, of Sunrise, Florida is initiating a recall of all lots of its 45-capsule bottles of Hydravax due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of Hydravax (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic. Diuretics are prescription drugs and thus, are not listed on the packaging label for Hydravax. Consumers are hereby notified not to use the product. More information
Recall: FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott – Erroneously Low Blood Glucose ResultsAbbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both “FreeStyle Blood Glucose Meter” and “FreeStyle Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod Insulin Management System. When the test strips are used with the newer FreeStyle brand meters including FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose Meter and FreeStyle Freedom Lite Blood Glucose Meter, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx Blood Glucose Meter is not affected by this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test strips. More information Recall: Nitroglycerin in 5% Dextrose Injection by Baxter – Particulate MatterBaxter International Inc has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism (blockage of blood vessels). Other adverse events associated with injection of particulate matter include inflammation due to foreign material, particularly in the lungs, and local irritation of blood vessels. More information Recall: Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits – Bag-to-Vent Switch in CAS I/II Absorbers May FailFDA notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. More information Recall: CLR Medicals International Inc. Viscoelastic Products – Quality System Deficiencies And Lack Of Premarket Approval (PMR)CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers. No injuries have been reported to date for the Viscocel and Viscocel Plus products, however, multiple cases of endopthalmitis were reported in 2011 for the firm’s Visco Supreme, a similar product manufactured at the firm under the same conditions. More information Recall: Hospira GemStar Infusion System – Pressure Sensor Calibration DriftThe proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test or resulting in an error being reported during device setup or infusion (refer to Recall Notice for list of errors). More information Safety Communication: HeartStart Automated External Defibrillators (AED) From Philips Healthcare – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate ShockFDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. More information Other RecallsSee all recalls, market withdrawals and safety alerts online
PRODUCT APPROVALS
FDA approves new treatment for hepatitis C virusThe U.S. Food and Drug Administration approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection. More information (English or Spanish) FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenzaThe U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. The vaccine will supplement National Stockpile and is not intended for commercial availability. More information (English or Spanish)
OPPORTUNITIES FOR COMMENT / GUIDANCESFederal Register Notices Related to the Drug Quality and Safety ActOn November 27, 2013 the President signed the Drug Quality and Safety Act. The Act contains important provisions relating to the oversight of human drug compounding. The new law also contains provisions to help secure the drug supply chain, including a new uniform Federal framework for identifying certain prescription drugs and tracing their transaction history as these products move from the manufacturer to the pharmacy. The following documents are available for comment
Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment
The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment” issued on September 14, 2010. Submit either electronic or written comments on the draft guidance by December 23, 2013. More information
Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment
The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination. Submit either electronic or written comments on the draft guidance by February 4, 2014. More information
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document identifies applicable legal requirements under the Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). Hearing aids and PSAPs both affect our ability to hear sound, but the products have different intended uses, and are therefore subject to different regulatory controls. Submit either electronic or written comments on the draft guidance by February 7, 2014. More information Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessThe Food and Drug Administration (FDA) has determined that BANZEL (rufinamide) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for rufinamide tablet, 100 mg, if all other legal and regulatory requirements are met. More information Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration StaffThe Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.” This guidance document is intended for manufacturers and distributors of “for research use only” (RUO) and “for investigational use only” (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products, as well as FDA staff. More information Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical ProductsThe Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information regarding the Adverse Event Program for medical devices. Submit either electronic or written comments on the draft guidance by January 28, 2014. More information
ANNOUNCEMENTS
New Law Enhances Safety of Compounded Drugs and Protection of the Drug Supply ChainSince last year’s tragic meningitis outbreak and subsequent events involving compounded drugs, Congress has been hard at work to pass new legislation to provide FDA with the appropriate authorities for regulating compounded drugs to help make these products safe for the American public. More information
Court order keeps food company from production until it cleans upA Bakersfield, Calif., food company has agreed under terms of a court order not to process or distribute food until after it cleans up the unsanitary conditions found by U.S. Food and Drug Administration inspectors. More information
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccinationA new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S. Food and Drug Administration (FDA) and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated. More information
FDA requires removal of certain restrictions on the diabetes drug AvandiaThe U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today’s actions are consistent with the recommendations of expert advisory committees. Results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007. More information Meridian Medical Technologies Auto-Injectors: Extension of Expiration DatesFDA is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors manufactured by Meridian Medical Technologies, a Pfizer Inc. company. FDA and Meridian are working together to resolve the disruption as quickly as possible, but it is unclear how long this disruption may persist .Health care providers and emergency response personnel who have any of the auto-injectors manufactured by Meridian identified that are nearing or beyond the labeled expiration date should retain the products until FDA is able to provide additional information regarding the continued use of these products. More information
UPCOMING MEETINGSFDA 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. Medical Gas Regulation Review Public Meeting (Dec 6)FDA is announcing a public meeting on whether any changes to Federal drug regulations are necessary for medical gases as part of the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA). More information Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting (Dec 9)
The committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio). More information
Public Meeting: Fibromyalgia – Patient-Focused Drug Development (Dec 10)
The public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. More information
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Dec 11)
The committee will discuss the safety and efficacy of biologic licensing application, metreleptin for injection. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. More information
Circulatory System Devices Panel of the Medical Devices Advisory Committee (Dec 11)
The committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology. More information
Allergenic Products Advisory Committee (Dec 11 &12)
The committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair and Grastek. More information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (Dec 12)
The committee will discuss and make recommendations regarding the classification of spinal sphere devices, stair climbing wheelchairs, and mechanical wheelchairs. More information
Endocrinologic and Metabolic Drugs Advisory Committee (Dec 12)
The committee will discuss the efficacy and safety of new drug application (NDA) 202293, dapagliflozin tablet, submitted by Bristol-Myers Squibb. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. More information
FDA/American Gastroenterological Association (AGA) Co-sponsored Public Workshop: Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases (Dec 19 & 20)
The purpose of this workshop is to bring together key stakeholders in the development and delivery of new medical technologies. Through this workshop, stakeholders will be able to better clarify their roles and expectations as it pertains to assessing the risk and benefit of medical device procedures, approval, commercialization and coverage. More information
Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases (Jan 6-7)The purpose of the workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selections; and to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases. FDA is seeking input on these topics from academic, clinical, and treating communities; patients and advocacy groups; industry; and government agencies. More information Public Workshop – Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases (Jan 8)The purpose of the workshop is to discuss issues related to the following broad topics associated with medical devices for the diagnosis and treatment of pediatric patients affected by rare diseases: Current approaches toward use of medical devices for pediatric clinical practice; Humanitarian Device Exemption (HDE) marketing pathway, including the Humanitarian Use Device (HUD) designation process; Pediatric Specialty-Specific Practice Areas; Clinical Trials; Registries; Pediatric Needs Assessment; and Possible Approaches to Advancing Pediatric Medical Device Development. FDA is seeking input from these topics from academicians, clinical practitioners, patients and advocacy groups, industry, and governmental agencies. More information
RESOURCES
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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