FDA: Don't worry, Tamiflu is safe to use FDA issues asthma advisory Hormones not needed by most menopausal women Long-term care alliance: End Medicare confusion CVS becomes AARP featured employer Experts agree on vitamin D's role in bone health Coalition: Don't use supplements against avian flu
FDA: Don't worry, Tamiflu is safe to use
Use of Roche's Tamiflu (oseltamivir phosphate) has resulted in reports of 12 deaths in children and numerous adverse skin events among patients in Japan. However, an FDA advisory committee has concluded that the antiviral drug is safe to use. The committee added that the number of reported deaths in Japan is lower than published rates of mortality in children infected with the flu. Back to top
FDA issues asthma advisory
The FDA has notified manufacturers of Advair Diskus (fluticasone propionate/salmeterol xinafoate, GlaxoSmithKline), Foradil Aerolizer (formoterol fumarate, Novartis), and Serevent Diskus (salmeterol xinafoate, GlaxoSmithKline) that it proposes to update their existing product labels with new warnings and a Medication Guide for patients. These steps are designed to alert healthcare professionals and patients that these medicines may increase the chance of severe asthma episodes and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled. In response, GSK said it disagrees with FDA's proposal since it conflicts with NIH's treatment guidelines and standard of care for asthma. For more information on FDA's proposal, visit www.CRBestBuyDrugs.org. Back to top
Long-term care alliance: End Medicare confusion
The Long Term Care Pharmacy Alliance (LTCPA) recently sent a letter to the President and Congress urging a change in Medicare rules that currently prevent nursing home staff and pharmacists from counseling seniors about which of dozens of Medicare drug plans best serve their needs. Under current regulatory guidelines issued by CMS, which administers the new drug benefit, nursing home staff and pharmacists are not allowed to help seniors choose the best drug plan for their needs. Instead, the rules direct nursing home caregivers and pharmacists to refer seniors and their families to a CMS Internet plan finder or a toll-free number. Back to top
CVS becomes AARP featured employer
CVS/pharmacy announced that it is joining with AARP to help employ Americans age 50 and over who want to remain or return to the workforce. As a participant in AARP's Featured Employers program, CVS will work to attract mature workers looking for an opportunity to continue their careers. Mature job seekers can visit www.cvs.com/aarp for more information. Back to top
Experts agree on vitamin D's role in bone health
The American Medical Women's Association (AMWA) has issued physician recommendations to generate greater understanding of the role of vitamin D in bone health in women and men over 50. The physicians call for an increase in currently recommended vitamin D intake and encouraging individualized treatment in patients. The panel's action points include the following: supplements are recommended as one of the best sources of vitamin D, and current daily vitamin D intake requirements for women and men over 50 should be increased to 800 to 1,000 International Units. Back to top
Coalition: Don't use supplements against avian flu
The American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, and National Nutritional Foods Association are warning the public that they do not believe any dietary supplements have been shown to prevent or treat avian flu. Consumers are urged to use caution when they encounter dietary supplement products that claim to treat or prevent the avian flu. Back to top
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.