Patient Network News

In This Issue  Product Safety  Product Approvals  Recently Published Guidances  Announcements  Upcoming Public Meetings	Volume 1 | Number 3 | April 6, 2011 Product Safety FDA Warns Consumers to Stop Using Soladek Vitamin Solution FDA is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D. Greenstone Announces Voluntary Nationwide Recall Of Citalopram And Finasteride Due to Possible Mislabeling Greenstone LLC announced that it is voluntarily conducting a recall, to the patient level, of medicines with lot number FI0510058-A on the label. This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer. This is the only lot number being recalled and no other lots or markets are believed to be impacted. APP Pharmaceuticals Issues A Nationwide Voluntary Recall Of Irinotecan Hydrochloride Injection APP Pharmaceuticals, Inc., (APP) announced that it has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection, which is used for recurrent or progressive metastatic colorectal cancer. This recall is being conducted as a precautionary measure and there have been no reports to dates of adverse events related to the recalled products. Millar Instruments, Inc. Issues a Recall of Millar Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F Millar Instruments, Inc, Houston, Texas, is issuing a worldwide recall of 1,080 units of its Human Use High Injection Angiographic Catheter. The Angiographic Catheter, Models SPC-454D and SPC-454F, found to contain particulate debris within the catheter lumen, which potentially could result in embolization of foreign debris to tissues, vasculature, and organs, potentially causing myocardial infarction, stroke, limb ischemia, and /or death. Lilly Announces Important Action Regarding Recall of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits Eli Lilly and Company announced that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States. The Tri-ad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. Universal Nutrition Voluntarily Recalling Several Protein-Based Supplements Due To Possible Salmonella Contamination Universal Nutrition of New Brunswick, NJ is voluntarily recalling specific lot numbers for Gain Fast, LAVA, Real Gains, Super Whey Pro, Torrent, Ultra Mass 4500, Ultra Whey Pro and Uni-Syn because one ingredient, whey protein, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. For more product safety information, please visit our MedWatch website.  Product Approvals FDA approves new treatment for a type of late-stage skin cancer FDA approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age FDA approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older. FDA approves new device to treat aneurysms On April 6, 2011, FDA approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery. An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women. For information on drug approvals, please visit Drugs@FDA Recently Published Guidances Draft Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods The purpose of this guidance is to address testing procedures for Salmonella species (Salmonella spp.) in human foods and direct-human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render the food injurious to human health.   User Fee Waivers, Reductions, and Refunds for Drug and Biological Products This guidance provides recommendations to applicants regarding requests for waivers, refunds, and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and cosmetic Act for drugs, including biological drug products. This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993.   Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products This guidance is intended to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. FDA approves new device to treat brain aneurysms On April 6, 2011, FDA approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms (an aneurysm is a weak, enlarged area in an artery) without performing open surgery. An aneurysm is a weak, enlarged area in an artery (blood vessel). Over time, the force of normal blood pressure can cause it to rupture, which can be life-threatening and cause significant disability in survivors. The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm. Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women. Announcements FDA Issues Statement on Makena  On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.   Michigan heart-lung bypass machine manufacturer enters into consent decree  FDA announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers have signed a consent decree of permanent injunction.  The consent decree prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers and restricts sale of these systems to existing customers until TCVS complies with the FDA’s current Good Manufacturing Practice (cGMP) and Medical Device Reporting (MDR) requirements. FDA, EMA announce pilot for parallel assessment of Quality by Design applications  FDA and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.  Upcoming Public Meetings FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Please contact the "contact person" listed for each meeting for more information about how to submit comment, testimony or other information. Oncologic Drugs Advisory Committee Meeting Date:  April 12, 2011 Time:  8:00 a.m. to 5:00 p.m. Location:  FDA White Oak Campus, Building 31, The Great Room (Rm. 1503) White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland Contact:  Caleb Briggs, Pharm.D., Phone: 301-796-9001, E-mail: caleb.briggs@fda.hhs.gov   The committee will discuss supplemental New Drug Application (sNDA) 022334/S-009, trade name Afinitor (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corporation.    FDA/AdvaMed Medical Device and IVD Statistics Workshop Date:  April 13-14, 2011 Location:  The Gaylord National Hotel National Harbor, MD 20852  Contact:  Gregory Campbell, Phone: 301-796-5750, E-mail: greg.campbell@fda.hhs.gov   This conference, co-sponsored by FDA and AdvaMed Medical Technology Learning Institute, will discuss issues related to medical technology clinical studies.  Topics include patient reported outcomes and statistical analysis of postmarket studies.   CDER Small Business Assistance: Clinical Trials Forum Date:  April 21, 2011 Time:  9:00 a.m. to 4:45 p.m. Location:  FDA White Oak Campus, Building 31, Room 1503 - Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Contact:  CAPT Brenda Stodart, Phone: 301-796-3400, E-mail: CDERSmallBusiness@fda.hhs.gov   The Clinical Trials forum will provide small businesses with an opportunity to learn about various aspects of clinical trial design, both strategic and technical, from FDA experts in the field.   General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Date:  April 27, 2011 Time:  8:00 a.m. to 6:00 p.m. Location:  Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD Contact:  Margaret McCabe-Janicki, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993, Phone: 301-796-7029   The committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc.  The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.   Antiviral Drugs Advisory Committee Meeting Date:  April 27 and 28, 2011 Time:  8:00 a.m. to 5:00 p.m. Location:  FDA White Oak Campus, Building 31, The Great Room (Rm. 1503) White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland Contact:  Paul Tran, R.Ph., Phone: 301-796-9001, E-mail: paul.tran@fda.hhs.gov   On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.    On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.   Blood Products Advisory Committee Meeting Date:  April 28-29, 2011 Time:  April 28, 8:30 a.m. to 5:00 p.m.; April 29, 8:00 a.m. to 1:00 p.m. Location:  Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD Contact:  Bryan Emery or Rosanna Harvey, 1401 Rockville Pike, HFM-71, Rockville, MD 20852, Phone: 301-827-1277, E-mail: Bryan.Emery@fda.hhs.gov, E-mail: Rosanna.Harvey@fda.hhs.gov On April 28, 2011, in the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing. On April 29, 2011, in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services’ Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.   Risk Communication Advisory Committee Meeting Date:  May 5, 2011 Time:  8:00 a.m. to 5:00 p.m. Location:  Food and Drug Administration, 5630 Fishers Lane, Conference Room 1066, Rockville, MD 20857 Contact:  Lee L. Zwanziger, Designated Federal Official, 10993 New Hampshire Avenue, Building 32, Room 3278, Silver Spring, MD 20993, Phone: 301-796-9151, E-mail:  RCAC@fda.hhs.gov The committee will hear and discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of different channels for information dissemination, tracking how information is gathered and spread and thoughts on reaching less accessible target audiences.   Town Hall Discussion With the Director of CDRH and Other Senior Center Management Date:  May 5, 2011 Time:  8:00 a.m. - 12:00 noon EDT Location: Sheraton Orlando Downtown Hotel, 400 West Livingston Street Orlando, Florida 32801 Contact:  Susan Monahan Phone: 301-796-5661 E-mail: susan.monahan@fda.hhs.gov Dr. Jeffrey Shuren, the Director of CDRH, will describe CDRH’s Strategic Priorities for 2011. Members of the public will be given the opportunity to present comments to CDRH Senior Staff followed by Q&A session during which any member of the public may ask questions of the CDRH Senior Staff on any topic of interest.   Allergenic Products Advisory Committee Meeting Date:  May 12, 2011 Time:  8:00 a.m. to 3:30 p.m. Location:  Doubletree Hotel,  8120 Wisconsin Avenue, Bethesda, MD  20814 Contact:  Gail Dapolito or Jane Brown Phone: 301-827-0314, E-mail: gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov   The committee will receive updates and have discussion on the following topics:  (1) Structure and Activities of the Laboratory of Immunobiochemistry (the Laboratory), Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA; (2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by the Laboratory; (3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products; (4) environmental exposure chambers for phase III studies of allergenic products, and (5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory.   Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Date:  May 12, 2011 Time:  8:00 a.m. to 6:00 p.m. Location:  Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877 Contact:  Margaret McCabe-Janicki, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, Phone: 301-796-7029   The committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc.    Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Meeting Date:  May 17 and 18, 2011 Time:  8:00 a.m. to 5:00 p.m. – May 17; 8:00 a.m. to noon Location:  Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland Contact:  Diem-Kieu Ngo, Pharm.D., BCPS Phone: 301-796-9001, E-mail: diem.ngo@fda.hhs.gov   On May 17 and 18, 2011, the committees will review pertinent pharmacokinetic (how drugs are absorbed, distributed, used, and eliminated by the body), safety and efficacy data, and discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children less than 2 years of age.   Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products Date:  May 17-18, 2011 Time:  May 17, 8:30 a.m. to 5:00 p.m.; May 18, 8:00 a.m. to 11:30 p.m. Location:  The Universities at Shady Grove Conference Center, Building II, Multipurpose Room, 9630 Gudelsky Drive, Rockville, MD 20850 Contact:  Rhonda Dawson, FDA, Office of Blood Research & Review, Center for Biologics Evaluation and Research, 1401 Rockville Pike, HFM-302, Rockville, MD 20852, Phone: 301-827-6129, E-mail: rhonda.dawson@fda.hhs.gov   FDA, in cooperation with the National Heart, Lung and Blood Institute, and the Plasma Protein Therapeutics Association, are jointly co-sponsoring a public workshop on risk mitigation strategies to address procoagulant activity that may be present in some Immune Globulin Intravenous (Human) (IGIV) products.   FDA Workshop - Assuring the Safety and Effectiveness of Seizure, Cognitive Function, and TBI/Sports Concussion Diagnostic Devices DATE:  June 2 and 3, 2011 LOCATION:  Food and Drug Administration, White Oak Campus, 10903 New Hampshire Ave, Building 31, Silver Spring, MD 20993 The FDA is tentatively planning with the American Academy of Neurology, American Epilepsy Society, and National Academy of Neuropsychology a Workshop on Non-invasive Devices for Seizure Detection, Cognitive Evaluation, and Traumatic Brain Injury/Sports Concussion Assessment. Attendees will discuss approaches and endpoints for clinical studies for these devices and how the results should be conveyed to the users so that the devices may be used effectively.  Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Date:  June 29, 2011 Time:  8 a.m. to 6 p.m. Location:  Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD Contact:  Shanika Craig Phone: 301-796-6639   The committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex.   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.   RESOURCES Articles Please visit Articles of Interest to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals. Other Resources FDA MedWatch is now on Twitter!  Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter.  Follow us on Twitter to receive the MedWatch Safety Alerts: http://twitter.com/FDAMedWatch FDA Drug Info Rounds A series of training videos for practicing clinical and community pharmacists. FDA Patient Safety News FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products. 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.