This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.
Volume 3 | Number 10 | May 15, 2013
Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.1 Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug). More information
FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop FDA is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection. FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed FDA that it is recalling sterile products and is in the process of notifying customers. More information
Recall: Xymogen identifies allergen in dietary supplement artriphen in oversight by third-party manufacturer Nutraceutical company Xymogen in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk. People who have an allergy or severe sensitivity to either allergen run the risk of serious or life-threatening allergic reaction if they consume this product. Although there have been no reported allergic reactions or any adverse events in connection with the product to date, consumers are urged to return this product for a full refund. More information
Drug Safety Communication: Potential Medication Errors Resulting in Name Confusion for Kadcyla FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients. More information
Voluntary Recall: American Lifestyle Vicerex Capsules and Black Ant Capsules Due to Undeclared Active Ingredients American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. More information
Voluntary Recall: Beamonstar Products SexVoltz, Velextra, and Amerect Due to Undeclared Active Ingredients BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563, Amerect SKU’s 626570619031, 626570619598 capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs. These undeclared active ingredients poses a threat to consumers because tadalafil 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. BeaMonstar Products has not received any reports of adverse events to date related to this recall. More information
Voluntary Recall: 21 Lots of Piperacillin and Tazobactam for Injection Due to Possibility of Precipitation/Crystallization in IV Bag or IV Line Upon Reconstitution Apotex Corp. announced that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution. Hospira has stated that administration of precipitated Piperacillin / Tazobactam in an IV bag or IV line may result in local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis (because the precipitate was visible, its particles may be large enough to cause these adverse events). In addition, the precipitation of the drug may not allow delivering a needed therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate treatment of the targeted infection. This could result in adverse health consequences that could range from transient and minor impairment or complaints to permanent impairment of a body function or permanent damage to a body structure. Hospira has not received any reports of adverse events related to this recall. More information
Hospira Inc., GemStar Infusion System - Damage from Battery Leakage The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. Power can be lost when the pump loses contact with the batteries, or when components on the Middle Printed Wire Assembly (PWA) fail, or when the Middle PWA does not receive appropriate signals from elsewhere in the pump. Loss of contact can be due to a mechanical disconnect at either the positive or negative battery terminal. Inappropriate or missing input signals can be due to contamination, corrosion damage, electronic defects or keypad problems disrupting turn on/turn off signals. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en firstname.lastname@example.org. Comunicaciones de la FDA
For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.
FDA 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:
Desmopressin Acetate Injection (DDAVP)
Fluphenazine Hydrochloride Injection
Drugs to be Discontinued Announced During Past 2 Weeks:
FDA approves new drug for advanced prostate cancer FDA approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.More information
FDA approves first companion diagnostic to detect gene mutation associated with non-small cell lung cancers (NSCLC) and expands use for Tarceva (erlotinib) as a first-line treatment for patients with metastatic NSCLC FDA approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of NSCLCs. The test is being approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the body (metastasized) and who have certain mutations in the EGFR gene. Lung cancer is the leading cause of cancer-related death among men and women. According to the National Cancer Institute, there will be an estimated 228,190 new cases of lung cancer this year, and 159,480 deaths. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. More information
FDA approves Nymalize—first nimpdipine oral solution for use in certain brain hemorrhage patients FDA approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule. Subarachnoid hemorrhage is serious, life threatening bleeding that occurs in the subarachnoid space – the area between the brain and the thin tissues that cover the brain. Nimodipine is a medication given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage. More information
FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease FDA approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.More information
Perclose ProGlide Suture-Mediated Closure System (ProGlide AMC) - P960043/S080 FDA approved Perclose ProGlide Suture-Mediated Closure (ProGlide SMC) System, which is designed to deliver a single monofilament polypropylene suture to close a femoral artery (a major artery in the thigh) puncture site following diagnostic or interventional catheterization procedures. The Perclose ProGlide SMC System is used to deliver a suture to close the femoral artery site. It is composed of a plunger, handle, guide, and sheath. The ProGlide SMC System tracks over a standard four-tenths (0.4) of an inch (or smaller) guidewire. More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules. Comments are due by May 16, 2013. More information
Request for Comments: Tobacco Product Manufacturing Process Docket FDA is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies' recommendations and to share information that will improve FDA's understanding of the tobacco industry and its manufacturing operations. Comments are due by May 20, 2013.More information
Request for Comments: International Consortium of Cardiovascular Registries and Public Meeting FDA is holding a public meeting entitled “International Consortium of Cardiovascular Registries.” The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The meeting will be available via webcast and comments are due by May 22, 2013. More information
Request for Comments: An Evaluation of the Prescription Drug User Fee Act Workload Adjuster FDA is announcing an opportunity for public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent consulting firm. This assessment was conducted to fulfill FDA performance commitments made as part of the fifth authorization of PDUFA in section XV, “Improving FDA Performance Management,” subsection B, which was reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Comments are due by June 5, 2013. More information
Request for Comments: Recommendations for Labeling Medical Products to Inform Users the Product or Product Container Is Not Made With Natural Rubber Latex The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container. FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Comments are due by June 10, 2013. More information
Request for Comments: Infant Formula - The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements FDA is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. Comments are due by July 1, 2013. More information
Request for Comments: Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application - Questions and Answers This draft guidance is being issued consistent with FDA's good guidance practices regulation. The draft guidance, when finalized, will represent the Agency's current thinking on charging for an investigational drug under an IND. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. Comments are due by July 8, 2013. More information
Request for Comments: Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions. Comments are due by July 8, 2013. More information
Request for Comments: Center for Drug Evaluation and Research Medical Policy Council FDA is requesting public suggestions, recommendations, and comments for topics (including scientific, clinical, regulatory, or other topics) on existing or novel medical policy issues that may warrant consideration by the Council. Comments should describe the following: (1) The medical policy issue recommended for discussion, (2) the rationale for doing so (e.g., clarifying previous advice or precedents, reconciling apparently differing perspectives within CDER or between CDER and regulated industry), (3) recommendations on how the medical policy issue could be addressed or implemented; and (4) existing policy documents (e.g., final guidance) relevant to the medical policy issue. Comments are due by July 16, 2013. More information
Request for Comments: Reclassification of Ultraviolet Lamps for Tanning Henceforth To Be Known as Sunlamp Products FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. Comments are due by August 7, 2013. More information
Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information
FDA issues proposal to increase consumer awareness of tanning bed risk FDA issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices. According to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin cancer, in those who have been exposed to ultraviolet radiation from indoor tanning, and the risk increases with each use. The proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences. The order would reclassify sunlamp products from a low risk device (class I) to a moderate risk device (class II). More information
FDA releases new tool to help prevent intentional food contamination FDA has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities. FDA does not require food facilities to implement food defense plans, but many facilities have voluntarily put such plans into place to safeguard their products. More information
FDA Has Updated its Obesity Treatment Devices Web Page FDA updated its Obesity Treatment Devices Web Page with clear information about obesity treatment devices to help patients and health care providers make appropriate decisions for treating this condition. This webpage provides information about the types of obesity treatment devices, FDA-approved obesity treatment devices, FDA activities related to obesity treatment devices, and reporting obesity treatment device problems. More information
Track Our Success as We Implement New Law, by Leslie Kux, Assistant Commissioner for Policy, and Malcom Bertoni, Assistant Commissioner for Planning As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress. FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children. To read the rest of this blog, see FDA Voice Blog, May 15, 2013.
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.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Dates: May 21-22, 2013 The committee will discuss and make recommendations regarding the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. The class III shortwave diathermy is a device that applies electromagnetic energy to the body in a radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues. More information
Peripheral and Central Nervous System Drugs Advisory CommitteeMeeting Date: May 22, 2013 The committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance. More information
2013 Medical Countermeasures Initiative Regulatory Science Symposium Dates: May 29-31, 2013 The symposium is intended to provide a forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory science as it applies to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure-related scientific progress and accomplishments. More information
Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Dates: June 5-6, 2013 The committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline. More information
Public Meeting: FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices Dates: June 11-12, 2013 The purpose of the meeting is to present, discuss and receive input on an FDA library of models and data relevant to medical devices and to discuss a strategy to assess the credibility of computer models used to evaluate medical devices. More information
Public Conference: Redefining the "C" in CGMP: Creating, Implementing, and Sustaining a Culture of Quality Pharmaceutical Quality Sustem (ICH Q10) Dates: June 11-13, 2013 The conference will span 3 days and is dedicated to teaching the principles of CGMP, reaping the benefits that come from establishing and maintaining a state of control, implementing continual improvement, enhancing regulatory compliance, and meeting quality objectives every day. More information
Public Meeting: 510(k) Device Modifications - Deciding When To Submit a 510(k) for a Change to an Existing Device Date: June 13, 2013 FDA is holding this meeting to obtain information on its interpretation of the 510(k) device modifications regulations, and specifically, deciding when a 510(k) should be submitted for a change to a 510(k)-cleared device. More information
Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Date: June 13, 2013 The committee will discuss and make recommendations regarding the possible reclassification of influenza detection devices, currently regulated as class I. The committee's discussion will involve making recommendations regarding regulatory classification to either confirm class I or reclassify these devices into class II with special controls. The committee will address issues such as device performance and public health impact to determine whether special controls are needed to ensure the safety and effectiveness of these tests through their total product life cycle. The proposed special controls will be discussed to support the possible reclassification. More information
Public Meeting: HIV Patient-Focused Drug Development and HIV Cure Research Date: June 14, 2013 As part of the Patient-Focused Drug Development initiative, intended to enhance patient input, FDA will hold a public meeting on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. FDA is interested in obtaining patient input on the impact of HIV on daily life and currently available therapies to treat the condition (topic 1), and patients’ views on issues related to HIV cure research (topic 2). More information
Public Hearing: Generic Drug User Fee Amendments of 2012 and Regulatory Science Initiatives Date: June 21, 2013 In July 2012, Congress passed GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and to reduce costs to industry. To support this goal, FDA agreed in the GDUFA commitment letter to the FY 2013 Regulatory Science Plan, and to consult with industry and the public in order to create an annual list of regulatory science initiatives specific to research on generic drugs for each subsequent year covered by GDUFA. The purpose of the public meeting is to provide a forum for the public to provide recommendations to FDA related to regulatory science initiatives in generic drug research. More information
Public Workshop: The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women Dates: June 24-25, 2013 CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The CDRH HoW program seeks to bring together industry, clinicians, researchers, academia, government agencies, and patient/advocacy groups in an effort to: (1) Highlight device-specific clinical Study recruitment and retention strategies; (2) improve analysis and communication of sex-specific findings to providers and patients; (3) develop a priority research road map for the HoW device ecosystem. The workshop focus will be device- and disease-specific, patient centered, and action oriented. More information
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory CommitteeMeeting Date: June 27, 2013 In the morning, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. In the afternoon session the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. More information
Anesthetic and Analgesic Drug Products Advisory Committee Meeting Date: July 18, 2013 The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium. More information
Dental Products Panel of the Medical Devices Advisory CommitteeMeeting Date: July 18, 2013 The committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. More information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Date: July 24-25, 2013 The committee on July 24, 2013, will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. More information
Please 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.
Eight Tips for Using Over-the-Counter Cough and Cold Products in Children 1. Do not give children medications labeled only for adults. 2. Talk to your health care professional, such as your doctor or pharmacist, if you have any questions about using cough or cold medicines in children. 3. Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children. 4. Check the "active ingredients" section of the "Drug Facts" label of the medicines that you choose. This section will help you understand what symptoms the active ingredients in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient, such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever and fever reducer. 5. Be very careful if you are giving more than one medicine to a child. Make sure the medicines do not have the same type of active ingredients. For example, do not give a child more than one medicine that has a decongestant. If you use two medicines that have the same or similar active ingredients, your child could be harmed by getting too much of an ingredient. 6. Carefully follow the directions for how to use the medicine in the "Drug Facts" part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or other health care professional. Overuse or misuse of these products can lead to serious and potentially life-threatening side effects, such as rapid heartbeat, drowsiness, breathing problems, and seizures. 7. Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines. 8. Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child's symptoms, such as runny nose, congestion, fever, and aches. They do not shorten the length of time your child is sick.
Keep Listeria Out of Your Kitchen If you eat food contaminated with bacteria called Listeria, you could get so sick that you have to be hospitalized. And for certain vulnerable people, the illness could be fatal. Contaminated food can bring Listeria into the home. Unlike most bacteria, Listeria germs can grow and spread in the refrigerator. So if you unknowingly refrigerate Listeria-contaminated food, the germs not only multiply at the cool temperature, they could contaminate your refrigerator and spread to other foods there, increasing the likelihood that you and your family will become sick. More information
FDA to Investigate Added Caffeine FDA has announced that, in response to a trend in which caffeine is being added to a growing number of products, the agency will investigate the safety of caffeine in food products, particularly its effects on children and adolescents. Michael R. Taylor, deputy commissioner for foods and veterinary medicine at FDA, answers questions about his concerns and possible FDA actions.
Q: The announcement comes just as Wrigley's (a subsidiary of Mars) is promoting a new pack of gum with eight pieces, each containing as much caffeine as half a cup of coffee. Is the timing coincidental? A: The gum is just one more unfortunate example of the trend to add caffeine to food. Our concern is about caffeine appearing in a range of new products, including ones that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact. Complete answer to this question and more.
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. More information
FDA warns consumers about potential health risk with Juices Incorporated juice products FDA is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.More information
Food Allergies: What You Need to Know Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms,some food allergies can cause severe reactions, and may even be life-threatening. There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are important measures to prevent serious health consequences. More information
FDA's Role in Regulating Safety of GE Foods Foods from genetically engineered organisms, also known as biotech foods and referred to by some as food from genetically modified organisms (GMOs), have been in our food supply for about 20 years. Genetic engineering refers to certain methods that scientists use to introduce new traits or characteristics to an organism. For example, plants may be genetically engineered to produce characteristics that enhance the growth or nutritional value of food crops. Using a science-based approach, the Food and Drug Administration (FDA) regulates foods and ingredients made from genetically engineered plants to help ensure that they are safe to eat. More information
Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of 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 facts for consumers to keep you and your family safe. More information
Salmonella, Feeder Rodents, and Pet Reptiles and Amphibians – Tips You Should Know to Prevent Infection You may be one of the many Americans who own a pet reptile or amphibian. Reptiles—corn snakes, iguanas, and red-eared sliders, and amphibians, frogs and toads, to name a few—are unique creatures and can make for interesting pets. But pet reptiles and amphibians carry some risks to their owners, such as the potential for Salmonella infection. Both the reptiles and amphibians themselves, as well as the feeder rodents fed to some reptiles or amphibians can be sources of Salmonella infection for people. What are feeder rodents? What are the symptoms of salmoneliosis in people? Answers to these questions and more.
Understanding FDA Regulation of Pet Food FDA regulates that can of cat food, bag of dog food, or box of dog treats or snacks in your pantry. The FDA’s regulation of pet food is similar to that for other animal foods. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. In addition, canned pet foods must be processed in conformance with the low acid canned food regulations to ensure the pet food is free of viable microorganisms. More information
Animal 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
CVM Pet Facts The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information
Have 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 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
healthfinder.gov Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information
FDA Voice Blog FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements, and other information about the work done at the FDA on behalf of the American public. More information
Tobacco 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