FDA Updates for Health Professionals
U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, product approvals, announcements, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers (July 16)
The FDA warned the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.
FDA is conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk of cancer.
FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall (July 13)
FDA required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination.
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury (July 13)
FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced.
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism (July 9)
FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers.
FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin (July 8)
FDA warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.
FDA held a call on July 8 to brief interested stakeholders. A replay of stakeholder call is available until August 7. To access the replay, you may dial 800-944-3336 (within the United States) or 203-369-3426 (for international callers).
FDA Public Health Alert: Que She Weight Loss Capsules Contain Potentially Harmful Ingredients (July 8)
FDA warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.
For more product safety information, please visit our MedWatch website.
PRODUCT APPROVALS:
Information on drug approvals, please visit Drugs@FDA.
ANNOUNCEMENTS:
Safe Use of Long-Acting Beta-Agonists (July 16)
FDA Drug Info Rounds pharmacists discuss the new recommendations in the drug labels of Long-Acting Beta-Agonists (LABAs), and provide ways pharmacists can help patients use LABAs safely in the treatment of asthma.
The Past, Present, and Future of FDA Human Drug Regulation
The Center for Drug Evaluation and Research has updated the popular continuing education program Drug Review and Related Activities in the United States and has renamed the updated program to reflect legislative changes and improved operations. The new title is The Past, Present, and Future of FDA Human Drug Regulation.
UPCOMING MEETINGS:
DATE: July 22-23, 2010
TIME: 8:00 a.m. - 4:30 p.m.
LOCATION: Marriott Inn and Conference Center University of Maryland, University College, 3501 University Blvd. East Adelphi, Maryland
CONTACT: Kristine T. Khuc, Pharm.D., Phone: 301-796-9015, E-mail:Kristine.Khuc@fda.hhs.gov
The committees will discuss Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics.
DATE: July 26-27, 2010
TIME: 8:00 a.m. - 5:30 p.m.
LOCATION: Crown Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910
CONTACTS: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209,
Silver Spring, MD 20993-0002, 301-796-1300.
FDA is announcing a public workshop jointly sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America (IDSA) regarding scientific and potential research issues in antibacterial drug resistance, rapid diagnostic device development for bacterial diseases, and antibacterial drug development.
Blood Products Advisory Committee Meeting
DATE: July 26-27, 2010
TIME: July 26 from 8:00 a.m. -5:30 p.m. and July 27 from 8:00 a.m. to approximately 1:00 p.m.
LOCATION: Hilton Washington DC/North 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Bryan Emery or Pearline K. Muckelvene, phone: 301-827-1295 and e-mail:Bryan.Emery@fda.hhs.gov or email: pearline.muckelvene@fda.hhs.gov
On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. On July 27, the Committee will discuss blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval.
Orthopaedic and Rehabilitation Devices Panel Meeting
DATE: July 27, 2010
TIME: 8:00 a.m. – 6:00 p.m.
LOCATION: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD
CONTACT: Tracy Phillips, Center for Devices and Rad. Health, FDA, 301-796-6150
The panel will discuss premarket approval application for the AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP-2 Matrix is used for posterolateral fusion treatment of single level lumbar (L2–S1) degenerative disc disease.
Risk Evaluation and Mitigation Strategy (REMS) Public Meeting
DATE: July 27-28, 2010
TIME: 8:30 a.m. - 4:30 p.m.
LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, Maryland 20993
CONTACTS: Kristen Everett, Center for Drug Evaluation and Research, Food and Drug Administration, phone 301-796-0453 or e-mail REMSpublicmeeting@fda.hhs.gov at least 7 days before the meeting.
The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs.
Cardiovascular and Renal Drug Advisory Committee Meeting
DATE: July 28, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: University of Maryland Marriott Conference Centers, 3501 University Blvd, East Adelphi, MD 20783
CONTACTS: Elaine Ferguson, Center for Drug Evaluation and Research, Food and Drug Administration, phone 301-796-9001, e-mail: Elaine.Ferguson@fda.hhs.gov
The committee will provide advice on new drug application (NDA) 22-433, ticagrelor tablets, 90 milligrams, manufactured by AstraZeneca LP, for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent with blockages in the blood vessels that supply the heart).
Cardiovascular and Renal Drug Advisory Committee Meeting
DATE: July 29, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: University of Maryland Marriott Conference Centers, 3501 University Blvd, East Adelphi, MD 20783
CONTACTS: Elaine Ferguson, Center for Drug Evaluation and Research, Food and Drug Administration, phone 301-796-9001, e-mail: Elaine.Ferguson@fda.hhs.gov
The committee will discuss Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by FDA to Pfizer, to include assessment of a hemodynamic endpoint. An area of particular interest will be what the appropriate study endpoint should be in patients with PAH unable to perform exercise testing. The discussion will help the agency determine what studies to request for products intended to treat pediatric PAH.
Ophthalmic Devices Panel Meeting
DATE: July 30, 2010
TIME: 8:00 a.m. - 6:00 p.m.
LOCATION: Holiday Inn, Ballroom 2, Montgomery Village Ave., Gaithersburg, MD
CONTACTS: James Engles, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1566, Silver Spring, MD 20993–0002
The committee will discuss, make, recommendations, and vote on a premarket approval application for the Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS–100 L/R, sponsored by Glaukos Corp. The device is indicated for use in conjunction with cataract
surgery for the reduction of intraocular pressure (IOP) in subjects with mild
to moderate open-angle glaucoma currently treated with ocular hypotensive
medication.
Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development
DATE: Aug 2-3, 2010
TIME: 8:30 a.m. - 5:30 p.m.
LOCATION: Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910
CONTACTS: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, phone 301-796-1300.
FDA is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug.
Peripheral and Central Nervous System Drug Advisory Committee Meeting
DATE: Aug 11, 2010
TIME: 8:00 a.m. - 5:00 p.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland
CONTACTS: Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Administration, phone 301-796-9001, E-mail: diem.ngo@fda.hhs.gov
The committee will discuss new drug application (NDA) 22-345, with the proposed trade name POTIGA (ezogabine) Tablets, by Valeant Pharmaceuticals North America. The proposed indication for this new drug product is adjunctive therapy in patients with partial-onset seizures.
2010 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference
DATE: September 13 – 16, 2010
TIME: 8:00 a.m. – 5:00 p.m.
LOCATION: The Renaissance Hotel, 999 9th Street, NW, Washington, D.C.
CONTACT: Wanda Neal, Phone: 301-656-5900, ext. 111, E-mail: Neal@pda.org
FDA speakers will provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance.
Drug Safety and Risk Management Advisory Committee Meeting Announcement
DATE: September 14, 2010
TIME: 8:00 a.m. – 5:00 p.m.
LOCATION: The Marriott Inn and Conference Center/University of Maryland, University College (UMUC), The Ballrooms, 3501 University Blvd. East, Adelphi, Maryland
CONTACT: Elaine Ferguson, c/o Christine Shipe, Phone: 301-796-9001, E-mail:Elaine.Ferguson@fda.hhs.gov
The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. 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 dextromethorphan in response to the increased incidence of abuse, especially among adolescents.
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.
Videos
MedWatch Safety Information Resources for Busy Physicians
A video discussing Medwatch Safety Alerts
Other Resources
FDA Drug Info Rounds
A series of training videos for practicing clinical and community pharmacists.
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.
If you have any questions, you may contact me at the email listed below. Thank you for your continued support of FDA activities.
Best regards,
Heidi C. Marchand, PharmD
Office of Special Health Issues
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
(301) 796-8460
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