FDA Approves Drug for Chronic Drooling in Children 7/28/2010 3:58:00 PM The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

New Early Detection System Helps FDA Identify More than 100 Food Safety Problems in First 7 Months 7/28/2010 12:01:00 PM More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration’s new electronic portal in its first months of operation, the agency said today.

Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors 7/27/2010 4:57:00 PM At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

Pennsylvania Dairy Farm Agrees to Stop Improper Medication 7/27/2010 11:43:00 AM Owners agree to keep illegal drug residues out of animals sold for human consumption A Pennsylvania dairy farm has agreed to abide by federal regulations that protect meat from illegal drug residues caused by the unapproved medication of cattle before slaughter, as part of a consent decree of permanent injunction obtained by the U.S. Food and Drug Administration.

FDA Approves First Generic Enoxaparin Sodium Injection 7/23/2010 10:45:00 AM The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.

Federal Government Seizes Cyanide Antidote Kits from California Company 7/22/2010 3:00:00 PM At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays 7/22/2010 Recall due to balloon inflation assembly that may not hold air

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient 7/22/2010 Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.

Duck Hunters’ Perceptions of Risk for Avian Influenza, Georgia, USA (PDF0 7/21/2010 3:00:00 PM
To determine duck hunters’ risk for highly pathogenic avian influenza, we surveyed duck hunters in Georgia, USA, during 2007–2008, about their knowledge, attitudes, and practices.

CONSTELLATION Vision System: Recall 7/20/2010 3:15:00 PM Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient 7/20/2010 9:36:00 AM Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.

FDA and Other Federal Agencies Collaborate to Improve Chemical Screening 7/19/2010 12:07:00 PM WASHINGTON - The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods.

New Jersey Woman Sentenced for Committing Insurance Fraud and Selling Prescription Fertility Drugs via the Internet 7/19/2010 11:26:00 AM New Jersey Woman Sentenced for Committing Insurance Fraud and Selling Prescription Fertility Drugs via the Internet

Slim- 30 Herb Supplement: Undeclared Drug Ingredient 7/19/2010 8:32:00 AM Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning 7/16/2010 2:10:00 PM Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers 7/16/2010 1:30:00 PM The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

NIH Scientists Advance Universal Flu Vaccine 7/15/2010 3:00:00 PM 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.

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk 7/15/2010 2:10:00 PM A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.

U.S. songbirds carry low-risk bird flu, study finds 7/14/2010 11:04:00 AM
Reuters - Songbirds such as sparrows and thrushes carry various forms of bird flu and could potentially spread the viruses to pigs and poultry, U.S. researchers reported on Tuesday.

Coumadin 1 mg Tablet Blister Packs: Recall 7/14/2010 8:50:00 AM Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury 7/13/2010 3:00:00 PM Warning highlights the risk of severe liver injury and how this risk may be reduced.

FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall 7/13/2010 1:47:00 PM The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination.

USAID Program To Prevent Spread Of Bird Flu In Bangladesh Expands 7/12/2010 11:02:00 AM
MedicalNewsToday.com - USAID-funded initiative to prevent the spread of bird flu in Bangladesh.

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism 7/9/2010 12:35:00 PM Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

Federal Agents Seize Bee-Shield Hand Sanitizer from Puerto Rican Company 7/9/2010 11:47:00 AM At the request of the U.S. Food and Drug Administration, on Thursday, July 8, U.S. Marshals seized $230,000 worth of hand sanitizing gel made by Puerto Rico Beverage Inc. of Maunabo and distributed by Lord Pharmaceutical, LLC, doing business as Bee International Distributors. The hand sanitizer is distributed only in Puerto Rico.

FDA: New Final Rule to Ensure Egg Safety, Reduce Salmonella Illnesses Goes Into Effect 7/9/2010 10:23:00 AM The U.S. Food and Drug Administration says that as many as 79,000 illnesses and 30 deaths due to consumption of eggs contaminated with the bacterium Salmonella Enteritidis may be avoided each year with new food safety requirements for large-scale egg producers.

Que She Herbal Supplement: Undeclared Drug Ingredients 7/8/2010 3:08:00 PM Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

Chinese: FDA Public Health Alert: Que She Weight Loss Capsules Contain Potentially Harmful Ingredients 7/8/2010 2:37:00 PM ???????????????,???????????? Que She ??????????????????,???????,?????????????????????

FDA Public Health Alert: Que She Weight Loss Capsules Contain Potentially Harmful Ingredients 7/8/2010 2:05:00 PM The U.S. Food and Drug Administration today warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions 7/8/2010 1:45:00 PM New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.

FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin 7/8/2010 10:45:00 AM The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

FDA Seeks Public Comment on New Federal Menu Labeling Requirements 7/7/2010 10:07:00 AM The U.S. Food and Drug Administration today announced that it is inviting the public to submit comments and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines.

Borne on the Wing: Avian Influenza Risk in U.S. Wild Songbirds Mapped 7/6/2010 1:20:00 PM
Results are first to track avian influenza virus in passerines.

FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients 7/6/2010 11:51:00 AM The U.S. Food and Drug Administration today announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall 7/2/2010 8:15:00 PM The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure 7/2/2010 1:15:00 PM A power supply assembly failure can result in the inability to deliver defibrillation therapy.

Pharmacy Owner Sentenced to Over 4 Years for Health Care Fraud, Aggravated Identity Theft and Conspiracy to Misbrand Drugs 7/2/2010 11:14:00 AM Pharmacy Owner Sentenced to Over 4 Years for Health Care Fraud, Aggravated Identity Theft and Conspiracy to Misbrand Drugs

Theraclone Sciences Technology Uncovers Rare Anti-Influenza Antibodies 6/30/2010 3:24:00 PM
IT.tmcnet.com - Scientists have identified a new, highly conserved molecular target on the influenza A virus and demonstrated that human antibodies against this target are protective in animal models of seasonal and highly-pathogenic avian influenza.

Zoonotic Diseases: WSU Breaks Ground On School For Global Animal Health Building 6/30/2010 3:22:00 PM
MedicalNewsToday.com - Washington State University and the Gates Foundation broke ground on a 62,000-square-foot, three-story flagship research building for a new School for Global Animal Health. The first of its kind research facility will house a state-of-the-art infectious disease research center for investigating emerging disease. From Avian influenza, to West Nile virus...

NOAA, FDA, and Gulf Coast State Officials Affirm Commitment to Ensuring Safety of Gulf Coast Seafood 6/29/2010 2:59:00 PM Gulf State health and fisheries officials joined with senior leaders from several federal agencies to affirm a shared commitment to ensuring the safety of seafood coming out of the Gulf of Mexico, through closures of affected waters, surveillance, and with an eye toward reopening closed waters as soon as possible, consistent with public health goals.

FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder 6/29/2010 2:16:00 PM On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals 6/28/2010 11:44:00 AM The U.S. Food and Drug Administration today issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.

Scientists Discover New Mechanism of Bird Flu Virus Transmission 6/28/2010 9:24:00 AM
MedIndia - A new way of avian influenza circulation and transmission has been discovered by American researchers.

FDA Approves Rapid Test for Antibodies to Hepatitis C Virus 6/25/2010 11:48:00 AM The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

Anesthesiologist Sentenced on Health Care Fraud Charge 6/25/2010 11:10:00 AM Anesthesiologist Sentenced on Health Care Fraud

H1N1 Influenza Public Health Emergency Determination to Expire on June 23 6/24/2010 1:00:00 PM H1N1 Influenza Public Health Emergency Determination to Expire on June 23

Advance Notice for Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices 6/23/2010 9:00:00 AM 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.

New CDC Test to Detect Human Infections with the 2009 H1N1 Influenza Virus Authorized for Use by FDA 6/23/2010 9:00:00 AM 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.

FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market 6/21/2010 3:23:00 PM Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Mylotarg (gemtuzumab ozogamicin): Market Withdrawal 6/21/2010 3:20:00 PM Drug failed to demonstrate clinical benefit to patients enrolled in trials.

FDA to Hold Daylong Meeting on Medical Device Innovation 6/21/2010 3:07:00 PM Each day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients to realize the benefits.

FDA Marks First Anniversary of Tobacco Control Act 6/21/2010 12:13:00 PM One year ago, President Obama signed the historic Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies 6/21/2010 10:43:00 AM The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

Magic Power Coffee: Undeclared Drug Ingredient 6/21/2010 8:30:00 AM Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.

FDA Warns Consumers to Avoid Magic Power Coffee 6/19/2010 5:04:00 PM The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

WHO Updates International H1N1 Flu Situation 6/18/2010 1:30:00 PM 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.

FDA Warns About Fraudulent Tamiflu 6/17/2010 6:30:00 PM 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.

FDA Approves New Indication for Tasigna 6/17/2010 5:04:00 PM The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

Tamiflu: Counterfeit Product Sold on Internet 6/17/2010 4:00:00 PM Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.

McNeil Consumer Healthcare Over-The-Counter Products: Recall 6/17/2010 3:35:00 PM UPDATED 06/17/2010. Recall expanded to include product lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels.

FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws 6/17/2010 3:31:00 PM The FDA announced today that the American Red Cross has been fined $16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products.

FDA Warns About Fraudulent Tamiflu 6/17/2010 3:00:00 PM 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.

FDA Approves New Treatment for Advanced Prostate Cancer 6/17/2010 2:17:00 PM The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.

CDC issues 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010 6/16/2010 8:30:00 PM Centers for Disease Control and Prevention document that summarizes key events of the 2009 H1N1 pandemic and CDC's response activities.

FDA to Host Public Meeting on Oversight of Laboratory-Developed Tests 6/16/2010 9:16:00 AM The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals 6/15/2010 3:00:00 PM The U.S. Food and Drug Administration today unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

FDA Cautions on Accurate Vitamin D Supplementation for Infants 6/15/2010 12:16:00 PM The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.

Vitamin D Supplement Products: Medication Use Error 6/15/2010 12:00:00 PM Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant.

NOAA, FDA Continue Ramping Up Efforts to Ensure Safety of Gulf of Mexico Seafood 6/14/2010 5:42:00 PM The National Oceanic and Atmospheric Administration (NOAA) and the U.S. Food and Drug Administration (FDA) are taking additional steps to enhance inspection measures designed to ensure that seafood from the Gulf of Mexico reaching America’s tables is safe to eat.

National Avian Influenza Surveillance Information 6/14/2010 3:32:00 PM
85 samples and tests were added to HEDDS for 2009. Total is now 19,861.

WHO defends pandemic actions, says rules need tightening 6/14/2010 3:27:00 PM
CIDRAP News – The World Health Organization (WHO) replied at greater length today to recent criticism of the way it used science advisers in pandemic planning, defending its response to the H1N1 flu pandemic but allowing that its policies concerning transparency and relations with the pharmaceutical industry need strengthening.

Former Colorado Springs Pharmacist Sentenced for Importation and Distribution of Chinese-Made Human Growth Hormones and Conspiracy to Distribute Anabolic Steroids 6/11/2010 11:27:00 AM Former Colorado Springs Pharmacist Sentenced for Importation and Distribution of Chinese-Made Human Growth Hormones and Conspiracy to Distribute Anabolic Steroids

Benicar (olmesartan): Ongoing Safety Review 6/11/2010 11:00:00 AM FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.

FDA Seizes More Than $32,000 Worth of Bulk Honey from Philadelphia Distribution Center 6/10/2010 4:50:00 PM At the request of the Food and Drug Administration, federal marshals seized 64 drums of imported bee’s honey from a Philadelphia distribution center on June 4 because it contained a potent antibiotic that could lead to serious illness or death. The seizure occurred at the Delaware Avenue Distribution Center, 700 Pattison Avenue, in Philadelphia. The bulk honey was imported by Sweet Works Inc., of Monterey Park, California from Cheng Du Wai Yuan Bee Products Company Limited of Chengdu, China. Subsequently, it was sold to Alfred L. Wolff Inc. of Chicago, which placed it in storage.

FDA Advisory Panel to Review Dental Amalgam 6/10/2010 11:50:00 AM The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.

Hospira Brand Liposyn and Propofol: Recall 6/10/2010 9:30:00 AM Injectable products may contain particulate matter.

Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall 6/9/2010 11:25:00 AM AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.

Counterfeit Polypropylene Surgical Mesh: Initial Communication 6/8/2010 3:10:00 PM [UPDATED 06/08/2010] Recall classified as Class I. Various sizes of counterfeit flat sheets of polypropylene surgical mesh marketed in the U.S. labeled with the C. R. Bard/Davol brand name.

FDA Takes Action Against California Soy-Product Manufacturer Lifesoy 6/7/2010 10:25:00 AM Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of permanent injunction in the U.S. District Court for the Southern District of California. The consent decree requires Lifesoy to stop manufacturing and distributing food products until the company registers with the FDA and complies with federal laws regarding sanitary practices. Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The government’s complaint further alleges that Lifesoy did not hold and store the foods under proper refrigeration conditions to prevent the growth of microorganisms.

GammaGard Liquid, Immune Globulin Intravenous (Human) 6/4/2010 4:30:00 PM Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.

WHO Director-General Statement on Continuation of Pandemic Disease 6/3/2010 5:00:00 PM A global update was provided to the Committee on the pandemic situation, including a particular focus on developments in Africa and the Southern Hemisphere.

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements 6/3/2010 1:44:00 PM [UPDATED 06/03/2010] Drug labels now contain updated recommendations.

Put best interests of hens first say NFUS 6/3/2010 6:38:00 AM
SmallHolder.co.uk - NFU Scotland is calling on those members of the general public excited by the prospect of producing their own eggs and poultrymeat to make sure they put the best interests of the hens as their first priority.

Treat Your Chickens Well 6/3/2010 6:36:00 AM
Epoch Times - USDA launches biosecurity for birds campaign.

Preliminary Results: Surveillance for Guillain-Barre Syndrome After Receipt of Influenza A (H1N1) 2009 Monovalent Vaccine --- United States, 2009--2010 6/2/2010 4:30:00 PM Guillain-Barre syndrome (GBS) is an uncommon peripheral neuropathy causing paralysis and in severe cases respiratory failure and death.

FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women 6/1/2010 5:34:00 PM The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic 5/28/2010 9:56:00 AM Product contains substances which are poisonous when ingested or applied to large areas of the body.

FDA Warning: Consumers Advised Not to Use Arrow Brand Medicated Oil & -Embrocation, Aceite Medicinal La Flecha, or “????? 5/27/2010 3:00:00 PM The U.S. Food and Drug Administration today warned consumers not to purchase or use a product called “Arrow Brand Medicated Oil & Embrocation,” also labeled as “Aceite Medicinal La Flecha (Spanish) or “????? (Mandarin).” The product is potentially toxic and contains two substances, methyl salicylate and camphor, which are poisonous when ingested.

Hylenex recombinant (hyaluronidase human injection): Recall 5/26/2010 4:25:00 PM Voluntary recall of all manufactured lots has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing.

FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli 5/26/2010 12:20:00 PM The U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

Orlistat (marketed as Alli and Xenical): Labeling Change 5/26/2010 11:00:00 AM Revised labeling to include cases of severe liver injury.

FDA Announces Collaboration with Drugs.com 5/26/2010 9:37:00 AM FDA Announces Collaboration with Drugs.com

Western District of Wisconsin Announces Consent Decree Between Beehive Botanicals and the United States 5/25/2010 5:34:00 PM Stephen P. Sinnott, United States Attorney for the Western District of Wisconsin, announced that Beehive Botanicals, Inc. (“Beehive”) assented to the entry of a consent decree of condemnation and injunction, agreeing to forfeit certain bee-derived products and components to the United States. The products and components were seized from Beehive’s facility in Hayward, Wis.

FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors 5/25/2010 3:53:00 PM The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

Proton Pump Inhibitors (PPI): Class Labeling Change 5/25/2010 3:00:00 PM Possible increased risk of fractures of the hip, wrist, and spine.

FDA Approves New Treatment for Late-Onset Pompe Disease 5/25/2010 11:25:00 AM The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change 5/25/2010 10:28:00 AM Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.

FDA and NIH Launch Electronic Safety Reporting Portal 5/24/2010 2:58:00 PM The Food and Drug Administration and the National Institutes of Health today launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats.

Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits 5/24/2010 2:24:00 PM Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced today.

FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization 5/24/2010 12:00:00 PM The U.S. Food and Drug Administration today announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.