January 30, 2013
PRODUCT SAFETY
Class
1 Recall: Vycor
Viewsite Brain Access System (VBAS) - Unidentified
Fiber Found on Device
Vycor Medical recalled its VBAS because an unidentified black fiber was found on
the device. This product may cause serious adverse health consequences,
including death. More information
Lactated Ringers and 5 Percent Dextrose Injection, USP,
1000 ML, Flexible Containers: Recall - Due to Non-Sterility
One confirmed customer report where a spore-like structured particulate,
consistent with mold, was noted in the solution. More information
Recall: Super Power - Undeclared Ingredient
Finished product of Super Power was tested and found to contain trace
amounts of sildenafil. More information
Drug Warning: Samsca (tolvaptan) - Potential Risk of Liver Injury
Large clinical trial findings of significant elevations of both ALT and
bilirubin. More information
Class I Recall: Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic
Viscosurgical Devices (OVD) - Cannulas May Leak or Detach From the Syringe
Bausch and Lomb notified heathcare professionals of a Class I recall of certain
Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2 percent
Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6
percent Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic
Viscosurgical Device. More information
Recall:
Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron
Supplement - Bottle May Contain Meclizine HCl 25 mg Tablets
Advance Pharmaceutical Inc. notified the public of a recall of one lot of
Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle
of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg tablets. The
lot of the Rugby Ferrous Sulfate is 12G468. More information
FDA Safety Communication: Metal-on-Metal Hip Implants - Updated Safety Recommendations
FDA notified healthcare professionals that it is providing updated safety
information and recommendations to patients and health care providers, based on
the FDA’s current assessment of metal-on-metal hip implants, including the
benefits and risks, the evaluation of the published literature, and the results
of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. 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 druginfo@fda.hhs.gov. Comunicaciones de la FDA
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
PRODUCT APPROVALS
FDA approves new orphan drug Kynamro to treat inherited cholesterol
disorder
FDA approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering
medications and diet to treat patients with a rare type of high cholesterol
called homozygous familial hypercholesterolemia (HoFH). More information
FDA approves three new drug treatments for type 2
diabetes
FDA approved three new related products for use with diet and exercise to improve
blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets,
Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin
and pioglitazone) tablets. More information
FDA approves Gleevec for children with acute lymphoblastic
leukemia
FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with
Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). More information
FDA approves over-the-counter Oxytrol for Women to treat overactive
bladder
FDA approved Oxytrol for Women, the first over-the-counter treatment for overactive
bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription
only. More information
FDA approves Exjade to remove excess iron in patients with genetic blood
disorder
FDA
expanded the approved use of Exjade (deferasirox) to treat patients
ages 10
years and older who have chronic iron overload resulting from a genetic
blood
disorder called non-transfusion-dependent thalassemia (NTDT). The FDA is
also authorizing marketing of FerriScan as an imaging companion
diagnostic for Exjade therapy in patients with NTDT. More information
FDA approves Botox to treat overactive bladder
FDA expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with
overactive bladder who cannot use or do not adequately respond to a class of
medications known as anticholinergics. More information
FDA approves new seasonal influenza vaccine made using novel technology
FDA approved Flublok, the first trivalent influenza vaccine made using an insect
virus (baculovirus) expression system and recombinant DNA technology. Flublok is
approved for the prevention of seasonal influenza in people 18 through 49 years
of age. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
OPPORTUNITIES FOR COMMENT / GUIDANCES
Comment Request: Smokeless Tobacco Product Warning Statements
FDA is establishing a public docket to obtain comments, supported by
scientific evidence, regarding what changes to the smokeless tobacco product
warnings, if any, would promote greater public understanding of the risks
associated with the use of smokeless tobacco products. Submit electronic or written comments by April 1, 2013. More information
Guidance for Industry and Food and Drug Administration Staff - Humanitarian Use
Device (HUD) Designations
Devices are eligible for HUD designation if they are designed to treat or
diagnose a disease or condition that affects or is manifested in fewer than
4,000 individuals in the United States per year. This guidance finalizes the draft guidance of the same title dated December
2011. More information
Comment Request: Food Labeling - Notification Procedures for Statements on
Dietary Supplements
FDA invites comments on the information collection provisions of the regulation
requiring manufacturers, packers, and distributors of dietary supplements to
notify us that they are marketing a dietary supplement product that bears on its
label or in its labeling a statement provided for in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). Submit either electronic or written comments on the collection of information by March
19, 2013. More information
Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments
FDA
will be holding a public hearing to obtain input on how to address
microbial contamination of patient preoperative skin preparation drug
products.Comments will be accepted until February 12, 2013. More information
ANNOUNCEMENTS
Flu and the FDA: An Interview With Margaret A. Hamburg, MD
Medscape spoke with Margaret A. Hamburg, MD, Commissioner of the US Food and
Drug Administration (FDA), about the FDA's efforts to address shortages and
other issues related to pharmacologic management of influenza. More information
Grant Funds: 2013 Assuring Radiation Protection
FDA is announcing the availability of grant funds for the support of the
Center for Devices and Radiological Health (CDRH) radiation protection program. More information
Consumer Update: Don’t Double Up on Acetaminophen
More than 600 medications, both prescription and over-the-counter (OTC), contain
the active ingredient acetaminophen to help relieve pain and reduce fever. Taken
carefully and correctly, these medicines can be safe and effective. But taking
too much acetaminophen can lead to severe liver damage. More information
Consumer Update: At FDA, Pharmacists Answer Your Call
From their offices in Silver Spring, Md., FDA
pharmacists answer thousands of calls to 1-888-INFO-FDA each year. More information
The Evolution, and Revolution, of Flu Vaccines
The
manufacturing of flu vaccines is a highly-orchestrated and complex
process. FDA and its parent, the U.S. Department of Health and Human
Services, have
long encouraged the development of new technologies for producing flu
vaccines. More information
UPCOMING MEETINGS
FDA
advisory committe 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.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
Public Hearing - Creating an Alternative Approval Pathway
for Certain Drugs Intended to Address Unmet Medical Need (Feb 4-5)
FDA is announcing a public hearing to obtain
input on a potential new pathway to expedite the development of drugs,
including biological products, for serious or life-threatening conditions that
would address an unmet medical need. More information
Public Hearing - Impact of Approved Drug Labeling on Chronic
Opioid Therapy (Feb 7-8)
To obtain information, particularly
scientific evidence, such as study data or peer-reviewed analyses, on issues
pertaining to the use of opioid drugs in the treatment of chronic pain. More information
Risk Communication Advisory Committee Meeting (Feb 12)
The Committee will discuss general factors in
risk communication about FDA regulated products, including approaches to avoid
message fatigue and related communication barriers such as prevention or
warning fatigue or inaccurate risk perception. More information
Medical Imaging Drugs Advisory Committee Meeting (Feb 14)
The committee will discuss new drug
application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine
injection), application submitted by Guerbet, LLC. More information
Neurological Devices Panel of the Medical Devices Advisory
Committee Meeting (Feb 22)
The committee will discuss, make
recommendations and vote on information regarding the premarket approval
application (PMA) for the NeuroPace RNS System sponsored by NeuroPace,
Inc. The RNS System is indicated for use as an adjunctive therapy in
reducing the frequency of seizures in individuals 18 years of age or older with
partial onset seizures from no more than two foci that are refractory to two or
more antiepileptic medications. More information
Public Workshop - Clinical Flow Cytometry in Hematologic Malignancies (Feb 25-26)
FDA is seeking input from academia,
Government, laboratorians, industry, clinicians, patients and other stakeholders
on the role of clinical flow cytometry in hematologic malignancies, in order to
develop a specific regulatory policy for this class of in vitro diagnostic
devices. More information
Public Workshop - Minimal Residual Disease (Feb 27)
FDA in cosponsorship with the American Society
of Clinical Oncology, is announcing a public workshop that will provide a forum
for discussion of extending the qualification of minimal residual disease (MRD)
detection as a prognostic biomarker to that of an efficacy/response biomarker
in evaluating new drugs for the treatment of chronic lymphocytic leukemia
(CLL). More information
Meeting - Science Board to the Food and Drug Administration (Feb 27)
The Science Board provides advice primarily to the Commissioner of Food and
Drugs and other appropriate officials on specific complex scientific and
technical issues important to the FDA and its mission, including emerging issues
within the scientific community. More information
Vaccines and Related Biological Products Advisory Committee Meeting (Feb 27)
The committee will meet in open session to discuss and make recommendations on
the selection of strains to be included in the influenza virus vaccine for the
2013-2014 influenza season More information
Public Workshop - Minimal Residual Disease (Mar 4)
FDA in cosponsorship with the American Society
of Clinical Oncology, is announcing a public workshop that will provide a forum
for discussion of extending the qualification of minimal residual disease (MRD)
detection as a prognostic biomarker to an efficacy/response biomarker in
evaluating new drugs for the treatment of acute myeloid leukemia (AML). More information
Reproductive Health Drugs and the Drug Safety and Risk
Management Advisory Committee Meeting (Mar 5)
The committees will discuss whether the benefit
of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning
and weakening of bones that increases the chance of having a broken bone)
outweighs a potential risk of cancer. More information
Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7)
The committee will discuss the new drug application (NDA) 204275 for
fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO
ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment
of airflow obstruction and for reducing exacerbations in patients with chronic
obstructive pulmonary disease. More information
Public Conference - Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not,
and What Should We Do About It? (Mar 20-21)
The conference purpose is to discuss, debate, and build consensus among stakeholders in
the pharmaceutical industry, academia, health care providers, patient groups,
and regulatory bodies on how best to detect and assess the severity, extent, and
likelihood of drug causation of liver injury and dysfunction in people using
drugs for any medical purpose. More information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information
RESOURCES
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
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
Medical Prouct Safety Network (Medsun)
Medsun improves FDA's understanding of problems with
the use of medical devices so that the FDA, healthcare facilities,
clinicians, and manufacturers can better address safety concerns. The
Medsun newsletter provides monthly updates about timely medical device
issues that may impact patient safety. More information