FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair

The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The possible association has been identified based on interim results from an ongoing study of Xolair known as Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

An FDA Early Communication is available online.

The Early Communication is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Once its review is completed, the FDA will communicate its findings and any resulting recommendations to the public. Until the evaluation is completed, health care professionals and patients should be aware that the agency is reviewing data that may suggest a risk of adverse events. The FDA is not advising a change in prescribing or use of the drug.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test

Biosite Incorporated has initiated a voluntary, nationwide recall of one lot of Triage® Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction (heart attack). The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin. A root cause investigation has been initiated.

The recall is limited to the Triage® Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

Biosite Incorporated has reported the action to the U.S. Food and Drug Administration.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow on Twitter @GAFrontPage

Stents Can Treat - Not Just Prevent - Strokes, Suggests Early Research

/PRNewswire/ -- Stents can be placed in the brain to treat a stroke as it's occurring, suggests preliminary data being presented at the 21st Annual International Symposium on Endovascular Therapy (ISET).

Stents have long been used to open up blocked blood vessels in the heart to prevent heart attacks and in the neck to prevent strokes. More recently stents have been used in the heart to treat occurring heart attacks by opening up the blocked arteries. This early research suggests stents also can be used to treat occurring strokes, by opening up blocked arteries in the brain.

Treatments for ischemic stroke currently include delivering clot-busting drugs to the blockage through the veins or directly into the clot through an artery, or by removing the clot with a tiny corkscrew-like device or vacuuming it out. But early research suggests stents may work better than those treatments.

"Most patients had significant improvement; for instance, they could go home rather than having to be placed in a nursing home, which is pretty dramatic," said L. Nelson Hopkins, M.D., professor and chairman of neurosurgery and professor of radiology at the State University of New York at Buffalo, who is presenting the data at ISET. "Stents seem to work when clot-busters or other mechanical devices can't."

The third-leading cause of death in the U.S., stroke is called a brain attack because blood flow and oxygen to part of the brain is cut off. About 85 percent of strokes are ischemic, meaning they're caused by a blocked blood vessel. About 700,000 people suffer an ischemic stroke every year. The remaining 15 percent of strokes are hemorrhagic and are caused by a broken blood vessel. The lack of blood flow and oxygen to the site of the stroke causes the brain tissue to die. About a quarter of people who suffer a stroke die. Another third are severely disabled and may be paralyzed or lose the ability to speak or remember.

SUNY Buffalo researchers are reporting preliminary results on 16 patients who received stents to treat their strokes as part of a single center Investigational Device Exemption (IDE) from the FDA, with Elad Levy, M.D., as the principal investigator. Stents were placed and opened blocked arteries in the brain in all patients (100 percent) and 11 patients (69 percent) had significant improvement in their stroke symptoms.

Clot-busting drugs only work about half of the time because the blockage can be sticky and adhere to the wall of the artery, making it difficult to break up, said Dr. Hopkins.

Researchers used computed tomography (CT) perfusion to determine if the use of a stent would be beneficial. "With CT perfusion we can tell if the brain is dead or alive," said Dr. Hopkins. "Some patients experience brain death within an hour; others can have a viable brain 24 hours after the stroke starts." In those cases, it may still be possible to place a stent.

Tiny cage-like cylinders, stents are placed minimally invasively by threading a small tube, or catheter, through the arteries to the site of the blockage. A tiny balloon is inflated to open up the blockage. A collapsed stent is then placed at the site, where it expands and acts like scaffolding to keep the artery open.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.

"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."

More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.

Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance, which has benefited from the July 2008 recommendation from FDA's Endocrinologic and Metabolic Drugs Advisory Committee.

The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. The FDA is continuing to evaluate how today's recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.

The FDA's guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director, CDER, FDA.

"Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on FDA's website at http://www.fda.gov/cder/guidance/8576fnl.pdf. It will be published in the Federal Register on December 19, 2008. In addition, the FDA has provided written notice of the recommendations from this guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Daily Rhythms in Blood Vessels May Explain Morning Peak in Heart Attacks

It’s not just the stress of going to work. Daily rhythms in the activity of cells that line blood vessels may help explain why heart attacks and strokes occur most often in early morning hours, researchers from Emory University School of Medicine have found.

Endothelial cells serve as the interface between the blood and the arteries, controlling arterial tone and helping to prevent clots that lead to strokes and heart attacks, says Ibhar Al Mheid, MD, a postdoctoral cardiology researcher at Emory.

He presented his results in a poster session Monday, Nov. 10 at the American Heart Association Scientific Sessions in New Orleans.

“One of the important ways the lining of our blood vessels is maintained is by progenitor cells that come from the bone marrow,” Al Mheid says. “These are essentially stem cells that help replace endothelial cells at sites of injury and build new vessels at sites deprived of adequate blood supply. The aim of our research was to look at the circadian pattern of both endothelial function -- the ability of blood vessels to relax -- and the abundance of the progenitor cells.”

Working with Arshed Quyyumi, MD, professor of medicine and director of the Emory Cardiovascular Research Group, and colleagues, Al Mheid examined a dozen healthy middle-aged subjects every four hours for 24 hours. They drew blood while the subjects were asleep at 4 a.m. Blood vessel relaxation is assessed by cuff occlusion, a standard technique in measuring blood pressure – and was not measured at 4 a.m.

The researchers measured the ability of subjects’ blood vessels to relax, the abundance of endothelial progenitor cells (EPCs) and their ability to grow in culture. Both the ability of blood vessels to relax and EPCs’ ability to grow peaked (roughly 40 percent more than the middle of the day) at midnight, while cell numbers peaked at 8 p.m.

“The lining of our vessels appears to function better at night than in the day. Endothelial function is particularly depressed in the early morning hours,” Al Mheid says.

He hypothesizes that an innate circadian timer in the brain, which other scientists have shown to be influenced by light and dark and daily activities, drives the cyclical variations in EPCs and endothelial function.

About Emory Heart & Vascular Center Emory Heart & Vascular Center doctors are committed to providing clinically excellent cardiovascular patient care, pioneering innovative clinical research and training the best heart specialists in the world. A component of Emory Healthcare, the Center is consistently recognized by U.S. News & World Report as one of the top heart centers in the country. Emory Healthcare is the clinical arm of Emory University's Woodruff Health Sciences Center and is the largest, most comprehensive health care system in Georgia.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page