U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, 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.
Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result (Apr 24)With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). The affected lot numbers are 163176 and 163177.
Aliskiren-containing Medications: Drug Safety Communication - New Warning and Contraindication (Apr 20)FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment.
Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians (Apr 20)FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012. The agency has also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.
U.S. Marshals seize ultrasound gel product at a New Jersey company (Apr 18)U.S. Marshals, acting at the request of FDA, have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained dangerous bacteria.
FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”) (Apr 18)FDA reminds patients, caregivers, and healthcare professionals of the importance of appropriate storage, use, application, and disposal of fentanyl patches (including Duragesic and generic products) to prevent potential life-threatening harm from accidental exposure to the active ingredient, fentanyl.
Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume (Apr 17)Hospira, Inc., announced it is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source PlasmaUnder this rulemaking, FDA is consolidating the regulations related to labeling blood and blood components. Fax written comments on the collection of information by May 25, 2012.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring CommitteesThe guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study and how such committees should operate. Fax written comments on the collection of information by May 21, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot StudyThis notice solicits comments on the survey entitled “Medical Device Decision Analysis: A Risk-Tolerance Pilot Study.” Submit either electronic or written comments on the collection of information by June 18, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationThis notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a “small business” and pay certain medical device user fees at reduced rates. Submit either electronic or written comments on the collection of information by June 18, 2012.
Proposed Collection; Comment Request; Financial Disclosure by Clinical InvestigatorsThis notice solicits comments on information collection on financial disclosure by clinical investigators. Submit either electronic or written comments on the collection of information by May 29, 2012.
Comment Request; Experimental Study of Graphic Cigarette Warning Labels This notice solicits comments on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). Submit either electronic or written comments on the collection of information by May 29, 2012.
Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Submit either electronic or written comments on the collection of information by May 22, 2012.
Draft Guidance for Industry: Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program
This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the FD&C Act. Submit either electronic or written comments on the draft guidance by May 14, 2012.
Draft Guidance: Classifying Significant Postmarketing Drug Safety Issues This draft guidance describes FDA's current approach to classifying a significant postmarket drug safety issue as a “priority” tracked safety issue (TSI) or a “standard” TSI, with the capability of elevating some priority TSIs to an “emergency” status. Submit either electronic or written comments on the draft guidance by May 8, 2012.
Draft Guidance: Drug Safety Information -- FDA's Communication to the Public
This draft guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors that influence when the information is communicated. Submit either electronic or written comments on the draft guidance by May 8, 2012.
Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products
This draft guidance provides the pharmaceutical industry with CDER's current thinking on the potential human health risks associated with exposure to DBP and DEHP. Submit either electronic or written comments on the draft guidance by May 31, 2012.
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription DrugsSubmit either electronic or written requests for oral presentations and comments by March 9, 2012. Either electronic or written comments will be accepted after the hearing until May 7, 2012.
Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage: Draft Guidance Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
National Take Back Initiative (Apr 23)The Drug Enforcement Administration (DEA) has scheduled another National Prescription Drug Take-Back Day which will take place on Saturday, April 28, 2012, from 10:00 a.m. to 2:00 p.m.
FDA strengthens international collaboration to ensure quality, safety of imported products (Apr 23)FDA Commissioner Margaret A. Hamburg, M.D. released the agency’s “Global Engagement Report,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
Advances in FDA's Safety Program for Marketed Drugs (Apr 23)In this report, FDA describes the actions the Agency’s Center for Drug Evaluation and Research (CDER) has taken in recent years to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions.
Report: FDA strengthens monitoring of post-approval drug safety (Apr 21)A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in FDA’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER).
FDA issues draft guidance on nanotechnology (Apr 20)Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued by FDA.
Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre el riesgo de coágulos de sangre en las mujeres que toman pastillas anticonceptivas que contienen drospirenona- Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas- Comunicado de la FDA sobre la seguridad de los medicamentos: Cambios importantes en la etiqueta de seguridad de los medicamentos para reducir el colesterol conocidos como estatinas - Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 25-26)
FDA/Xavier University Medical Device Conference (May 1-4)
Pediatric Advisory Committee Meeting (May 7-8)
Arthritis Advisory Committee Meeting (May 8)
Arthritis Advisory Committee Meeting (May 9)
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (May 10)
Antiviral Drugs Advisory Committee Meeting (May 10)
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (May 10-11)
Antiviral Drugs Advisory Committee Meeting (May 11)
Public Hearing on Draft Guidances Relating to the Development of Biosimilar Products (May 11)
Workshop on Natural History Studies of Rare Diseases (May 16-17)
FDA Working with Patients to Explore Benefit/Risk: Opportunities & Challenges (May 18)
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (May 24)
Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 24)
Scientific Workshop on the Assessment of Analgesic Treatment of Chronic Pain (May 30-31)
Gastrointestinal Drugs Advisory Committee Meeting (May 31)
Regulation of Pharmaceuticals: A Global Perspective (Jun 6-8)
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 21)
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 27-28)
Please visit FDA’s Advisory Committee page (http://www.fda.gov/
The Clinical Investigator's CME Program: Transforming a Clinician Into an Investigator: What Does It Take?Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today.
Statins: The Story Behind the Label Changes
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
Please visit Articles of Interest (http://www.fda.gov/
What To Do About Misleading Drug AdsA video discussing FDA's Bad Ad Program Featuring Michael Sauers, Team Leader for FDAs Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research.
FDA Drug Safety Podcasts Podcasts
FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone (Apr 12)
Please visit Articles of Interest (http://www.fda.gov/
MedWatch Safety Information Resources for Busy Physicians
A video discussing Medwatch Safety Alerts
New and Generic Drug ApprovalsMedication Guides2011 Novel New Drugs
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
FDA's China Offices Focus on Product Safety
FDA and ISMP Work to Prevent Medication Errors
Less Risky Tobacco Product? Only if the Science Says So
What Are You Smoking (or Chewing or Inhaling)?
FDA Continues to Study BPA
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff. FDA Voice is a new forum and through upcoming blog posts you will find news, background, announcements and other information about the work done at the FDA on behalf of the American public.
- Making a Difference: Innovation Pathway and Entrepreneurs in Residence (Apr 10)
FDA MedWatch 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
For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.
MedWatch Safety Alerts for Human Medical Products
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
FDA Drug Info Rounds
A series of training videos for practicing clinical and community pharmacists.
Device 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.
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.
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.
Office of Special Health Issues
Food and Drug Administration