Hot Topics

ADHD Medications Do Not Cause Genetic Damage in Children 11/19/2008 10:00:00 AM In contrast to recent findings, two of the most common medications used to treat attention deficit hyperactivity disorder (ADHD) do not appear to cause genetic damage in children who take them as prescribed, according to a new study by researchers at the National Institutes of Health (NIH) and Duke University Medical Center.

Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel 11/17/2008 3:30:00 PM Voluntary recall due to samples of the products containing Burkholderia Cepacia bacteria.

US Provides Record Level of Support Against AI 11/17/2008 10:49:00 AM
ThePoultrySite.com reports the US will provide more than $44 million in additional funding to the United Nations' flu campaign.

FDA Warns Public of Extortion Scam by FDA Impersonators 11/14/2008 10:08:00 PM The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Shop CPSC Toy Safety Tips Before Shopping for Holiday Gifts 11/14/2008 10:08:00 PM The holidays are here and the U.S. Consumer Product Safety Commission (CPSC) has its list. Parents and gift buyers are encouraged to check it twice.

Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments 11/14/2008 10:07:00 PM Johnson & Johnson - Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICONŽ GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide.

Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa) 11/12/2008 3:30:00 PM Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) 11/12/2008 3:30:00 PM Product recalled because some bottles of the product could include metal fragments..

Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg) 11/10/2008 11:40:00 AM Generic products recalled because of the potential for oversized tablets that could cause serious or life-threatening consequences.

Sherwin-Williams Co. Recalls Krylon UV Fabric Protector Due to Respiratory Hazard 11/7/2008 10:47:00 PM Overexposure to fumes, vapor or spray mist from the product can pose a serious respiratory hazard to consumers. The recall involves Krylon "Outdoor Spaces" UV Fabric Protector, which is an aerosol coating used to protect fabric.

Genetics Provide Evidence for the Movement of Avian Influenza Viruses from Asia to North America via Migratory Birds 11/7/2008 12:45:00 PM Wild migratory birds may be more important carriers of avian influenza viruses from continent to continent than previously thought, according to new scientific research that has important implications for highly pathogenic avian influenza virus surveillance in North America. As part of a multi-pronged research effort to understand the role of migratory birds in the transfer of avian influenza viruses between Asia and North America, scientists with the U.S. Geological Survey (USGS), in collaboration with the U.S. Fish and Wildlife Service in Alaska and the University of Tokyo, have found genetic evidence for the movement of Asian forms of avian influenza to Alaska by northern pintail ducks.

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien) 11/6/2008 10:15:00 AM Recall due to mislabeling that could lead to incorrect insulin dosing.

Wild Birds Carry Avian Flu Viruses to U.S.: Report 11/4/2008 1:38:00 PM
Reuters reports U.S. government researchers reported migrating waterfowl may be carrying avian influenza viruses from Asia to the Americas.

September 2008 Safety-Related Labeling Changes 11/4/2008 10:50:00 AM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.

Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator 10/31/2008 5:30:00 PM Class I recall because of unsupported claims.

November 2008 Patient Safety News 10/31/2008 3:00:00 PM Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Halloween Shoppers Beware -- Even Cosmetic Contact Lenses Require Prescriptions 10/30/2008 9:05:00 PM The Halloween season spells big business for the cosmetic contact lens industry, as consumers shop for just the right lenses to play the part of a mummy or vampire, or to change the color of their eyes for the evening.

American Red Cross Offers 'Trick' to Safety this Halloween 10/30/2008 9:04:00 PM Ghouls and goblins will take over the night. But even scary creatures need to be safe and celebrate Halloween right. Halloween's greatest hazards aren't vampires and villains, but falls, costume mishaps and automobile collisions.

Thoratec HeartMate II Left Ventricular Assist System 10/28/2008 3:15:00 PM Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death.

Genetics Provide Evidence for the Movement of Avian Influenza Viruses from Asia to North America via Migratory Birds 10/27/2008 12:45:00 PM Wild migratory birds may be more important carriers of avian influenza viruses from continent to continent than previously thought, according to new scientific research that has important implications for highly pathogenic avian influenza virus surveillance in North America. As part of a multi-pronged research effort to understand the role of migratory birds in the transfer of avian influenza viruses between Asia and North America, scientists with the U.S. Geological Survey (USGS), in collaboration with the U.S. Fish and Wildlife Service in Alaska and the University of Tokyo, have found genetic evidence for the movement of Asian forms of avian influenza to Alaska by northern pintail ducks.

US Pledges Additional $320 Million in Fight Against Bird Flu 10/27/2008 12:45:00 PM Sharm el-Sheikh, Egypt: With the announcement of a new pledge of $320 million for avian and pandemic influenza assistance, U.S. support to international organizations and to more than 90 countries now totals $949 million. Under Secretary of State for Democracy and Global Affairs, Paula Dobriansky, announced the U.S. pledge today at the International Ministerial Conference on Avian and Pandemic Influenza at Sharm el-Sheikh, Egypt.

Healing Process Found to Backfire in Lung Patients 10/27/2008 11:00:00 AM A mechanism in the body which typically helps a person heal from an injury, may actually be causing patients with idiopathic pulmonary fibrosis (IPF) to get worse, researchers at the National Institute of Environmental Health Sciences (NIEHS), a part of the National Institutes of Health (NIH), and their collaborators have found.

Infant Death Prompts Recall to Repair 985,000 Delta Enterprise Drop Side Cribs; Missing Safety Pegs Can Cause Entrapment and Suffocation Hazards 10/24/2008 4:21:00 PM The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Delta Enterprise Corp., of New York, New York., is announcing the voluntary recall to replace missing safety pegs involving 985,000 drop side cribs. Failure to use or install safety pegs can cause an entrapment and suffocation risk to infants and toddlers.

Kids and Pets: CDC Advice for Staying Healthy and Happy 10/24/2008 4:20:00 PM CDC experts caution parents, pediatricians, and veterinarians to be aware of the risks that exotic animals and pets can pose to children. A study released in Pediatrics' October issue outlined the diseases that can be transmitted to children when they come in contact with reptiles, rodents, mammals, birds, amphibians, non-human primates and fish.

Transvaginal Placement of Surgical Mesh 10/21/2008 3:40:00 PM Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

Early Pandemic Flu Wave May Protect Against Worse One Later 10/20/2008 1:40:00 PM New evidence about the worldwide influenza pandemic of 1918-1919 indicates that getting the flu early protected many people against a second deadlier wave, an article co-authored by an NIH epidemiologist concludes.

Raptiva (efalizumab) 10/17/2008 4:46:00 PM Risk of life-threatening infections associated with Raptiva use.

HHS Announces Physical Activity Guidelines for Americans 10/16/2008 6:21:00 PM Adults gain substantial health benefits from two and a half hours a week of moderate aerobic physical activity, and children benefit from an hour or more of physical activity a day, according to the new Physical Activity Guidelines for Americans.

Dextroamphetamine Sulfate 5mg Tablets 10/16/2008 11:23:00 AM Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects.

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100% Whole Wheat 10/10/2008 7:59:00 PM Arnold Foods Company, Inc. is recalling BROWNBERRY brand Whole Grains BREAD 100% WHOLE WHEAT (1 LB 8 OZ) because it may contain undeclared almonds, walnuts and hazelnuts.

FDA Statement Following CHPA's Announcement on Nonprescription Over- the-Counter Cough and Cold Medicines in Children 10/10/2008 7:58:00 PM The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children.

FDA Clears New CDC Test to Detect Human Influenza 10/10/2008 2:50:00 PM
The U.S. Food and Drug Administration (FDA) today cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.

Over The Counter Cough and Cold Medications 10/9/2008 4:40:00 PM Product labels being modified to state "do not use" in children under 4 years of age.

CDC Awards $16.9 Million to Combat Pandemic, Seasonal Influenza 10/9/2008 1:40:00 PM The Centers for Disease Control and Prevention (CDC) has awarded a $16.9 million contract to American Type Culture Collection (ATCC) of Manassas, Va. to implement the CDC Influenza Reagent Resource (CDC-IRR), a secure, Web-based system that will improve access to influenza viruses, test kits and other reagents for approved laboratories.

Climate Change Seen Aiding Spread of Deadly Diseases 10/8/2008 9:31:00 AM
Reuters reports - diseases ranging from avian flu to yellow fever are likely to spread more because of climate change, according to the Wildlife Conservation Society .

How To Reduce Sewage Flooding In Your Home 10/7/2008 4:08:00 PM After all the flooding of the last few months, some residents experienced sewer backup. Disaster officials overseeing state-federal recovery efforts suggest homeowners in flood-prone areas consider taking practical steps to lessen this type of damage in the future.

Tiotropium (marketed as Spiriva HandiHaler) 10/7/2008 11:32:00 AM UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics.

Nebion HLX-8 Magnetic Resonance Device 10/3/2008 4:10:00 PM Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food 10/3/2008 1:10:00 PM The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.

Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit 10/2/2008 10:50:00 AM Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump.

October 2008 Patient Safety News 10/1/2008 5:55:00 PM Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

FDA Awards $5.2 Million in Grants to Further Food and Feed Safety 9/30/2008 10:11:00 PM The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.

FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years 9/30/2008 10:11:00 PM The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.

Statin drugs and amyotrophic lateral sclerosis (ALS) 9/30/2008 11:00:00 AM New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS.

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease 9/29/2008 8:16:00 PM A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease.

Listeria 9/26/2008 7:28:00 PM Its not something you hear about often, but listeria can be dangerous. ...

Publication of the Week: Handout on Health: Sports Injuries 9/26/2008 7:27:00 PM Learn what kinds of exercise activities are most likely to cause injuries, how to prevent them, and treatments available.

FDA Updates Health Information Advisory on Melamine Contamination 9/26/2008 3:28:00 PM The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

Epoetin alfa 9/26/2008 11:10:00 AM Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo.

Scientists Working To Protect Northern Ireland From Bird Flu 9/24/2008 11:07:00 AM
MedicalNewsToday.com reports Queen's University Belfast scientists are involved in projects aimed to protect Northern Ireland's agri-food industry from Bird Flu and African Swine Fever.

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain 9/23/2008 3:30:00 PM The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% 9/23/2008 2:35:00 PM Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process.

Tarceva (erlotinib) 9/23/2008 2:35:00 PM Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.

Infant Formula Manufactured in China Contaminated With Melamine 9/22/2008 11:25:00 AM UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves.

FDA Updates Health Information Advisory on Melamine Contamination 9/20/2008 2:09:00 PM On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.

FDA Drug Safety Newsletter 9/18/2008 3:22:00 PM Summer 2008 edition available for healthcare professionals and the medical community.

FDA Proposes Label Requirements for Refused Imported Foods 9/18/2008 3:17:00 PM The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals 9/18/2008 2:00:00 PM The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

Phosphocol P 32 (Chromic Phosphate P 32 Suspension) 9/18/2008 2:00:00 PM Risk of leukemia associated with off-label intra-articular use in children.

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India 9/16/2008 6:30:00 PM The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

August 2008 Safety-Related Labeling Changes 9/16/2008 11:45:00 AM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.

LifePak CR Plus Automated External Defibrillators 9/16/2008 11:45:00 AM UPDATE - Recall classified as Class I.

NIEHS Invests $21.25 Million to Find Environmental Causes of Parkinsons Disease 9/16/2008 9:00:00 AM The National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health (NIH), announced today that it will award three new grants totaling $21.25 million over a five-year period to study how environmental factors contribute to the cause, prevention and treatment of Parkinsons disease and other related disorders.

New AI Vaccine Developed 9/15/2008 2:07:00 PM
World Poultry reports a new vaccine, Vaxin, has been shown to provide excellent protection when administered to poultry before hatching.

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers 9/12/2008 9:39:00 PM The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

CPSC Focuses On Safety in the Nursery and Around the House for Baby Safety Month 9/12/2008 9:37:00 PM As parents prepare for a new baby with love and care, CPSC urges keeping safety in the mix. One area of great concern for the CPSC is pillow use in cribs. ...

FDA Approves Treatment for Rare Neurologic Disease 9/12/2008 8:50:00 PM The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

Infant Formula Manufactured in China 9/12/2008 3:12:00 PM FDA issues Health Information Advisory due to reports of contamination with melamine.

FDA Issues Health Information Advisory on Infant Formula 9/12/2008 2:26:00 PM In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.

FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case 9/11/2008 6:39:00 PM The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food.

LifePak CR Plus Automated External Defibrillators 9/11/2008 2:55:00 PM Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy.

Rituxan (rituximab) 9/11/2008 1:15:00 PM Progressive Multifocal Leukoencephalopathy with use of Rituxan in patient with rheumatoid arthritis.

SLU Looks for Volunteers for Avian Flu Study 9/9/2008 2:48:00 PM
St. Louis Business Journal reports Saint Louis University School of Medicine is about to undertake one of the largest avian flu clinical trials in the nation.

Disposable Battery Operated Lavage System (BOLS) 9/8/2008 2:46:00 PM The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions.

FDA to Post Quarterly Report of Potential Safety Issues 9/5/2008 3:57:00 PM The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

CDC Launches CDC-TV On-Line Video Resource 9/4/2008 9:15:00 PM The Centers for Disease Control and Prevention has launched CDC-TV, a new online video resource available through www.cdc.gov. CDC-TV videos will cover a variety of health, safety and preparedness topics. ...

Tornadoes, Hurricanes and Children 9/4/2008 9:09:00 PM The intense anxiety and fear that often follow a disaster can be especially troubling for surviving children, especially if children were victims of the disaster or were separated from their families. ...

Managing Traumatic Stress: After the Hurricanes 9/4/2008 9:09:00 PM The effects of the recent hurricanes will be long-lasting and the resulting trauma can reverberate even with those not directly affected by the disaster. ...

FDA Approves DNA Test to Measure Hepatitis B Virus Levels 9/4/2008 6:12:00 PM The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

Tumor necrosis factor-a blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) 9/4/2008 4:37:00 PM Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-a blockers.

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections 9/4/2008 3:14:00 PM The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures 9/4/2008 1:26:00 PM The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

University of Delaware Poultry Researchers Win $5M USDA Grant 9/3/2008 1:09:00 PM
CapeGazette.com reports researchers at the University of Delaware will receive a $5 million dollar grant from the U.S. Department of Agricultures Cooperative State Research, Education and Extension Service. The grant renews the Avian Influenza Coordinated Agricultural Project.

September 2008 Patient Safety News 8/30/2008 11:45:00 AM Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Medicare Enhances Consumer Information on Hospital Care 8/29/2008 5:25:00 PM The Centers for Medicare & Medicaid Services (CMS) announced important additions to the Hospital Compare consumer Web site that will give consumers even better insight into the quality of care provided by their local hospitals. ...

CPSC Offers Tips for Back to School Safety 8/29/2008 5:21:00 PM More than 50 million children are headed back to school this fall and the U.S. Consumer Product Safety Commission (CPSC) is urging parents to pay special attention to safety this school year. ...

Preparing for a Weather Emergency 8/29/2008 5:20:00 PM Severe weather events can mean power outages, floods, and other problems that can affect the safety of food. Knowing what to do before and after a weather event can help you reduce your risk of illness. ...

Pacific Consolidated brand Mobile Oxygen Storage Tank 8/28/2008 2:40:00 PM Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.

Tysabri (natalizumab) 8/25/2008 3:22:00 PM Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year.

Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) 8/21/2008 7:55:00 PM Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.

Byetta (exenatide) 8/21/2008 10:56:00 AM UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta.

Overcoming Infertility 8/19/2008 6:21:00 PM It may feel like youve been trying to get pregnant without success forever. ...

Makers of Airborne Settle FTC Charges of Deceptive Advertising: Consumers Have Until September 15 to Apply for Refunds 8/19/2008 6:16:00 PM According to the FTCs complaint, there is no competent and reliable scientific evidence to support the claims made by the defendants that Airborne tablets can prevent or reduce . . .

July 2008 Monthly Safety Labeling 8/14/2008 12:45:00 PM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System 8/14/2008 11:45:00 AM Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.

H9N2 Avian Flu Strain Has Pandemic Potential 8/13/2008 8:38:00 AM
ScienceNews.org reports a type of avian flu virus known as H9N2 could become transmissible in humans with just a few changes, a new study shows.

Vivitrol (naltrexone) 8/12/2008 2:55:00 PM Serious injection site reactions may occur with the use of injectable naltrexone.

Fentanyl Transdermal System CII Patches 8/12/2008 2:55:00 PM UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.

Vivitrol (naltrexone) 8/12/2008 2:55:00 PM Serious injection site reactions may occur with the use of injectable naltrexone.

Fentanyl Transdermal System CII Patches 8/12/2008 2:55:00 PM UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.

Knowledge, Attitudes, and Practices Regarding Avian Influenza (H5N1), Afghanistan 8/11/2008 10:54:00 AM
Leslie T, Billaud J, Mofleh J, Mustafa L, Yingst S.
Knowledge, attitudes, and practices regarding avian influenza (H5N1), Afghanistan. Emerg. Infect. Dis. 2008 Sep; [Epub ahead of print]

New Bird Flu Strain Detected in Nigeria 8/11/2008 9:38:00 AM
StackYard.com reports a strain of Highly Pathogenic Avian Influenza previously not recorded in sub-Saharan Africa has been detected in Nigeria for the first time.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) 8/8/2008 10:30:00 AM UPDATE - Dear Healthcare Professional letter added.

Simvastatin Used With Amiodarone 8/8/2008 10:30:00 AM Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily.

Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) 8/7/2008 12:40:00 PM UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert.

Crawling the Web: H5N1 and 1918 Flu Virus 8/5/2008 12:47:00 PM
ScientistLive.com looks at the H5N1 and 1918 pandemic influenza virus, candida infection, and genome selection.

August 2008 Patient Safety News 8/1/2008 6:08:00 PM Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) 8/1/2008 6:08:00 PM Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death.

Viapro 375mg Capsules 7/31/2008 3:00:00 PM Product recalled because it was found to contain a potentially harmful analog of Sildenafil.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) 7/31/2008 3:00:00 PM FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products.

Protect Your Skin During the Summer Months 7/31/2008 2:59:00 PM When youre outside, take simple precautions to keep your skin safe and healthy. To protect your skin, apply sunscreen, use bug repellent, and keep skin clean. ...

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder 7/31/2008 2:58:00 PM The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). ...

Alcohol Binges Early in Pregnancy Increase Risk of Infant Oral Clefts 7/31/2008 12:00:00 PM A new study by researchers at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, shows that pregnant women who binge drink early in their pregnancy increase the likelihood that their babies will be born with oral clefts.

Rize 2 The Occasion Capsules, Rose 4 Her Capsules 7/30/2008 8:10:00 PM UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil.

Highly Pathogenic Avian Influenza Virus (H5N1) Isolated from Whooper Swans, Japan 7/30/2008 12:57:00 PM
EID reports four whooper swans were found dead at Lake Towada, Akita prefecture, Japan. Highly pathogenic avian influenza virus of the H5N1 subtype was isolated from specimens of the affected birds. The hemagglutinin (HA) gene of the isolate belongs to clade 2.3.2 in the HA phylogenetic tree.
Yuko Uchida, Masaji Mase, Kumiko Yoneda, Atsumu Kimura, Tsuyoshi Obara, Seikou Kumagai,
Takehiko Saito, Yu Yamamoto, Kikuyasu Nakamura, Kenji Tsukamoto, and Shigeo Yamaguchi

Two Dead Birds Found At Olympic Equestrian Site in Hong Kong; Authorities Testing For Bird Flu 7/30/2008 12:37:00 PM
The International Herald Tribune reports two birds were discovered dead at the Olympic equestrian venue in Hong Kong, and authorities were testing whether the birds have the H5N1 virus.

Nigeria Reports Fresh Bird Flu Outbreak 7/30/2008 12:28:00 PM
AFP reports Nigerian authorities have reported a new outbreak of bird flu virus.

South Korean Cat Had The H5N1 Bird Flu 7/30/2008 12:25:00 PM
UKmedix.com reports Korea has confirmed that a cat which was found dead died from the effects of the deadly H5N1 bird flu virus.

June 2008 Monthly Safety Labeling 7/29/2008 3:26:00 PM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Mitoxantrone Hydrochloride (marketed as Novantrone and generics) 7/29/2008 3:00:00 PM Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS.

Abacavir (marketed as Ziagen) and Abacavir-containing Medications 7/24/2008 1:47:00 PM Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment.

Dead Cat to Be Examined for Bird Flu 7/24/2008 1:22:00 PM
KoreaTimes.co.kr reports authorities in Korea are examining a cat to determine whether it was infected with the highly pathogenic strain of avian influenza.

Grande Produce, LTD.CO Recalls Jalapeńo Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk 7/23/2008 3:48:00 PM Grande Produce, LTD. CO of Hidalgo, Texas (hereinafter referred to as Grande Produce) is recalling Jalepeno Peppers and Serrano Peppers distributed between May 17th and July 17th, 2008; and Avocados, all sizes, with lot #HUE08160090889 because they have the potential to be contaminated with Salmonella. ...

Bird Flu Mutates During Race Against Time To Find Vaccine 7/21/2008 9:00:00 AM
The Examiner reports according to a report on the H5N1 virus experts think could out-kill the infamous 1918 pandemic flu.

Britain Faces 75,000 Deaths in Bird Flu Pandemic, Lords Report Predicts 7/21/2008 8:56:00 AM
Guardian.co.uk reports in the United Kingdom a parliamentary committee warns in a new report of up to 75,000 Britons will in die in an "inevitable" flu pandemic that could kill as many as 50 million people worldwide.

Evaluating Private Residential Treatment Programs for Troubled Teens: FTC Urges Caution When Considering 'Boot Camps' 7/17/2008 9:22:00 PM When parents or guardians are considering finding a residential treatment program for a troubled teenager, the decision is often a difficult one. ...

lmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk 7/17/2008 9:22:00 PM Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes. ...

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) 7/17/2008 3:45:00 PM Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.

Vaccinated Chickens in Vietnam Die of Bird Flu 7/17/2008 9:48:00 AM
EarthTimes.org reports hundreds of chickens in Vietnam died of avian influenza even though the owner reported the birds were vaccinated.

Possible Future Avian Influenza Pandemic May Be Eased By Booster Vaccination 7/17/2008 9:43:00 AM
MedicalNewsToday.com reports a study published in the August 1 issue of The Journal of Infectious Diseases, on vaccination against H5N1 avian influenza, now available online.

Publication of the Week: Indoor Air Hazards Every Homeowner Should Know About 7/14/2008 5:30:00 PM This booklet can help you identify things in your home that may impact the quality of your indoor air and your health. ...

Avastin (bevacizumab) 7/14/2008 2:30:00 PM Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination.

Publication of the Week: Indoor Air Hazards Every Homeowner Should Know About 7/10/2008 6:54:00 PM This booklet can help you identify things in your home that may impact the quality of your indoor air and your health. ...

May 2008 Monthly Safety Labeling 7/10/2008 3:09:00 PM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Herceptin 440 mg Vials and BWFI Diluent 7/10/2008 1:14:00 PM Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients.

Fluoroquinolone Antimicrobial Drugs 7/8/2008 11:41:00 AM BOXED WARNING and Medication Guide to be added to prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

Summer Fire Safety Tips From FEMA 7/3/2008 7:39:00 PM Every year, Americans look forward to summer vacations, camping, family reunions, and picnics. ...

Rize 2 The Occasion Capsules and Rose 4 Her Capsules 7/2/2008 4:13:00 PM Certain lots of both products were recalled because they contained an undeclared ingredient.

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion 7/2/2008 1:08:00 PM Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.

Myfortic (mycophenolate acid) 7/1/2008 4:09:00 PM Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

July 2008 Patient Safety News 7/1/2008 2:24:00 PM Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

April 2008 Monthly Safety Labeling 7/1/2008 11:33:00 AM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

March 2008 Monthly Safety Labeling 7/1/2008 11:33:00 AM Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Pacific Rim Prepares for New Avian Flu 7/1/2008 7:52:00 AM
UPI reports the governments of Japan, China and South Korea are making joint preparations in the event of an outbreak of a new strain of avian flu.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product 6/30/2008 5:22:00 PM Product recalled due to the presence of Burkholderia cepacia.

Seeking Exceptional Candidates for Director of NIEHS 6/25/2008 12:00:00 PM FThis website is designed to host advertisements of senior-level, executive type positions such as the Senior Executive Service, IC Directors, Deputy Directors, and other positions with similar characteristics.

Scientists Create Avian Flu Vaccine with Monkey Cells 6/25/2008 8:15:00 AM
WorldPoultry.net reports using the cells of monkeys can make a vaccine against avian flu.

New Bird Flu Outbreak in Pakistan 6/25/2008 8:08:00 AM
Indo-Asian News Service reports Pakistan has confirmed a new outbreak of avian flu in a poultry farm.

Unsold Live Chickens To Be Culled Daily In HK To Avoid Bird Flu 6/25/2008 8:04:00 AM
Xinhua news reports the Hong Kong government announced that unsold live chickens will banned from overnight stays at retail markets when chicken sales resume on July 2.