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During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
Highlights of legislative meetings from February 2, 2012.
Highlights of legislative meetings from February 1, 2012.
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Highlights of legislative meetings from January 31, 2012.
Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
Highlights of legislative meetings from January 26, 2012.
Highlights of legislative meetings from January 25, 2012.
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
Possibility of an adverse reaction or unknown drug-drug interaction.
New Boxed Warning and Contraindication highlighting these risks added to product labeling.
UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82.
Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient.
Particulate matter in injections can be harmful when introduced into the bloodstream.
A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.
Consumers are asked to either destroy or return unused product identified in the recall to Novartis.
Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
Ventilator may stop ventilating and result in life-threatening injury or death.
Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.
Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.
After a week of negotiations continued through Friday night and into Saturday morning, an open-ended working-group meeting of Member States successfully agreed upon a framework to ensure that in a pandemic, influenza virus samples will be shared with partners who need the information to take steps to protect public health.
A contract has been awarded to develop a long-acting single-dose antiviral drug for use in the United States, the U.S. Biomedical Advanced Research and Development Authority (BARDA) announced today.
The U.S. Department of Health and Human Services today unveiled an innovative new website to help parents and other consumers learn about the most effective way to protect themselves and their children from infectious diseases and learn about immunization.
Guidance for the Prevention and Control of Influenza in the Peri- and Postpartum Settings
The 2009 H1N1 influenza A virus continues to circulate among the human population as the predominant H1N1 subtype.
The World Health Organization (WHO) Recommends Vaccine Composition for the 2011-2012 Northern Hemisphere Influenza Season
Flu surveillance, laboratory testing and inventory tools for use by Centers for Disease Control and Prevention (CDC) international partners and collaborating countries.
U.S. Department of Health and Human Services Secretary Kathleen Sebelius today announced that Walgreens has agreed to donate $10 million in vouchers for free flu shots to 350,000 eligible uninsured and underserved people in 15 markets across the country.
2009 Results of NIH-supported study now available
Last year, as the world prepared for a pandemic of the 2009 H1N1 influenza virus, we were reminded of the severity and unpredictability of this serious disease.
The costly, time-consuming process of making, distributing and administering millions of seasonal flu vaccines would become obsolete if researchers could design a vaccine that confers decades-long protection from any flu virus strain.
The Centers for Disease Control and Prevention (CDC) has set aside the week of December 5-11, 2010 to observe this season's National Influenza Vaccination Week. The week-long emphasis on flu vaccination was established to highlight the importance of continuing influenza vaccination...
Because pregnant women are at increased risk for severe disease associated with influenza infection, the American College of Obstetricians and Gynecologists and the Advisory Committee on Immunization Practices have recommended seasonal influenza vaccination for women while pregnant, regardless of trimester...
Efforts to grow the vaccine virus in cells rather than eggs are currently under way and there is consideration of the addition to influenza vaccine of immune-stimulating adjuvants to be used in certain groups of individuals.
The following guidance on the use of influenza antiviral drugs for the prevention and control of influenza during the 2010-2011 season has been submitted to the Morbidity and Mortality Weekly Report (MMWR) and will appear in that publication at a later date.
A new commentary by researchers at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, explores the 1510 pandemic and what we have learned since then about preventing, controlling and treating influenza.
Secondary infections with bacteria such as Streptococcus pneumoniae, which causes pneumonia, were a major cause of death during the 1918 flu pandemic and may be important in modern pandemics as well.
Questions and answers on the safety of the 2010-2011 flu vaccine, including possible mild reactions.
Toolkit and other materials for businesses, employers, and their employees to learn ways to prevent the flu.
Because the novel influenza A (H1N1) virus [2009 influenza A (H1N1)] was identified in April 2009, two separate influenza vaccines were distributed in the United States in 2009–2010: a seasonal vaccine and an influenza A (H1N1) 2009 monovalent vaccine (2009 H1N1 vaccine).
Answers to common questions regarding influenza vaccine strain selection, including information on the virus strains recommended for use in the Northern and Southern Hemisphere influenza vaccines.
Answers to common questions regarding influenza vaccine strain selection, including information on the virus strains recommended for use in the Northern and Southern Hemisphere influenza vaccines.
Answers to common questions regarding influenza vaccine strain selection, including information on the virus strains recommended for use in the Northern and Southern Hemisphere influenza vaccines.
The contract will help fill the need for domestically manufactured, low-cost, user-friendly, and flexible next-generation ventilators.
Saudi Arabia updates its health and immunization requirements for travelers
As the United States prepares for the upcoming flu season, a group of researchers supported by the National Institutes of Health continues to model how H1N1 may spread.
Cleaning and disinfecting are part of a broad approach to preventing infectious diseases in schools. To help slow the spread of influenza (flu), the first line of defense is getting vaccinated. Other measures include covering coughs and sneezes, washing hands, and keeping sick people away from others. Below are tips on how to slow the spread of flu specifically through cleaning and disinfecting.
This document from the Centers for Disease Control and Prevention (CDC), an agency of the U.S. Department of Health and Human Services, provides guidance to help reduce the spread of seasonal influenza (flu) among students and staff in K-12 schools during the 2010-2011 school year.
La limpieza y la desinfección son parte de una amplia estrategia para prevenir las enfermedades infecciosas en las escuelas. Para ayudar a disminuir la propagación de la influenza (gripe), la primera l�ínea de defensa es la vacunación. Otras medidas comprenden cubrirse la nariz y la boca al toser o estornudar, lavarse las manos y mantener a las personas enfermas alejadas de las sanas.
This document provides lists of facts and recommendations for health care workers concerning the flu and vaccinations.
Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu
HHS Secretary releases review and recommendations driven by pandemic flu experience
The world is now in the post-pandemic period. Based on knowledge about past pandemics, the H1N1 (2009) virus is expected to continue to circulate as a seasonal virus for some years to come.
The world is no longer in phase 6 of influenza pandemic alert. We are now moving into the post-pandemic period. The new H1N1 virus has largely run its course.
Recommended Flu Vaccines for Different Age Groups - U.S., 2010-11 Season
CSL Seasonal Influenza Vaccine Safety in the
United States
As of 1 August 2010, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18449 deaths.
The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.
For many years, researchers have been working to find a way to deliver flu vaccine - whose components are much larger than those of nicotine and hormones - using a transdermal (across the skin) patch.
This report updates the 2009 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccine for the prevention and control of influenza.
A universal influenza vaccine - so-called because it could potentially provide protection from all flu strains for decades - may become a reality because of research led by scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
H1N1 Influenza Public Health Emergency Determination to Expire on June 23
A test developed by the U.S. Centers for Disease Control and Prevention to diagnose human infections with the 2009 H1N1 influenza virus (formerly known as swine flu or pandemic H1N1 flu) was authorized for use today by the U.S. Food and Drug Administration.
Per the FDA-issued advance notice letters listed below, the declaration of Public Health Emergency determination for 2009 H1N1 Influenza expires on June 23, 2010.
As of 13 June, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18172 deaths.
The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as Generic Tamiflu sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.
Centers for Disease Control and Prevention document that summarizes key events of the 2009 H1N1 pandemic and CDC's response activities.
Mice injected with a 2009 H1N1 pandemic influenza vaccine and then exposed to high levels of the virus responsible for the 1918 influenza pandemic do not get sick or die, report scientists funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
A global update was provided to the Committee on the pandemic situation, including a particular focus on developments in Africa and the Southern Hemisphere.
Guillain-Barre syndrome (GBS) is an uncommon peripheral neuropathy causing paralysis and in severe cases respiratory failure and death.
