Calcium and Vitamin D Preventing Osteoporosis

FDA Updates Health Claim for Calcium and Osteoporosis Proposal Would Give Consumers More Information to Make Healthy Food Choices The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below. "This is important information for all citizens," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Nutrition. "All persons lose bone with age, and the loss can influence an individual's risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one's risk." Today's action is part of FDA's continued commitment to helping consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, The Coca-Cola Company. The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend this existing health claim by allowing for claims of a reduced risk of osteoporosis with the consumption of both calcium and vitamin D. The proposed rule also would eliminate certain requirements that were a part of the required claim language in the existing calcium and osteoporosis health claim. However, FDA is not changing its conclusion that there is still significant scientific agreement to support claims for calcium intake and reduced risk of osteoporosis. "Osteoporosis is a significant public health problem, especially for women," said Kathleen Uhl, MD, assistant commissioner of FDA's Office of Women's Health. "This new labeling should assist consumers to select foods - and women especially since women do the majority of food shopping in the US - that provide adequate calcium and Vitamin D intake and hopefully prevent the occurrence of osteoporosis in themselves and their family members." FDA's decision to amend the existing health claim is based on the agency's review of the publicly available scientific evidence, which included the 2004 Surgeon General's report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy. Specifically, FDA is proposing to change the calcium and osteoporosis health claim to: Add a claim for calcium and vitamin D together and a reduced risk of osteoporosis. Shorten the claim language by: Dropping the reference to sex, race, and age since the benefits apply to both sexes at all ages and race categories. Dropping the need to identify the mechanism by which calcium reduces the risk of osteoporosis. Dropping the requirement that the claim state that there are limits to benefit of calcium intakes above 200% of the Daily Value.

New OTC Pain Medicine Rules from the FDA

FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers The Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscle aches. To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes: For Products Containing Acetaminophen To require new warnings which would highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol; To require that the ingredient acetaminophen be prominently identified on the product's principal display panel (PDP) of the immediate container, and the outer carton (if applicable). For Products Containing NSAIDs To require new warnings for products that contain an NSAID which would highlight the potential for stomach bleeding in persons over age 60, in persons who have had prior ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for longer time than directed; and To require that the name of the NSAID ingredient and the term "NSAID" be prominently identified on the product's PDP of the immediate container and the outer carton (if applicable). The new labeling would be required for all OTC drug products that contain only an IAAA ingredient, as well as for products that contain an IAAA ingredient with other ingredients, such as cold symptom relievers. Consumers may also be taking IAAA ingredients in their prescription medications, which makes it important to alert them of the contents of their OTC medications, so they do not take too much of an IAAA ingredient. FDA based its proposal for labeling changes on previous Advisory Committee discussions, recommendations, and public comments (see http://www.fda.gov/ohrms/dockets/ac/cder02.htm#NonprescriptionDrugs) and a review of the scientific literature. A number of manufacturers of OTC internal analgesic drug products already have voluntarily implemented labeling changes to identify these potential safety concerns. Comments on the current proposal, to be published in the December 26, 2006 Federal Register may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: (http://www.fda.gov/ohrms/dockets/default.htm ).

Recommended prevention of Avian Flu - WHO

In a nonpandemic situation, recommendations for treatment of patients with confirmed or strongly suspected infection with avian influenza A (H5N1) are as follows: Patients should receive oseltamivir treatment as soon as possible (strong recommendation). Clinicians might administer zanamivir (weak recommendation). If neuraminidase inhibitors are available, clinicians should not administer amantadine alone as a first-line treatment (strong recommendation). If neuraminidase inhibitors are not available and especially if the virus is known or likely to be susceptible, clinicians might administer amantadine as a first-line treatment (weak recommendation). If neuraminidase inhibitors are available, clinicians should not administer rimantadine alone as a first-line treatment (strong recommendation). If neuraminidase inhibitors are not available and especially if the virus is known or likely to be susceptible, clinicians might administer rimantadine as a first-line treatment (weak recommendation). If neuraminidase inhibitors are available and especially if the virus is known or likely to be susceptible, clinicians might administer a combination of neuraminidase inhibitor and M2 inhibitor (weak recommendation). This should only be done in the context of prospective data collection. High-risk exposure groups should receive oseltamivir as chemoprophylaxis continuing for 7 to 10 days after the last known exposure (strong recommendation). In moderate-risk exposure groups, oseltamivir may be administered as chemoprophylaxis, continuing for 7 to 10 days after the last known exposure (weak recommendation). Low-risk exposure groups should probably not receive oseltamivir for chemoprophylaxis (weak recommendation). Additional recommendations address prophylaxis and treatment with other agents and in specific groups including pregnant women. "The greatest barrier to implementation results from the limited availability of the neuraminidase inhibitors and the lack of resistance data," the panel concludes. "Emergence of novel human influenza A viral subtypes or a change in the pathogenicity or transmissibility of H5N1 virus strains, availability of new pharmacological agents, or important clinical research data on H5N1 will necessitate an update of these guidelines. In view of the potential for rapid change in the situation in relation to avian influenza, WHO will continue to monitor these factors carefully before deciding when to revise or update the recommendations. Lancet Infect Dis. 2007;7:21-31.