Using data collected from the National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Study (ICAS), researchers found that inner city asthmatic children might beat greater risk to air pollution at levels below those at current air quality standards.  The study analyzes the short-term effects of outdoor pollution levels on asthma symptoms and lung function in children.

Researchers examined 861 children with persistent asthma, aged five to 12 years, living in low-income areas in seven U.S. inner-city communities:  Boston, the Bronx, Chicago, Dallas, New York City, Seattle, and Tucson.  Over two years, the children’s asthma symptoms, breathing function, and school absences were regularly monitored.  Researchers also obtained daily outdoor pollution measurements from the Environmental Protection Agency’s (EPA) Aerometric Information Retrieval System and—every six months—tested lung function two times each day over a two-week period.  Researchers also asked the children’s parents for their observations of their children’s symptoms. More Air Pollution Hurting Inner-City Kids with Asthma

Federal regulators have received 140 complaint letters about LASIK and Food & Drug Administration (FDA) advisers are recommending the FDA clarify LASIK warnings.  LASIK—laser-assisted in situ keratomileusis—involves cut a flap in the cornea, via laser, for corneal reshaping with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism.  There are no guarantees of 20/20 vision and long-term safety remains unknown.

LASIK is not for everyone, especially those with misshapen or excessively thin cornea, early cataract formation, big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis.  LASIK risks include lost vision, painful dry eye, glare, and night-vision problems.  Serious complications affect about one percent of the cases and FDA estimates place customer dissatisfaction at five percent.   Aggressive marketing makes patients falsely believe clear sight is guaranteed, complained Dr. Jayne Weiss of Detroit’s Kresge Eye Institute, who chaired the FDA advisory panel. More LASIK Worries Prompt Discussion of Alternatives

The Food & Drug Administration (FDA) is finally looking into concerns about the safety of bisphenol A—BPA—a chemical that imitates the hormone estrogen and which is found in polycarbonate plastic.  BPA is found in some baby bottles; water bottles; some food and drink packaging; epoxy resins, which line some metal products including canned foods; dental sealants, CDs and DVDs, eyeglasses, and hundreds of household goods.  Over 90 percent of Americans are exposed to BPA, according to the Centers for Disease Control and Prevention (CDC) and BPA has been found in the urine of 95% of Americans tested.

The FDA just formed an agency-wide BPA task force to review concerns noted in a “Bisphenol A Draft Report” recently issued by scientists from the National Toxicology Program and in a separate risk assessment by Canadian health officials.  The FDA states that based on its ongoing review, “we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. However, we will continue to consider new research and information as they become available.” More FDA to Investigate BPA

Early last week, over 450 people reported they were stricken with food poisoning after eating at the Chipotle Mexican Grill in Kent, Ohio.  That city’s health department sent food and biological samples from sick customers to the Ohio Department of Health in Columbus.  Food tests from the Chipotle Mexican Grill did not confirm the virus’ origin; however, investigators confirmed they collected sufficient information to state that norovirus is to blame.

Last week, city Health Commissioner John Ferlito said that Ohio Department of Health tests of stool samples came back positive for norovirus.  ”It was definitely a norovirus outbreak,” Ferlito said Monday. ”It looks like people ingested it through the food.  How it got into the food, I can’t ascertain at this moment.”  Results of the food tests came up negative for fecal coliform, a bacteria often found in human waste, Ferlito said and Ohio Department of Health spokesman Kristopher Weiss said there is no specific test for norovirus in food. More Norovirus Chipotle Mexican Grill Food Poisoning

Blood substitute clinical trials and the blood substitutes themselves are under fire.  Apparently, some of the experimental blood substitutes being trested can significantly raise the risk of heart attack and sudden death according to regulators who also said that their use in new experiments should be stopped until safety issues have been cleared up.  In an unprecedented pairing, health advocates and federal government researchers teamed up in a joint study.  The study of blood substitutes revealed that the Food and Drug Administration’s (FDA) confidential oversight of corporate research was putting patients at risk.  The groups called for both an end to trials of the blood replacement products and an overhaul of the FDA’s requirements to keep corporate secrets.

The study reviewed various trials of five blood substitutes and revealed a 30 percent increased risk of death and a 2.7 times higher risk of heart attack, according to researchers report in the  Journal of the American Medical Association.  All of the blood substitutes use hemoglobin.  Hemoglobin is the molecule that transports oxygen in red blood cells. More FDA Blasted Over Blood Substitute Deaths

Avandia, a diabetes drug already mired in controversy, may double the risk of bone fractures, according to a new study. The study, conducted by Swiss researchers, found a similar risk with the diabetes drug Actos. Previous studies have found that these drugs increase the risk of bone fractures, but the Swiss study sheds light on how serious this problem might be.

Avandia has been a subject of debate since last May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Last July, the Food & Drug Administration (FDA) convened a panel to discuss the issues surrounding Avandia’s heart attack risk. The panel voted 20-3 that the drug did in fact raise the chance of heart attacks, yet the panel still voted 22-1 to allow it to remain on the market. In November, the FDA announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks. However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues. These critics continue to call on both GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market. One diabetes expert, Dr. John Buse, has said that in action on Avandia might be responsible for as many as 83,000 preventable heart attacks. More Another Study Confirms Avandia, Actos Bone Fracture Risk

An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators.  The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,

Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest.  Physio-Control stopped U.S. shipments in January 2007 due to quality problems.  Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit.  The consent decree agreement requires court approval. More Medtronic Unit Agrees to Consent Decree

There has been a recent and disturbing increase in the number of children who have fallen ill and died from both the flu and MRSA.  State and federal disease investigators are tracking the situation and Massachusetts’s health authorities have linked two recent childhood flu deaths to the methicillin-resistant Staphylococcus aureus germ, known as MRSA.  Nationally, of the 74 children known to have died from the flu in the United States in 2006-07, 22 also had staph infections.  Most of those staph infections were of the fast-moving, drug resistant MRSA.

Authorities at the U.S. Centers for Disease Control and Prevention (CDC) have expressed deep concern for this issue and are planning on executing a monitoring network for patients co-infected with flu and MRSA during the next flue season.  Experts say that data and other findings could assist doctors in preventing flu-MRSA cases from turning fatal. More Flu-MRSA a Dangerous Combo

Earlier this month, members of Congress asked the Food and Drug Administration (FDA) to move faster in forcing drug companies to include safety-reporting information in their television and radio ads.  Now, drug maker AstraZeneca Plc is urging U.S. lawmakers to revive a program for drug makers who want to voluntarily submit their television commercials for regulatory review.  Congress created the program last year but it has not taken effect and lawmakers failed to give the FDA full authority to collect and spend industry fees that would fund the reviews.

Lawmakers are looking for those “direct-to-consumer” advertisements that appear during nightly news and other broadcasts to include information advising consumers how to report potential drug side effects to the FDA, which tracks drugs’ adverse events and uses reports from doctors and patients to be alerted to potential safety problems with drugs currently on the market.  Because the system is voluntary, FDA scientists are concerned it misses most adverse drug reactions.  “When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing,” said Representative Rosa DeLauro, Democrat-Connecticut, who chairs the House sub-committee controlling the FDA’s budget.  “Consumer reporting is an alarm system,” says Representative Jan Shakowski, Democrat-Illinois. More Drug Maker Asks For FDA Drug Ad Reviews

Actavis Totowa—the former Amide Pharmaceutical, Inc.—has just announced an “all-lots” recall of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as a precautionary measure.  It was discovered that that there was a possibility that tablets with twice the appropriate thickness might have been commercially released, meaning that these tablets may contain twice the approved level of active ingredient than is appropriate.   This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).

Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group.  Actavis has initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use.  The medications are distributed by Mylan Pharmaceuticals, Inc. under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.  Actavis manufactures the products for Mylan, which are distributed by Mylan and UDL under the Bertek and UDL labels; Bertek and UDL are affiliates of Mylan.  Class I recalls are conducted when dangerous or defective products that predictably could cause serious health problems or death are released. More Digitek Tablets Recalled By Actavis Totowa