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FDA Requests Labeling Change For Leukotriene Modifiers
The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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Can A Society With Smokers Be Profitable?
The latest rise in the indirect taxation on tobacco and alcohol took place in June. The most popular brand of cigarettes went up in price from 3.10 euros to 3.30 euros per packet. Are these taxes a form of dissuasion or a way of compensating the rest of society for the harm generated by those who smoke? A study by the Polytechnic University of Cartagena has looked into the most significant questions concerning the tobacco economy.
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Smoking In Military Populations, VA Medical Centers: DOD, VA, Congress Should Take Stronger Steps Toward Eliminating Tobacco Use

Because tobacco use impairs military readiness, harms the health of soldiers and veterans, and imposes a substantial financial burden on the departments of Defense and Veterans Affairs, these agencies should implement a comprehensive strategy to achieve the Defense Department"s stated goal of a tobacco-free military, says a new report from the Institute of Medicine. DOD should gradually phase in a ban on tobacco use in the military, starting at military academies and officer training programs and among new recruits, the report says. DOD should also stop selling tobacco products in Army and Air Force commissaries -- Navy and Marine Corps commissaries already do not sell them -- and should stop selling them at a discount in military exchanges and other stores. In addition, Congress should allow VA to establish tobacco-free medical centers. The report was requested by DOD and VA, who asked the Institute of Medicine to identify policies and practices that could lower rates of smoking and help soldiers and veterans quit. Tobacco use reduces soldiers" physical fitness and endurance and is linked to higher rates of absenteeism and lost productivity, the report says. In 2005, 32 percent of active-duty personnel and 22 percent of veterans were smokers; rates among active-duty personnel have recently increased, possibly because of growing tobacco use by deployed troops. "We found that the adverse effects of tobacco use on military readiness, the health of both smokers and nonsmokers, and the financial cost of the medical care of smoking-related illness in military and veteran populations are a sound basis for moving systematically toward a tobacco-free military," said Stuart Bondurant, professor of medicine and dean emeritus of the School of Medicine at the University of North Carolina, Chapel Hill, and chair of the committee that wrote the report. "The state of the art in tobacco control is such that with well-managed programs, DOD and VA could eventually be tobacco free with minimal disruption, and with substantial benefit to military personnel and veterans." DOD and VA should ensure that all personnel have quick and easy access to comprehensive, evidence-based tobacco-cessation services, the report says. All DOD and VA health care providers should be able to provide brief counseling and nicotine-replacement therapy to patients. In addition, the committee recommended that VA and DOD develop toll-free "quitlines" to provide military personnel and veterans with counseling on quitting tobacco. Quitline counselors should be trained to deal with issues related to these populations, such as post-traumatic stress disorder. The Defense Department should set a date by which the military will be tobacco-free and require each of the four services to develop and enforce a timeline for achieving this goal, the report says. Recognizing that immediately banning tobacco use in deployed personnel is not realistic, the committee urged an incremental strategy, starting with closing the pipeline of new tobacco users entering the military. Smoking should be banned at military academies, and the current ban on tobacco use during basic training should be extended to include subseqent technical training. That ban could eventually be extended to all new enlistees, who would be informed during recruitment that they would be expected to remain tobacco-free during their entire military careers. Eventually, all military installations and active-duty personnel should be required to be tobacco-free -- a goal that could realistically be achieved in 20 years or even sooner, if the plan"s initial phase for military academies and new recruits starts within a year, the report says. Only with assistance from DOD and VA will tobacco use be stopped, the report says, and ideally DOD should not sell tobacco products as they inhibit military readiness. As a first step, DOD should prohibit tobacco sales in Army and Air Force commissaries and stop selling tobacco products at a discount in other military stores. Congress should direct DOD to sell any tobacco products in military exchanges at prices equal to those in the civilian sector, and preferably higher. Congressional action is also necessary to allow VA to implement tobacco-free medical facilities. The VA"s efforts to do so have been hampered by the language of the Veterans Health Care Act of 1992, which requires them to maintain smoking areas for veterans and employees. This act should be repealed, the report says. The study was sponsored by the U.S. Department of Veterans Affairs. Copies of Combating Tobacco Use in Military and Veteran Populations are available from http://www.nap.edu. Sara Frueh National Academy of Sciences


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