Worth Noting Campaign Aims to Prevent Pregnancy Risks from Acne Drug March 1 is the startup date for a program to educate women about the risk of becoming pregnant while taking the drug Accutane and its generics. The federal Food and Drug Administration (FDA) says it is working with the manufacturers of the drug and its vendor to maintain "a critical balance" between protecting access to the drug by patients who need it and insuring that it is used safely. Isotretinoin, the active ingredient in Accutane, is used to treat severe recalcitrant nodular acne but carries significant risk of birth defects if taken during pregnancy, the FDA points out. The new education campaign, called iPledge, is asking prescribers, wholesalers, and pharmacies to inform women ofchildbearing age about the risks of taking Accutane and to require consent forms and pregnancy testing before providing the drug. Information about the iPledge program is available at www.ipledgeprogram.com. FDA Approves Generic Version of Flonase The manufacturer of a generic version of the popular allergy spray Flonase began shipping the generic to pharmacies in February after the federal Food and Drug Administration (FDA) approved a generic version for sale in the United States. The FDA, which has been under criticism for reputedly dragging its feet on approving generic drugs in general, called an unprecedented news conference to announce its decision on Flonase, which is manufactured by the British pharmaceutical giant GlaxoSmithKline. Under the FDA's procedures, companies can apply to market generic forms of drugs after patent protections for the original drugs expire, a process that can take many months. In the case of Flonase, described as "one of the most popular drugs in the world," GlaxoSmithKline stands to lose at least part of $1.14 billion in annual sales of the drug; the introduction of a generic version of any drug usually causes the price of the brand-named drug to tumble as much as 90 percent. March is School Breakfast Month The School Nutrition Association (SNA), which represents school food service directors around the country, has invited schools to celebrate National School Breakfast Week, March 6 through10. The SNA launched the annual event in 1989 to call attention to the availability of breakfast for students at school and the link between eating a good breakfast and cognitive growth. A survey by the Food Research and Action Center (FRAC) found that a record 9.2 million children participated the federally subsidized breakfast program in the 2004-2005 school year, and the SNA claims that 70 percent of school districts are making some effort at offering breakfast. Resources to help plan special breakfast events in schools are available at www.schoolnutrition.org/nsbw. The following information appeared during the month of February 2006 in the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org. February 8, 2006 A major eight-year study in which women either ate a low-fat diet or ate whatever they pleased reported today that the low-fat diet did not seem to protect the postmenopausal women from breast or colorectal cancer, cardiovascular disease, coronary heart disease, or stroke. The study did not question, however, that there may be other health benefits from a reduction in dietary fats, particularly the saturated fats found in many meats and the trans-fats that are common in processed foods. Considered a gold standard among clinical trials, the long-running Women's Health Initiative Dietary Modification Trial advised women in the low-fat group to reduce total fat intake to 20 percent of energy and to consume at least 5 servings of fruits and vegetables and 6 serving of grains daily. Results of the study were published in today's issue of the Journal of the American Medical Association. February 9, 2006 The federal Substance Abuse and Mental Health Services Administration (SAMHSA) announced today that up to $33 million is being made available to governors' offices in 12 to 15 states for programs that prevent the onset and reduce the progression of substance abuse, including childhood and underage drinking. A minimum of 85 percent of a state's grant must be allocated to community-level organizations for community activities. Details about eligible states and how to apply are available from www.samhsa.gov. States are cautioned that the deadline for applying for these grants is May 1. February 10, 2006 An advisory panel to the federal Food and Drug Administration (FDA) said yesterday it is recommending that the FDA require manufacturers of widely prescribed stimulants for attention deficit and hyperactivity disorder such as Ritalin, Adderall, and Concerta to place the most serious type of warning on the drugs, to indicate they may increase the risk of strokes and cardiac arrhythmias in children and adults. The advisors cited reports of sudden deaths of people taking the drugs and suggested the stimulants may increase heart risks more than two-fold. Stimulants are widely used to reduce childhood behavioral problems such as attention deficit hyperactivity disorder (ADHD) and are increasingly being prescribed for adults; data presented to the advisory panel suggested that 2.5 million children and 1.5 million adults currently take them. Members of the advisory panel apparently agreed that a "black box" warning might prompt families to explore behavioral treatments as an alternative to drugs in controlling childhood ADHD, and they agreed that parents of children with pre-existing heart conditions should consult their doctors before giving stimulants. The FDA is not required to implement the recommendations of its advisory panels, but usually does so. FDA officials were said, however, to be "taken aback" by yesterday's recommendations, and it was not clear whether the suggested actions would be taken. February 10, 2006 Currently, fewer than half of healthcare workers get annual vaccinations for seasonal influenza, and that poses health risks to their patients, the federal Centers for Disease Control and Prevention (CDC) said February 9. In "enhanced recommendations" announced yesterday, the CDC's Healthcare Infection Control Practices Advisory Committee and the Advisory Committee on Immunization Practices are recommending that flu shots be offered at healthcare workplaces during all shifts and at no cost to employees, and that healthcare workers be given information "to combat fears and misconceptions about influenza and influenza vaccines." It's also suggested that employers get a signed form from staff who decline vaccination for reasons other than medical, as a way of identifying and overcoming employees' concerns. The CDC has recommended since 1984 that healthcare personnel be vaccinated annually against influenza, and past influenza outbreaks in hospitals and long-term care facilities have been associated with low vaccination rates among staff. February 16, 2006 The Alliance for a Healthier Generation, a collaboration between the William J. Clinton Foundation and the American Heart Association, announced this week that the Robert Wood Johnson Foundation is providing an $8 million grant to support a new program aimed at helping schools address student overweight and obesity. The Healthy Schools Program will initially make grants to approximately 300 schools in 12 states, with emphasis on schools with limited resources that serve children of disadvantaged economic status. The program will help the schools develop wellness plans; will help them work with stakeholders such as school boards, teacher unions, and PTAs to implement the programs; and will provide curriculum materials on good nutrition and physical activity. Goals of the Healthy Schools Program will include improving the nutritional value of food served in and out of cafeterias, increasing physical activity during the school day and after school, implementing classroom lessons on healthy lifestyles, and developing staff wellness programs. Announcing the new program, former President Bill Clinton said, "Every school day, 54 million young people attend nearly 123,000 schools across the country. Influencing and enhancing the ability of schools to provide environments could be one of the most effective ways to shape the health, education, and well-being of our next generation." Applications for the Healthy Schools Program will be available beginning July 1, 2006, at www.healthiergeneration.org. Additional information is available at www.rwjf.org. February 21, 2006 The United States Supreme Court said today that the justices will hear arguments in a case to decide whether the federal government can constitutionally ban second- or third-trimester abortions in which a fetus is partially removed from the womb and the skull is punctured or crushed. The Partial-Birth Abortion Ban Act was enacted several years ago but has never gone into effect because a number of federal courts have declared it to be unconstitutional. The case now before the Supreme Court, Gonzales v. Carhart, was brought by doctors in Nebraska who perform the procedure and argue that it is the safest method of abortion when the mother's health is threatened by heart disease, high blood pressure, or cancer. Fifteen states-Alabama, Arkansas, Colorado, Florida, Idaho, Kansas, Michigan, Missouri, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Utah, and Virginia-joined in asking the Supreme Court to review the case. February 23, 2006 At a meeting to determine immunization practices for the coming influenza season, the Advisory Committee on Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC) recommended February 3 that influenza vaccination be routine for all children up to five years of age and for anyone who cares for children of that age, either at home or out-of-home. That would replace previous ACIP recommendations that called for flu shots for infants under the age of two. The new schedule is expected to reduce use of health care and lost work time by parents, and since children are principally responsible for spreading the flu virus, it's hoped that keeping young children well may help to curb the disease. Adding children up to age five to the pool of potential flu vaccine recipients would require 20 million to 30 million more doses of the vaccine, if all eligible children were vaccinated, but the ACIP points out that in last year's flu season, slightly less than half of children up to age two were actually immunized. Vaccination makers have told the government they can make 100 million to 120 million doses next season. In today's announcement, the CDC stressed that vaccination is strongly recommended for children of all ages who have chronic medical conditions such as asthma, diabetes, kidney disease, or weakened immune systems. Children under nine years of age who are receiving the influenza vaccine for the first time should receive two doses. The 2006-2007 flu vaccine will contain two new strains, an A/Wisconsin/67/2005(H3N2)-like virus and a B/Malaysia/2506/2004-like virus. One strain from the 2005-2006 vaccine, the A/New Caledonia/20/99(H1N1)-like virus strain will remain in the upcoming vaccine. |
