FDA Consumer Health Information Updates
FDA Consumer Health Information Updates
Older adults are at higher risk for drug interactions. The U.S. Food and Drug Administration (FDA) offers tips to help these adults stay safe.
Posted: June 5, 2014, 11:00 am
FDA warns consumers about undeclared drugs found in weight loss pills, a sexual enhancement product, and pain relief pills.
Posted: May 29, 2014, 2:50 pm
To help protect consumers and inform them about the risks of indoor tanning, FDA is strengthening its regulation of sunlamp products and UV lamps and requiring that sunlamp products carry a visible, black box warning stating that sunlamp products should not be used on people under 18 years of age.
Posted: May 29, 2014, 1:00 pm
May is Hepatitis Awareness Month, a fitting time to focus on liver health. Medications pose a potential danger and have been responsible for drug-induced liver injuries. FDA is working to prevent those injuries.
Posted: May 28, 2014, 1:00 pm
May is National Lupus Awareness Month, a time to think about lupus and the challenges it presents to patients. Learn about this chronic, autoimmune disease and the promise of future therapies.
Posted: May 27, 2014, 1:00 pm
Obstructive sleep apnea has been linked to high blood pressure, heart attacks, strokes, car accidents, work-related accidents and depression. Learn about this disorder and how to treat it.
Posted: May 22, 2014, 1:00 pm
Science is finding new ways to attack cancer on different fronts. Since 2011, FDA has approved five drugs for melanoma and other skin cancers, giving patients more specialized tools, better treatment, better outcomes and a longer life.
Posted: May 22, 2014, 1:00 pm
You may know that the FDA works to keep foods and drugs safe for you and your family, but you may not realize the agency does much the same for your pets. Learn how, and what you can do to help.
Posted: May 21, 2014, 1:00 pm
May is Healthy Vision month, and a good time to examine the facts-and fiction-surrounding healthy vision. Take a look at these common statements about eye safety to find out: Fact or fiction?
Posted: May 20, 2014, 12:00 pm
This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.
Posted: May 19, 2014, 5:30 pm
Some people use high-intensity sweeteners as a substitute for table sugar. There will soon be a new one available to U.S. consumers. FDA has approved advantame, which is 20,000 times sweeter than sugar.
Posted: May 19, 2014, 1:00 pm
FDA is spearheading use of technology to aid in the fight against outbreaks of foodborne illnesses by identifying the DNA fingerprint left by disease-causing bacteria.
Posted: May 14, 2014, 2:16 pm
According to an FDA review, further investigation is needed on the long-term risks and benefits of bisphosphonates, drugs used to treat osteoporosis.
Posted: May 12, 2014, 4:00 pm
FDA monitors compliance with federal tobacco laws through surveillance, inspections, and investigations. Help FDA in your community by reporting potential violations of the law.
Posted: May 9, 2014, 11:00 am
Mother’s Day is May 11, an exciting time for new moms. But moms (and dads) of babies 12 months and younger can also have some worries. FDA medical officers offer health suggestions
Posted: May 8, 2014, 12:00 pm
Consumers have more options than ever for relief of allergy symptoms and treatment of allergic diseases in the form of FDA-approved medications. Learn more about these medications, including three newly approved sublingual (under the tongue) prescription medications to treat hay fever caused by certain grass pollens and short ragweed pollen.
Posted: May 7, 2014, 12:00 pm
Scientific evidence shows that aspirin can prevent heart attack or stroke in some people but not in everyone. And it can cause unwanted side effects. Where do you fit in?
Posted: May 5, 2014, 11:00 am
High blood pressure is called the 'silent killer' because it has no symptoms until it causes major damage. A number of FDA-approved drugs, along with lifestyle changes, can help treat this condition
Posted: May 1, 2014, 11:00 am
Can autism be cured? Are there therapies that can help? Learn about FDA's role in seeing to it that claims for treating autism are backed by reliable proof of safety and effectiveness.
Posted: April 25, 2014, 11:00 am
Tobacco use is the single largest preventable cause of disease and death in the United States, but can you recognize a tobacco product? Learn more about the array of new tobacco products on the market, many of which look very different from the traditional products you may know about.
Posted: April 24, 2014, 12:00 pm
What's New: Vaccines, Blood & Biologics RSS Feed
Documents recently posted on the CBER Web Site
Posted: June 5, 2014, 5:39 pm
Posted: June 5, 2014, 5:06 pm
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Information updated through May 31, 2014
Posted: June 3, 2014, 7:36 pm
Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010
Posted: May 27, 2014, 2:21 pm
Vaccine lot release information updated on 1/20/2010.
Posted: May 15, 2014, 1:20 pm
Information updated through April 30, 2014
Posted: May 13, 2014, 12:10 pm
Information updated through April 30, 2014
Posted: May 13, 2014, 12:07 pm
Posted: May 9, 2014, 3:15 pm
Food and Drug Adminstration (FDA): CDRHNew
Items added to the FDA's Center for Devices and Radiological Health website within the last month.
Materials posted for June 6, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: June 4, 2014, 4:00 am
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.
Posted: June 3, 2014, 4:00 am
The FDA is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of...
Posted: June 3, 2014, 4:00 am
Starting with the medical residency graduating classes of 2014, the American Board of Radiology (ABR) will require each resident to demonstrate proficiency across all of diagnostic radiology by completing a Comprehensive Core Examination after 36...
Posted: June 3, 2014, 4:00 am
The FDA is reclassifying 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 renaming them sunlamp products and UV...
Posted: June 2, 2014, 4:00 am
FDA Voice Blog: OpenFDA: Innovative Initiative Opens Door to Wealth of FDA?s Publicly Available Data
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.
Posted: June 2, 2014, 4:00 am
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a ?not...
Posted: June 2, 2014, 4:00 am
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.
Posted: May 30, 2014, 4:00 am
The FDA is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special
Posted: May 30, 2014, 4:00 am
The FDA is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will..
Posted: May 30, 2014, 4:00 am
This special controls guideline was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) serological reagents. DENV serological reagents are devices that consist of antigens and antibodies for the...
Posted: May 29, 2014, 4:00 am
This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens from class III into class II. These devices are..
Posted: May 29, 2014, 4:00 am
The Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and Federal Communication Commission (FCC) announced a public workshop entitled ?Proposed Risk-Based Regulatory and Framework and...
Posted: May 29, 2014, 4:00 am
The FDA is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance...
Posted: May 29, 2014, 4:00 am
The FDA is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the pancreatic...
Posted: May 29, 2014, 4:00 am
Labeling, Approval Order, and Summary of Safety and Effectiveness for Inspire Upper Airway Stimulation (UAS) (P130008).
Posted: May 29, 2014, 4:00 am
Transcripts posted for May 6-7, 2014 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: May 28, 2014, 4:00 am
NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated for use with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate...
Posted: May 28, 2014, 4:00 am
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register...
Posted: May 28, 2014, 4:00 am
Fisher and Paykel Healthcare received 24 reports in which the device has malfunctioned. There were zero injuries and zero deaths. The firm received reports of the affected prongs detaching from the nasal tubing during use, especially when mucous and/or...
Posted: May 23, 2014, 4:00 am
The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used with Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process. ASP has notified the FDA of...
Posted: May 23, 2014, 4:00 am
Labeling, Approval Order, and Summary of Safety and Effectiveness for Gel-Syn™ (P110005).
Posted: May 23, 2014, 4:00 am
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Posted: May 23, 2014, 4:00 am
The FDA is announcing the availability of a guidance that discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's ...
Posted: May 23, 2014, 4:00 am
Transcript posted for April 24, 2014 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: May 22, 2014, 4:00 am
ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas. TPN is used to meet the nutritional needs of patients who cannot eat or drink by mouth and is...
Posted: May 22, 2014, 4:00 am
The FDA is proposing to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serologicalreagents from class I ,,,
Posted: May 22, 2014, 4:00 am
An intra-aortic balloon pump is a mechanical device that inflates a balloon placed in the patient?s thoracic aorta. The balloon inflates and deflates in order to help the heart pump blood, increase blood flow to the heart itself, and increase blood flow..
Posted: May 22, 2014, 4:00 am
GEL-SYN is an artificial material that contains sodium hyaluronate and is injected into osteoarthritic knee joint. GEL-SYN is similar to hyaluronic acid found in the knee joint space. GEL-SYN relieves pain from osteoarthritis (OA) and it functions as a...
Posted: May 21, 2014, 4:00 am
The Inspire Upper Airway Stimulation (UAS) system is an implantable nerve stimulator used to treat moderate to severe obstructive sleep apnea (OSA). The Inspire UAS system consists of implanted components including the implantable pulse generator (IPG)...
Posted: May 21, 2014, 4:00 am
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2014.
Posted: May 21, 2014, 4:00 am
CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because it may have a software failure where the pump module will not properly delay an infusion when the Delay Until option or Multidose feature is used...
Posted: May 20, 2014, 4:00 am
Meeting Notice: June 12, 2014 Circulatory System Devices Panel of the Medical Devices Advisory Committee
Posted: May 20, 2014, 4:00 am
The FDA is announcing a forthcoming meeting of a public advisory committee. The meeting will be open to the public.
Posted: May 20, 2014, 4:00 am
The FDA is announcing the workshop ``Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.' The purpose of this workshop is to provide a forum for FDA, medical device manufactures, ...
Posted: May 19, 2014, 4:00 am
The purpose of this workshop is to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3D printing. The Agency would like input regarding technical...
Posted: May 19, 2014, 4:00 am
Presentations posted for May 13, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: May 16, 2014, 4:00 am
The FDA is classifying the colon capsule imaging system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the colon capsule imaging system's...
Posted: May 16, 2014, 4:00 am
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Posted: May 16, 2014, 4:00 am
The FDA is classifying the intravascular administration set, automated air removal system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of thecodified language...
Posted: May 16, 2014, 4:00 am
The UDI rule provides a method for labelers to request exceptions, alternatives, and time extensions to UDI requirements. FDA plans to make decisions on requests for extensions, alternatives and time extensions available on this page. The UDI rule...
Posted: May 16, 2014, 4:00 am
The FDA is holding this public workshop to obtain information on the current challenges and opportunities related to hemostatic medical devices for use in emergency situations. The goals of the workshop are to discuss factors that contribute to...
Posted: May 15, 2014, 4:00 am
The FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards'). This publication will assist manufacturers...
Posted: May 15, 2014, 4:00 am
The Alere lNRatio2 PT/INR Monitoring System (Professional Use) is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin on clotting time (prothrombin time)...
Posted: May 15, 2014, 4:00 am
Meeting Notice: June 10, 2014 Oxiplex[supreg]/SP Gel; FzioMed, Incorporated's Petition for Review of the Food and Drug Administration's Denial of Premarket Approval
Posted: May 14, 2014, 4:00 am
Evaluation of Automatic Class III Designation (De Novo) Summaries (K130218 added)
Posted: May 14, 2014, 4:00 am
24 Hour Summary posted for May 13, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: May 14, 2014, 4:00 am
Evaluation of Automatic Class III Designation (De Novo) Summaries (K133448 added)
Posted: May 14, 2014, 4:00 am
The FDA is announcing a meeting to discuss CDRH's denial of a premarket approval application (PMA) for Oxiplex[supreg]/SP Gel (OXIPLEX) submitted by FzioMed, Inc.--the sponsor for OXIPLEX. The meeting will be open to the public.
Posted: May 14, 2014, 4:00 am
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: ?Hemostatic Medical Devices for Trauma Use?. The purpose of the workshop is to obtain information on the current challenges and opportunities related to Hemostatic Medical De
Posted: May 14, 2014, 4:00 am
The FDA is announcing the availability of the draft guidance ``Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.' FDA developed this draft document to provide guidance about the appropriate use of national...
Posted: May 13, 2014, 4:00 am
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Posted: May 12, 2014, 4:00 am
The FDA developed this draft document to provide guidance to industry and FDA reviewers about the appropriate use of national and international voluntary consensus standards, (referred to as consensus standards) in the preparation and evaluation of...
Posted: May 12, 2014, 4:00 am
Meeting Notice: June 6, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
Posted: May 12, 2014, 4:00 am
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available).
Posted: May 12, 2014, 4:00 am
The FDA is seeking input from interested stakeholders on how best to develop a regulatory framework targeted toward the complex issues involved in transformingresearch-level assays into validated in vitro diagnostics (IVDs) that can be used with patients.
Posted: May 12, 2014, 4:00 am
A Cardiac Resynchronization Therapy (CRT) device is a special pacemaker designed to treat symptoms of heart failure by sending specially timed electrical impulses to improve the timing, or resynchronize pumping action of the heart's lower chambers
Posted: May 9, 2014, 4:00 am
UDI Formats by FDA-Accredited Issuing Agency (May 7, 2014)
Posted: May 9, 2014, 4:00 am
GUDID Data Elements Reference Table (May 7, 2014)
Posted: May 9, 2014, 4:00 am
A Cardiac Resynchronization Therapy (CRT) device is a special pacemaker designed to treat symptoms of heart failure by sending specially timed electrical impulses to improve the timing, or resynchronize pumping action of the heart's lower chambers
Posted: May 9, 2014, 4:00 am
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: ?Proteomics in the Clinic?. The topic to be discussed is the state of the art and challenges surrounding validation of proteomic methodologies for in vitro diagnostic...
Posted: May 9, 2014, 4:00 am
The firm received customer reports of two potential malfunctions that may occur with the GemStar Docking Station. To date, there have been no reports of death or serious injury associated with these malfunctions. When the docking station is used with a...
Posted: May 9, 2014, 4:00 am
Labeling, Approval Order, and Summary of Safety and Effectiveness for Medtronic, Inc. - Expansion of the Indications for Use of CRT-D Devices (P010031S381).
Posted: May 8, 2014, 4:00 am
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Posted: May 8, 2014, 4:00 am
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.
Posted: May 8, 2014, 4:00 am
Labeling, Approval Order, and Summary of Safety and Effectiveness for Medtronic, Inc. - Expansion of the Indications for Use of CRT-P Devices (P010015S205).
Posted: May 8, 2014, 4:00 am
FDA Drug Shortages
The drug shortage program, within the Center for Drug Evaluation and Research (CDER), addresses potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health.
Resolved Drug Shortages: Ketorolac Tromethamine Injection
Posted: June 4, 2014, 7:00 pm
Resolved Drug Shortages: Mannitol (Osmitrol, Resectisol) Injection
Posted: June 4, 2014, 7:00 pm
Resolved Drug Shortages: Telavancin (Vibativ) Injection
Posted: May 30, 2014, 5:30 pm
Resolved Drug Shortages: Methazolamide (Glauctabs, Neptazane) Tablets
Posted: May 30, 2014, 5:30 pm
Resolved Drug Shortages: Echothiophate Iodide (Phospholine Iodide) Ophthalmic Kit
Posted: May 27, 2014, 6:20 pm
Resolved Drug Shortages: Intravenous Fat Emulsion Injection
Posted: May 23, 2014, 5:32 pm
Resolved Drug Shortages: Dobutamine Hydrochloride Injection
Posted: May 23, 2014, 5:32 pm
Resolved Drug Shortages: Caffeine and Ergotamine Tartrate (Cafergot) Tablet
Posted: May 22, 2014, 6:40 pm
Drugs to be Discontinued: Dicyclomine (Bentyl) Hydrochloride, USP Syrup, 10 mg/5ml
Posted: May 12, 2014, 7:05 pm
Drugs to be Discontinued: Warfarin Sodium (Coumadin) for injection, 5mg/vial
Posted: April 29, 2014, 7:40 pm
Drugs to be Discontinued: Pilocarpine hydrochloride (Pilopine HS®) ophthalmic gel 4%
Posted: April 24, 2014, 3:00 pm
New Drug Shortage: Erythrocin Lactobionate Lyophilized Powder for Injection
Posted: April 22, 2014, 7:20 pm
New Drug Shortage: Disopyramide Phosphate (Norpace) CR
Posted: April 18, 2014, 7:00 pm
Drugs to be Discontinued: Phenylephrine (MYDFRIN) Ophthalmic Solution
Posted: April 3, 2014, 5:00 pm
New Drug Shortage: Piperacillin and Tazobactam (Zosyn) Injection
Posted: April 2, 2014, 5:00 pm
New Drug Shortage: Tesamorelin (Egrifta) Injection Kit
Posted: March 27, 2014, 7:15 pm
Drugs to be Discontinued: Phenylephrine Ophthalmic Solution
Posted: March 19, 2014, 7:15 pm
Drugs to be Discontinued: Levobunolol Hydrochloride 0.25% Solution
Posted: March 17, 2014, 4:00 pm
Drugs to be Discontinued: Neostigmine bromide (Prostigmin) 15 mg Tablets
Posted: March 13, 2014, 6:00 pm
Resolved Drug Shortages: Citric Acid; Gluconolactone; Magnesium Carbonate Solution (Renacidin) Irrigation
Posted: February 19, 2014, 12:12 pm
Resolved Drug Shortages: Desmopressin Acetate (DDAVP) Injection
Posted: February 19, 2014, 12:12 pm
Resolved Drug Shortages: Sulfamethoxazole 80mg/Trimethoprim 160mg/ml Injection (SMX/TMP) (Bactrim)
Posted: February 19, 2014, 12:12 pm
Drugs to be Discontinued: Tositumomab and Iodine I 131 Tositumomab (Bexxar)
Posted: February 19, 2014, 12:12 pm
Resolved Drug Shortages: Acetylcysteine Inhalation Solution
Posted: February 19, 2014, 12:12 pm
Resolved Drug Shortages: Pegvisomant (Somavert) Injection
Posted: February 19, 2014, 12:12 pm
Resolved Drug Shortages: Buprenorphine Hydrochloride (Buprenex) Injection
Posted: February 19, 2014, 12:12 pm
Drugs to be Discontinued: Memantine Hydrochloride (Namenda) 5 mg and 10 mg Tablets
Posted: February 14, 2014, 6:40 pm
New Drug Shortage: Dexmethylphenidate Hydrochloride (Focalin) Tablet
Posted: February 13, 2014, 3:30 pm
New Drug Shortage: Methylprednisolone Sodium Succinate Injection
Posted: February 13, 2014, 3:30 pm
Resolved Drug Shortages: Aminocaproic Acid Injection
Posted: February 5, 2014, 6:13 pm
Resolved Drug Shortages: Atracurium Besylate Injection
Posted: February 5, 2014, 6:13 pm
Resolved Drug Shortages: Hydromorphone Hydrochloride (Dilaudid) Injection
Posted: February 5, 2014, 6:13 pm
Resolved Drug Shortages: Metoclopramide (Reglan) Injection
Posted: February 5, 2014, 6:13 pm
Resolved Drug Shortages: Morphine Sulfate Injection
Posted: February 5, 2014, 6:13 pm
Resolved Drug Shortages: Tromethamine (Tham) Injection
Posted: February 5, 2014, 6:13 pm
Drugs to be Discontinued: HELIDAC (bismuth subsalicylate/tetracycline hydrochloride/metronidazole) Therapy
Posted: February 3, 2014, 8:28 pm
Drugs to be Discontinued: Denileukin diftitox (Ontak) Injection
Posted: February 3, 2014, 8:28 pm
Resolved Drug Shortages: Hydromorphone Hydrochloride Tablets
Posted: February 3, 2014, 6:28 pm
Resolved Drug Shortages: Levothyroxine sodium (Levoxyl) Tablets
Posted: February 3, 2014, 6:28 pm
Resolved Drug Shortages: Isoniazid; Rifampin (Rifamate) Capsules
Posted: February 3, 2014, 6:28 pm
What's New: Drugs RSS Feed
What's New at CDER
Posted: June 6, 2014, 5:08 pm
Posted: June 6, 2014, 2:27 pm
Updated statistics and exclusivity determinations list.
Posted: June 6, 2014, 2:13 pm
Drug Establishments Current Registration Download File last updated June 06, 2014.
Posted: June 6, 2014, 1:10 pm
updated through June 06, 2014.
Posted: June 6, 2014, 1:08 pm
Drug Safety
Posted: June 5, 2014, 7:06 pm
Drug Safety
Posted: June 5, 2014, 7:04 pm
Drug Safety
Posted: June 5, 2014, 7:02 pm
Drug Safety
Posted: June 5, 2014, 7:00 pm
Drug Safety
Posted: June 5, 2014, 6:57 pm
Drug Safety
Posted: June 5, 2014, 6:56 pm
Procedural; Drug Safety
Posted: June 5, 2014, 6:54 pm
Drug Safety
Posted: June 5, 2014, 6:52 pm
Drug Safety
Posted: June 5, 2014, 6:47 pm
Drug Safety
Posted: June 5, 2014, 6:46 pm
Drug Safety
Posted: June 5, 2014, 6:44 pm
MedWatch Safety Alert RSS Feed
FDA MedWatch Safety Alerts
UPDATED 06/06/2014. Zhen Gong Fu Public Notification added. Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Posted: June 6, 2014, 2:57 pm
Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
Particulates could cause blockage of blood flow, which could be life-threatening.
Posted: June 2, 2014, 6:25 pm
Recall expanded to include all lots of the products. Originally posted 05/06/2014.
Posted: May 29, 2014, 12:42 pm
UPDATED 05/28/2014. Recall classified as Class I. Originally posted 05/22/2014.
Posted: May 28, 2014, 7:20 pm
Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.
Posted: May 23, 2014, 7:50 pm
Device malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction.
Posted: May 23, 2014, 3:05 pm
A fatal outcome is possible, especially with the high risk population.
Posted: May 22, 2014, 5:30 pm
Failure may cause pump to shut down without alarm, and result in heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.
Posted: May 22, 2014, 4:45 pm
"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.
Posted: May 21, 2014, 1:40 pm
May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.
Posted: May 16, 2014, 7:30 pm
May interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.
Posted: May 16, 2014, 6:50 pm
Risk of increased blood pressure and/or pulse rate.
Posted: May 16, 2014, 6:40 pm
Risk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy.
Posted: May 16, 2014, 4:00 am
UPDATED 05/15/2014. Recall classified as Class I.
Posted: May 15, 2014, 7:15 pm
FDA recommends a decreased starting dose for both women and men.
Posted: May 15, 2014, 6:50 pm
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response.
Posted: May 15, 2014, 6:35 pm
Study finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding.
Posted: May 13, 2014, 6:00 pm
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.
Posted: May 12, 2014, 1:45 pm
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up
UPDATED 05/09/2014. Classified as Class I Recall. A delay or interruption in therapy has a worst case potential to result in significant injury or death.
Posted: May 9, 2014, 7:45 pm