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SCVNews.com | FDA: Drug Safety Updates & Approvals | 12-26-2012
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Product Safety Bar

HeartDrug Safety Communication: Pradaxa Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves
FDA is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial) was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves. More informationDrug Safety Communication: Warning Against Use of Xyrem (sodium oxybate) With Alcohol or Drugs Causing Respiratory Depression
FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided. The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death. More informationRecall: Zicam Extreme Congestion Relief Due to Contamination With Burkholderia cepacia
Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples from the same lot have shown no evidence of the organism. Burkholderia cepacia poses little medical risk to healthy individuals. However, Burkholderia cepacia in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in individuals with a compromised immune system or those with chronic lung conditions, such as cystic fibrosis. The organism is resistant to many antibiotics and may be difficult to eradicate in this sensitive population if an infection occurs. More informationDietary Supplement Reumofan Plus relabeled and sold as “WOW”
FDA is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”  The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.  FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant).  These ingredients have the potential to cause serious injury.
More information
IV BagRecall: Visible Particulate Matter Identified in Carboplatin Injection by Hospira
Hospira, Inc. is further informing the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. If particulate matter from crystallization is injected into a patient, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible. More informationPraxair, Inc. has Initiated a Voluntary Recall Affecting Grab ‘n Go® Vantage Portable Oxygen Cylinder Units
Praxair, Inc. (NYSE: PX) announced that it is in the process of conducting a voluntary recall involving Grab ‘n Go Vantage portable oxygen cylinder units. Praxair is making a minor modification to the affected units as they come in for routine servicing and filling.  Praxair has already communicated with its customers and FDA. Praxair initiated this field correction after becoming aware of a few isolated incidents of ignition inside Grab ‘n Go oxygen cylinders that had been knocked over and subject to significant physical impact. Based on the preliminary results of Praxair’s review of these few incidents, it appears that Grab ‘n Go units fitted with certain equipment (a type of o-ring) may be more prone to this type of incident. Out of an abundance of caution to protect patient safety, Praxair has been making a minor modification to affected units. As units come in for routine servicing and filling, the unit is being inspected and, if necessary, the o-ring that sits between the valve and the cylinder is being replaced. To date, over 50% of the units in the United States already have been modified. Modified units have a decal with a “T” affixed to their green shroud. More informationDrug Safety Communication: Incivek (telaprevir) in Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek combination treatment) May Cause Serious Skin Reactions
Incivek is a hepatic C virus NS3/4A protease inhibitor indicated in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including patients who have cirrhosis, are treatment-naïve, or who have been previously received interferon-based treatment. FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). Some patients died when they continued to receive Incivek combination treatment after developing a worsening, or progressive rash and systemic symptoms (symptoms affecting the entire body). More informationRecall: Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova Contain Undeclared Ingredients Sufoaildenafil and Thioaildenafil
Performance Plus Marketing, Inc. Issues a Voluntary Nationwide Recall of Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova because they contain undeclared Sulfoaildenafil and Thioaildenafil. Sulfoaildenafil and thioaildenafil are close in structure to sildenafil and are expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
More information
burgandy fingerComunicaciones 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
MedWatch Image

For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.


Product Short and DC

Syringe and vialsFDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients.  FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information

 

Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:

 

  • Aminophylline
  • Calcium Chloride Injection
  • Papaverine Hydrochloride Injection

 

Drugs to be Discontinued Announced During Past 2 Weeks:

 

  • Atropine 1% 2mL Steri-units Unpreserved
  • Isopto Carbachol 1.5% and 3% 15mL
  • Isopto Homatropine 2% and 5% 5mL
  • Isopto Hyoscine 0.25% 5mL
  • Ondansetron Injection 32 mg/50 mL premixed bags (NDC 0409-4760-24)
  • Ursodiol Tablets, USP 250 mg, 100 (NDC 00093-5360-01), 500 mg, 100 (NDC 00093-5361-01)

 

 

 

 

 

 

 

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Product Approval Bar

IclusigFDA approves Iclusig to treat two rare types of leukemia
FDA approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases. Iclusig is being approved more than three months ahead of the product’s prescription user fee goal date of March 27, 2013, the date the agency was scheduled to complete review of the drug application. FDA reviewed the Iclusig drug application under the agency’s priority review program, which provides for an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Iclusig blocks certain proteins that promote the development of cancerous cells. The drug is taken once a day to treat patients with chronic, accelerated, and blast phases of CML and Ph+ ALL whose leukemia is resistant or intolerant to a class of drugs called tyrosine kinase inhibitors (TKIs). Iclusig targets CML cells that have a particular mutation, known as T315I, which makes these cells resistant to currently approved TKIs.
More informationFDA approves Varizig for reducing chickenpox symptoms
FDA has approved Varizig for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. Varizig is a varicella zoster immune globulin preparation. Varicella zoster virus (VZV) causes chickenpox in children and shingles in adults. Varizig is the only FDA approved immune globulin for VZV after exposure available in the United States. It was designated as an orphan drug by the FDA and received a priority review. Most people in the United States have immunity to VZV from vaccination or from having had chickenpox during childhood. However, people without immunity to VZV who are exposed to the virus may experience severe infections that are sometimes fatal. People most at risk include children or adults with weakened immune systems, pregnant women, and infants exposed during pregnancy or after birth. Occasionally, healthy people without immunity to VZV may contract severe infections. Antiviral treatments are not always effective and cannot be used in some cases. More informationFDA approves new orphan drug for rare cholesterol disorder
FDA approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments. HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol, often called the “bad” cholesterol, from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in approximately one in one million individuals. For those with HoFH, heart attacks and death often occur before age 30. Juxtapid works by impairing the creation of the lipid particles that ultimately give rise to LDL. Juxtapid is a capsule taken once a day, without food, and at least two hours after the evening meal. Patients should take supplements that contain fat-soluble vitamins and essential fatty acids daily while taking Juxtapid. More informationFDA expands Tamiflu’s use to treat children younger than 1 year
FDA expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days. The drug is not approved to prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old. Tamiflu was approved in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days. It has since been approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than two days, and to prevent flu in adults and children ages 1 year and older. More information

FDA approves Gattex to treat short bowel syndrome
FDA approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition). SBS is a condition that results from the partial or complete surgical removal of the small and/or large intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition. Gattex is an injection administered once daily that helps improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition. It is the third FDA-approved drug to treat adults with SBS receiving nutritional support. Zorbtive (somatropin) and Nutrestore (glutamine) were approved in 2003 and 2004, respectively. More information

FDA approves raxibacumab to treat inhalational anthrax
FDA approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab is a monoclonal antibody that neutralizes toxins produced by B. anthracis that can cause massive and irreversible tissue injury and death. A monoclonal antibody is a protein that closely resembles a human antibody that identifies and neutralizes foreign material like bacteria and viruses. Anthrax is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air. The FDA granted raxibacumab fast track designation, priority review, and orphan product designation. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively. More information

FDA approves Signifor, a new orphan drug for Cushing’s disease
FDA approved Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery. Cushing’s disease is caused by over-production of cortisol, a hormone made by the adrenal glands. A tumor in the pituitary gland leads to overstimulation of the adrenal gland, which results in excess cortisol production. Cortisol regulates many important functions in the body, including response to stress and injury. Patients with Cushing’s disease may have increased weight, glucose intolerance or diabetes, high blood pressure, easy bruising, and increased risk for infections. More information

FDA permits marketing of device to seal lung punctures
FDA is allowing marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions. The system reduces the risk of a patient experiencing a collapsed lung during a percutaneous transthoracic needle lung biopsy (a biopsy performed through the chest wall). A collapsed lung occurs when air from the lung leaks into the space around it, preventing the lungs from expanding properly. The condition can cause chest pain, shortness of breath, and cardiovascular distress and is particularly dangerous in patients who have lung disease. More information

 

Drugs@FDAFor information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

Comments and Guidances

FDA EmblemGuidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies
This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3). This document provides guidance to sponsors and investigators on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of BA and BE studies that are exempt from the IND requirements. This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators.More information
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide
This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).More information
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions – Effect on FDA Review Clock and Goals
The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.More information
Request for Comments: Framework for Pharmacy Compounding – State and Federal Roles
FDA is soliciting either comments on the issues discussed in section II of this document. Comments are due by January 18, 2013. More information
Request for Comments: Custom Devices
FDA is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption. FDA is seeking information on and examples of appropriate uses of the custom device exemption identified in section 520(b) of the FD&C Act. FDA encourages all stakeholders, including patients, physicians, dentists, and manufacturers, to submit comments on the appropriate use of this statutory provision. Comments are due by January 18, 2013. More information

 

Request for Comments: Draft Guidance for Industry – Electronic Source Data in Clinical Investigations
FDA is announcing the availability of a draft guidance for industry entitled “Electronic Source Data in Clinical Investigations.” This document revises and updates the draft guidance entitled “Electronic Source Documentation in Clinical Investigations.” This revised draft document provides guidance to sponsors, CROs, data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. Comments are due by January 22, 2013. More information

Request for Comments: Draft Guidance for IRBs, Clinical Investigators, and Sponsors – IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed
This draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. Comments are due by January 22, 2013. More information

 

Draft Guidances for Industry: Safety Considerations for Product Design to Minimize Medication Errors
This draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. Comments are due by February 11, 2013. More information

Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds
Food allergy is an immune-mediated sensitivity to foods that can lead to life-threatening adverse reactions. Because there is no cure for food allergy, allergic consumers must use avoidance to prevent allergic reactions. Successful avoidance requires, among other things, that allergic consumers and their caregivers be able to read and understand the ingredient lists on packaged foods. Comments are due by February 12, 2013. More information

Request for Comments: Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
FDA is announcing the availability of a draft guidance for industry entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Comments due by February 15, 2013. More information

Kidney Dialysis MachineRequest for Comments: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Comments are due by February 15, 2013. More information
Request for Comments: Draft Guidance for Industry – Development of Vaginal Microbicides for the Prevention of Human Immunodeficiency Virus Infection
FDA is announcing the availability of a draft guidance for industry entitled ‘‘Vaginal Microbicides: Development for the Prevention of HIV Infection.’’ The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides.Comments are due by February 21, 2013. More informationRequest for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy and Public Workshop
FDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. To attend workshop, registration is required by February 1, 2013. Comments are due by March 11, 2013.
More information 

Request for Comments: Draft Guidance for Industry and FDA Staff – Design Considerations for Devices Intended for Home Use
FDA is announcing the availability of the draft guidance entitled “Design Considerations for Devices Intended for Home Use.” This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Comments are due by March 13, 2013. More information

Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy
FDA invites comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. Comments are due by April 8, 2013. More information


Announcements Bar

Santa AnnouncementFDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
FDA warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events. The five providers that received FDA Warning Letters are:

  • 20/20 Institute Indianapolis LASIK, of Indianapolis
  • Scott Hyver Visioncare Inc., of Daly City, Calif.
  • Rand Eye Institute, of Deerfield Beach, Fla.
  • Eye Center of Texas, of Bellaire, Texas
  • Woolfson Eye Institute, of Atlanta

More information

Invacare signs consent decree to correct wheelchair manufacturing problem
FDA announced that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components. Once the consent decree is entered into the court, Invacare will not be able to resume normal business operations at two of its Elyria, Ohio, facilities until it corrects all violations listed in the consent decree and it has been notified by the FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act (the Act). The Act requires medical device companies to follow current good manufacturing practice and to follow strict guidelines in reporting adverse events to FDA. To comply with current good manufacturing practice, a medical device company must establish and follow specific procedures, which are outlined in FDA’s Quality System regulations, to prevent quality problems in their devices.  Seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of FDA’s Quality System regulations, along with failures to properly report adverse events to the agency. More information

Update: Multistate outbreak of fungal meningitis and other infection
FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species,and Penicillium species. Although rare, some of the identified Bacillus species can be human pathogens. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically. More information


Robert TempleStrategies for More Successful Drug Trials, by Bob Temple, M.D., Deputy Director for Clinical Science in FDA’s Office of Drug Evaluation and Research
In recent months, drug developers have succeeded in bringing important drugs to market for cystic fibrosis, cancer and other conditions by employing strategies for achieving greater clinical trial success.Today FDA is issuing a draft guidance that spells out how drug developers can use such strategies, known as clinical trial enrichment, to greatly increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective. These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs.To read the rest of this blog, see FDA Voice Blog, December 17, 2012. For a copy of the draft guidance, see Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.

Margaret Hamburg - Global Food SafetyImproving the World through Improved Food Safety, by Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration
Food safety may seem an unusual issue for a lending institution created to encourage growth and reduce poverty in developing countries.The World Bank, however, rightly notes that food safety is not only about public health, as important as that is. It is also critical for economic development, expanded market access and trade, and ultimately for the alleviation of poverty. This week in Paris, the World Bank held its first Global Food Safety Partnership Conference and I was immensely pleased to be able to participate.To read the rest of this blog, see FDA Voice Blog, December 13, 2012.

Ucoming Meetings Bar

Advisory Committee Meeting sign
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.

January 2012

Endocrinologic and Metabolic Drugs Advisory Committee Meeting
Date: January 10, 2013
The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. More information

 

Cellular, Tissue and Gene Therapies Advisory Committee Meeting
Date: January 15, 2013
On January 15, 2013 from 2 p.m. to approximately 4:30 p.m., the Committee will meet, by teleconference, in open session, to hear updates on the research programs in the Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA.  From approximately 4:30 p.m. to 5:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).  The committee will discuss reports of the intramural research programs and make recommendations regarding personnel staffing decisions. More information

Drug Safety and Risk Management Advisory Committee Meeting
Dates: January 24-25, 2013
The committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II.
More information

Man using inhalerPulmonary-Allergy Drugs Advisory Committee Meeting
Date: January 29, 2013
The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. More informationPulmonary-Allergy Drugs Advisory Committee Meeting
Date: January 30, 2013
The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function. More information

February

Public Hearing: Impact of Approved Drug Labeling on Chronic Opioid Therapy
Dates: February 7-8, 2013
Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. The July 9, 2012, approval of the Risk Evaluation Management Strategy for extended-release (ER) and long-acting (LA) opioid analgesics is a recent example of FDA’s ongoing commitment to ensuring that the benefits of these types of opioid drugs continue to outweigh their risks. More information

Public Workshop: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy
Dates: February 11-12, 2013
FDA is announcing this public workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. More information

 

Risk Communication Advisory Committee Meeting
Date: February 12, 2013
The committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception. More information

 

Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
Date: February 22, 2013
The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information

March

Pulmonary-Allergy Drugs Advisory Committee Meeting
Date: March 7, 2013
The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information

April

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
Date: April 5, 2013
The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.
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fingerPlease visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

Consumer Update bar

Yawning manAlways Tired? You May Have Sleep Apnea
Your spouse says your snoring is driving her nuts. You wake up feeling unrested and irritable. You nod off at the computer—or worse, at the wheel. These are common signs that you may have obstructive sleep apnea (OSA), a sleep disorder that—left untreated—can take its toll on the body and mind. Untreated OSA has been linked to high blood pressure, heart attacks, strokes, car accidents, work-related accidents and depression. According to the American Sleep Association, OSA affects more than 12 million Americans. FDA regulates the safety and effectiveness of devices, including the device most often used to treat OSA—the Continuous Positive Airway Pressure machine, commonly known as CPAP. More informationFederal judge enters order imposing restrictions on Sunland Inc.
U.S. District Judge William P. Johnson of the District of New Mexico has signed a consent decree imposing requirements on Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney, to keep potentially harmful products from entering the marketplace, FDA said. On Nov. 26, 2012, FDA suspended Sunland’s registration because it did not provide enough assurance that existing problems would be corrected. This was the first use of the agency’s authority to prohibit a food facility from introducing product into interstate or intrastate commerce, an authority granted to the agency under the FDA Food Safety Modernization Act of 2011. More informationBuying Medicines Online? Be Wary, FDA Says
When it comes to buying prescription medicines online, it’s better to be safe than sorry. BeSafeRx: Know Your Online Pharmacy, a new public education campaign by FDA, is aimed at helping consumers understand and minimize the risks of buying medicines online. The Internet makes it easier for fraudulent and illegal online pharmacies to sell medicines to American consumers outside the system of federal and state safeguards that protect patients from inappropriate or unsafe medicines. Medicines you purchase from fraudulent online pharmacies may put your health, or the health of your family, at risk. More informationA Glimpse at “Gluten-Free” Food Labeling
Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor. That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture. Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet. More informationFDA Warns About Stem Cell Claims
Stem cell therapies offer the potential to treat diseases or conditions for which few treatments exist. Stem cells, sometimes called the body’s “master cells,” are the precursor cells that develop into blood, brain, bones and all of your organs. Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases. But FDA is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful. More information

More Consumer Updates
For previously published Consumer Update articles that are Timely and easy-to-read and cover all FDA activities and regulated products. More information

Artículos en Español
Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable.
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Resources

Snowman at nightDevice Use Safety Tips
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. More informationFDA 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
Janet WoodcockHave a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity.
More informationTo read questions and answers, see MailBag.
Gus - SantaAnimal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information
Beth - Bunny Cat 

CVM Pet Facts
The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe.
More information

Five DogsCaution to Pet Owners – Pet Treats and Toys May Cause Problems for Your Pet
With the holiday season upon us, many pets will receive gifts such as pet treats and toys including chew toys. Each year FDA receives a small number of reports of adverse events associated with pet treats. Pet owners should be aware that occasionally, pet treats and chew toys may cause choking or blockage problems for their pets and may want to monitor their pets for signs of potential problems. More information
Fido

Take the “Oh No!” Out of Your and Your Pets’ Holiday “Ho-Ho-Ho!”
It’s the holiday time of year again. While you’re busy decorating, baking, wrapping gifts, and preparing your household for guests, remember to watch out for holiday temptations for your pets. Don’t let a pet disaster turn both your and your pets’ Holiday “Ho-Ho-Ho!” into a Holiday “Oh No!” More information

I QuitTobacco Products
The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. More informationTobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics. More information

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Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of the Food and Drug Administration (FDA). The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics.
More information

 

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food fact for consumers to keep you and your family safe. More information

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Latest Additions to SCVNews.com
1891 - Future First Lady Lou Henry (Hoover), 17, poses for photo at R.E. Nickel's Acton store [story]
Deputies from the Santa Clarita Valley Sheriff’s Station responded to a possible burglary call at a warehouse in the 29000 block of Avenue Sherman in Valencia Monday morning.
SCV Deputies Investigate Reported Valencia Warehouse Burglary
Tonight on SCV NewsBreak, a once-in-a-century solar experience took place Monday. Plus, on Saturday, dozens of people gathered in Newhall to celebrate the legacy of the old Saugus Speedway, its racers and its crew. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Monday, August 21, 2017
The 28th Annual Fine Art Show & Gala presented by the Santa Clarita Artists Association and the county of Los Angeles takes over Hart Hall on Saturday afternoon, October 14.
October 14: SCAA, County’s 28th Annual Art Classic at Hart Park
Organizers of the city of Santa Clarita's quarterly photo contest are now accepting entries for the fall 2017 competition.
City Opens Entries for Fall 2017 Photo Contest
The Santa Clarita Valley Boys & Girls Club invites everyone who shares a special connection with the club to the Alumni BBQ on Saturday afternoon, September 9.
September 9: Boys & Girls Club Alumni & Friends BBQ
Comedian and magician Fritz Coleman brings his stand-up show to Santa Clarita with an intimate, one-time performance at the Keyboard Galleria Music Center on Saturday, August 26.
August 26: Comic Fritz Coleman Stands Up at Keyboard Galleria
Deputies from the Santa Clarita Valley Sheriff's Station issued 38 traffic citations Friday and arrested a Newhall man on a parole violation warrant on Saturday.
Deputies Cite Speeders, Arrest Parolee
Lancaster JetHawks right-handed pitcher Jesus Tinoco has been named the California League Pitcher of the Week for August 14-20, 2017.
JetHawks’ Tinoco Named Cal League Pitcher of the Week
The Los Angeles Dodgers have acquired outfielder Curtis Granderson and cash considerations from the New York Mets in exchange for a player to be named later or cash considerations.
Dodgers Aqcuire Outfielder Curtis Granderson from Mets
The TMU Mustangs' women's volleyball home opener proved to be exactly what the doctor ordered as the hosts dispatched Lewis & Clark State College (ID) in straight sets 25-19, 25-22, 25-17.
Lady Mustangs Dispatch Lewis & Clark in Straight Sets
The Master's University's men's soccer team inaugurated their 2017 season with a 5-0 win over Northwest of Washington on Reese Field Saturday afternoon.
TMU Men’s Soccer Blanks Northwest in Season Opener
The Master’s University women’s soccer team’s 2017 record improved to 2-0 after beating the No. 8 ranked Northwest University Eagles 3-1 on Saturday morning at Reese Field.
TMU Women’s Soccer Team Grounds Eagles 3-1 Saturday
CalArtians Mathieu Libman (Film/Video BFA 19) and Aram Sarkisian (Film/Video BFA 17) are among the seven finalists for Student Academy Awards in the Animation category.
Two CalArtians Named 2017 Student Academy Awards Finalists
Western singer and songwriter John Zipperer headlines the next episode of "SCVTV Presents The OutWest Concert Series" at The MAIN in Old Town Newhall the evening of Friday, August 25.
August 25: John Zipperer Headlines ‘SCVTV Presents The OutWest Concert Series’
The Lancaster JetHawks clinched a franchise-record sixth consecutive winning season with their 71st victory, a 7-2 win over the Inland Empire 66ers, on Sunday afternoon at San Manuel Stadium.
JetHawks Sweep Sixers Sunday, Secure Winning Season
The Santa Clarita Valley Sheriff’s Station and the city of Santa Clarita launch the “Heads Up” campaign this week to combat distracted driving and increase pedestrian safety.
City, Sheriff’s Station Launch ‘Heads Up’ Safety Campaign
An 18-year-old man from Lancaster surrendered to the Santa Clarita Valley Sheriff’s Station’s Special Victims Unit Monday morning in connection with an alleged sexual assault earlier this month on College of the Canyons' Valencia campus.
Suspect Arrested in Alleged COC Sexual Assault
The Lancaster JetHawks scored seven runs in the fifth inning, propelling themselves to a 9-4 win over the Inland Empire 66ers on Saturday night at San Manuel Stadium.
Seven-Run Fifth Inning Carries JetHawks to Win Saturday
Hundreds of drivers were screened in a DUI checkpoint in Stevenson Ranch Friday night, but no arrests were made, CHP officials said.
CHP DUI Checkpoint Screens Hundreds of Drivers
1961 - CalArts grad (MFA '92) and marine biologist Stephen Hillenburg, creator of Spongebob SquarePants, born in Oklahoma; developed prototype for Spongebob while studying at CalArts in 1989. Estimated net worth in 2012: $90 million [story]
The Santa Clarita Public Library invites residents to view the total solar eclipse on Monday, August 21 at the Old Town Newhall Library starting at 10 a.m.
August 21: Solar Eclipse Viewing at Newhall Library
1967 - New Town of Valencia dedicated; homes sell for $25,000 [story]
1879 - Newhall civic leader Charles Henry Kingsburry born in Missouri [story]
Alerted by a concerned citizen Friday, Santa Clarita Valley Sheriff's Station deputies once again rescued dogs the owner left in a car with the windows rolled up and no water.
Deputies Break Window, Rescue Dogs Locked in Car
40 oz. to Freedom arrives in Santa Clarita as part of its anniversary tour at Concerts in the Park at Central Park on Saturday, August 19, with showtime at 7 p.m.
August 19: 40 Oz. to Freedom Rocks Central Park
Two local environmental groups filed a complaint in L.A. Superior Court Thursday regarding the approved plan to provide water to the Newhall Ranch development, set to break ground in 2018.
Environmental Groups File Complaint Against Newhall Ranch Water Plan
County Supervisor Kathryn Barger has provided $143,000 in funding to extend the season of youth and adult swim programs offered at the Castaic Aquatic Center through October 31.
Castaic Aquatic Center Programs Extended to October 31
Tonight on SCV NewsBreak, Los Angeles County firefighters and government leaders welcomed back the Super Scoopers Friday morning. Plus, the Old Town Newhall Library helped get the community ready for it as well by handing out free eclipse viewing glasses. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Friday, August 18, 2017
CalArts alumna Audrey Chan (Art MFA 07) will host a free, all-ages interactive arts workshop in Little Tokyo on Saturday and Sunday, August 19 and 20, as part of the Japanese American Cultural & Community Center’s 2017 Nisei Week activities.
August 19-20: Nisei Week Arts Workshop with CalArts Alum Audrey Chan
Habitat for Humanity SFV/SCV is honored to have received a $25,000 grant from the Disabled Veterans National Foundation, which will fund trauma workshops.
Habitat for Humanity Receives $25K Grant from Disabled Veterans
Here are agenda highlights for the next meeting of the Los Angeles County Board of Supervisors, set for Tuesday, August 22, starting at 9:30 a.m..
August 22: Board of Supervisors Meeting Agenda
Ashley Olivier, a student worker at the Santa Clarita Valley Sheriff's Station, summited Mt. Whitney with her dad, a lieutenant at LASD's Monterey Park station.
SCV Sheriff’s Station Student Worker, LASD Dad Top Mt. Whitney
Looking to enter the win column for the first time in 2017 on day two of the Summer Slam volleyball tournament, the TMU Mustangs squared off against 11th-ranked Eastern Oregon but lost in straight sets.
Mountaineers Spike Mustangs at Summer Slam
Caltrans has released "Rail and the California Economy," a research report investigating how the state’s vast passenger and freight rail system contribute to California’s economy, as well as an overview of opportunities for rail to address the state’s needs and challenges in the future.
New Report Details Rail Role in State Economy
The Master’s University women’s soccer team soared to a 7-0 victory over the visiting Eagles from Sierra Nevada College Thursday.
Lady Mustangs Soccer Win Opener 7-0