First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample Is Cleared By FDA

FOR IMMEDIATE RELEASE January 3, 2008

Media Inquiries: Peper Long, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample

The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.

The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.

"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."

Other viruses identified by the xTAG Respiratory Viral Panel:

• influenza B - one of three types of human influenza, less severe than influenza A
• respiratory syncytial virus subtype A and B – both are leading causes of infant pneumonia and bronchiolitis (an infection of the airways leading to the lungs) and often contribute to the development of long-term pulmonary disease
• parainfluenza 1, 2 and 3 – all are leading factors in the croup and the common cold
• rhinovirus – the most common viral infective agent in humans and a cause of the common cold
• adenovirus – a cause of respiratory tract infections often similar to strep throat or tonsilitis

While the test is faster than conventional tests, it is specific to the dozen viruses listed and should be used with other diagnostics such as patient data, bacterial or viral cultures and X-rays. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

The xTAG Respiratory Viral Panel is manufactured by Toronto-based Luminex Molecular Diagnostics.

tag: FDA, DRUGS, Respiratory Viruses, xTAG Respiratory Viral Panel, Influenza, metapneumovirus, syncytial virus, parainfluenza, rhinovirus, adenovirus, tonsilitis, Luminex Molecular Diagnostics

New Data on Risks of Anemia Drugs Reviewed By FDA

FOR IMMEDIATE RELEASE January 3, 2008

Media Inquiries: Karen Riley, 301-827-6244 Consumer Inquiries: 888-INFO-FDA

FDA Receives New Data on Risks of Anemia Drugs
Consistent With Previous Data on Tumor Growth and Death

The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.

These two studies were not among the six studies that were described in revised labeling approved by FDA Nov. 8, 2007, which strengthened warnings about ESAs in cancer patients.

Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater, although many patients did not reach that level.

FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications,” said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

“FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.

Physicians determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells, typically expressed in grams per deciliter.

FDA-approved uses of ESAs are for the treatment of anemia in patients with chronic kidney failure; for cancer patients whose anemia is caused by chemotherapy; and for those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.

On Nov. 30, Amgen, manufacturer of the three ESAs -- Aranesp, Epogen, and Procrit -- provided FDA with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14 percent of the patients who received Aranesp to treat their anemia had died, compared to 9.8 percent who did not receive the drug. Tumor growth was also faster in patients receiving Aranesp.

On Dec. 4, Amgen informed FDA of the results of a study by the National Cancer Institute’s Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were administered either Procrit to maintain hemoglobin levels above 12 g/dL or blood transfusions as needed. After three years, 66 percent of the patients who did not take Procrit were alive and free of cancer growth compared to 58 percent who had received the drug.

FDA approved revised boxed warnings and other safety-related product labeling changes for ESAs in November and March 2007. Safety concerns regarding ESAs were discussed during advisory committee meetings in 2004 and 2007 and labeling was revised in 1997, 2004 and 2005 to reflect new safety information

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews. FDA is committed to strengthening the science that supports medical product safety at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management.

Amgen is based in Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

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Communication about an Ongoing Safety Review

tag: FDA, DRUGS, Anemia Drugs, erythropoiesis-stimulating agents, ESAs, cervical cancer, breast cancer, tumor growth, chemotherapy, HIV, zidovudine, Aranesp, Epogen, Procrit

CPSC Recalls For 3rd January 2008

Toy Wagons Recalled by Tricam Industries Due to Violation of Lead Paint Standard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Tricam Industries Inc., of Eden Prairie, Minn., is voluntarily recalling 15,000 Metal Toy Wagons. Surface paint on the wagon bucket contains excessive levels of lead, violating the federal lead paint standard.

Bathroom Medicine Cabinets Sold at Lowe’s and The Home Depot Retail Outlets Recalled by RSI Home Products Due to Laceration Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), RSI Home Products, of Anaheim, Calif., is voluntarily recalling 8,600 Medicine Cabinets. The medicine cabinet’s mirrors can separate and break, posing a laceration hazard.

tag: CPSC, CPSC recall, Tricam Industries, Toy Wagons recall, Medicine Cabinet recall, RSI Home Products recall,

Bayer Recalls CONTOUR TS Test Strips

Test Strip Recall for CONTOUR TS

December 21, 2007

Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of our product specifications. Test results may demonstrate results 5 -17% higher.

This issue is unrelated in any way to the Contour TS meter itself and pertains only to certain test strips used with the meter. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The root cause of the problem has been identified, and corrective actions implemented including additional quality control measures to prevent recurrence. The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed – France, Austria, Turkey, Korea, Mexico, India and predominantly through mail order channels in the United States.

Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The lot numbers can be found on the bottom of the box and on the side of the bottle containing the strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected. Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned. Additional information can be found at www.bayerdiabetes.com. Please call your Bayer customer service phone number (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to get a replacement.

tag: bayer, FDA, Medical Tool Recall, Contour TS, Blood Glucose Meter, Diabetes, Contour TS strips

First Quick Test For Drug-Resistant Staph Infections Cleared By FDA

FOR IMMEDIATE RELEASE January 2, 2008

Media Inquiries: Peper Long, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Clears First Quick Test For Drug-Resistant Staph Infections
Test Identifies MRSA Bacterium in Two Hours

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain of staph bacterium that is resistant to methicillin and which has a higher rate of being fatal.

The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.

“The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment,” said Daniel G. Schultz, M.D., director, FDA’s Center for Devices and Radiological Health.

Staph infections occur most frequently among persons in hospitals and health care facilities (such as nursing homes and dialysis centers) who have weakened immune systems. Both types of bacteria also can infect healthy people.

Distinguishing between the two sources of infection is critical to successful treatment.
The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.

However, the MRSA staph bacterium is difficult to treat with ordinary antibiotics. It can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.

FDA cleared the BD GeneOhm StaphSR assay based on the results of a clinical trial at five locations. The new assay identified 100 percent of the MRSA-positive specimens and more than 98 percent of the more common, less dangerous staph specimens.

In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment. Test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.

The BD GeneOhm StaphSR test is manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J.

tag: MRSA, FDA, BD GeneOhm StaphSR, staph infection,

Weis Markets Recalls of Weis Baker’s Basket 18 Ct Fruit Miniatures and 2 lb Platters of Mini-Fruit Diamonds

Weis Markets Announces Voluntary Recall of Weis Baker’s Basket 18 Ct Fruit Miniatures and 2 lb Platters of Mini-Fruit Diamonds Due to Undeclared Allergen (Walnuts)

Contact:
Dennis V. Curtin
(570)-286-3636

Customers with concerns or questions about this recall may contact Weis Markets' customer hotline at 866-999-9347, Extension 3, which is open Monday through Friday 8 a.m. to 5 p.m.

FOR IMMEDIATE RELEASE -- December 31, 2007 -- Weis Markets today said it has initiated the voluntary recall of its Weis Baker's 18-count Fruit Miniatures and two pound platters of Mini-Fruit Diamonds in four varieties – Nut Diamond, Cheese Raspberry, Apricot and Mixed assortment. These products are being recalled because they may contain walnuts which are not identified on the label.

People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

These products, which were sold in Weis Markets' Bakeries, have been removed from store shelves and destroyed. The 18-count Fruit miniatures come in clear plastic containers and the two pound Mini Fruit Diamonds are packaged in a platter with a clear top. The UPC and code dates are listed below.

This problem came to the company's attention after a customer complaint. Concerned customers may return this product to Weis Markets for a full refund. Customers with concerns or questions about this recall may contact Weis Markets' customer hotline at 866-999-9347, Extension 3, which is open Monday through Friday 8 a.m. to 5 p.m.

Weis Baker's 18-count and two pound platters of Fruit Miniatures – Nut Diamond, Cheese Raspberry and Apricot are sold at Weis Markets including its Mr. Z's, King's and Scot's Lo-Cost units. Weis Markets operates 156 stores in five states: Pennsylvania, Maryland, New York, New Jersey and West Virginia.

The UPC Codes for the recalled product with a sell by date up to 1/5/08 are:
UPC 210100-00000 18 Ct Fruit Miniatures
UPC 210112-00000 2 lb Fruit Miniature Platters

tag: FDA, FDA Recall, Weis Baker, Weis Markets, Weis Markets Fruit Miniatures,

CPSC Recalls For 2nd January 2008

ATVs Recalled By KYMCO Due to Suspension Failure; Riders Can Lose Control of Vehicle

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), KYMCO USA, of Spartanburg, S.C., is voluntarily recalling 1,350 2006-2008 Model Year MXU 500 All Terrain Vehicles. The pivot bolts holding the rear suspension onto the frame can become loose, causing the rear swing arm to detach from the chassis posing a risk of injury or death to the operator.

tag: CPSC, CPSC recall, KYMCO USA, MXU 500 ATV