The FDA approved Prevnar 13 for adults 50 and older to prevent pneumococcal pneumonia and invasive disease, using its accelerated approval pathway. About 300,000 U.S. adults in that age group are hospitalized with pneumococcal pneumonia yearly, an FDA official said.
Section archive
Page 6 of 13
Government
Updates from the FDA, CDC and other agencies.
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Government
The Appalling Betrayals which Illegitimatize this Agency's Views - Why Do You Still Trust Them? (comment)
Dr. Mercola summarizes CDC Off Center, a report produced under Senator Tom Coburn, which accuses the agency of spending hundreds of millions on items such as zero-gravity chairs, saunas and furniture, and notes syphilis rose 68 percent among men after a plan to eliminate it.
Government
Holly Petraeus gets it - email from U.S. vice president
An email from the vice president describing Holly Petraeus's Capitol Hill testimony on predatory lenders targeting military families, and urging readers to press the Senate to confirm Richard Cordray to lead the Consumer Financial Protection Bureau.
Government
How Is Diabetes Treated in Children?
Type 2 diabetes, once mainly an adult disease, is increasingly diagnosed in youths aged 10 to 19, and about one in six children and teens is obese. FDA endocrinologist Ilan Irony says treatment aims at keeping blood glucose in normal range, with no single approach working for everyone.
Government
A Parent's Horrid Nightmare: Coming Soon to YOUR State?
California's AB 499 would let children as young as 12 receive vaccines against sexually transmitted diseases, including Gardasil and hepatitis B, without parental knowledge or consent. Mercola urges readers to call Governor Brown and objects that parents remain liable for any harm.
Government
FDA approves new treatment for lung cancer
FDA granted accelerated approval to crizotinib for ALK-positive advanced or metastatic non-small cell lung cancer, along with a companion test. Across two single-arm trials totaling 255 patients, response rates were 50 and 61 percent, with median response durations of 42 and 48 weeks.
Government
2011 State Sales Tax Holidays
A state-by-state table of 2011 US sales tax holidays, listing each state's number of tax-free days, the items covered, the spending cap per item, the year the holiday began, its dates, and a link to the state revenue department.
Government
MedWatch: Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
The FDA updated the Chantix (varenicline) label to cover the drug's use in people with cardiovascular disease and COPD, and to note that varenicline may carry a small increased risk of certain cardiovascular events in patients who already have cardiovascular disease.
Government
FDA braces for new flu season
FDA approved the 2011-2012 influenza vaccine formulation, which covers the same three strains as the previous season and will be made by six licensed manufacturers. CDC figures put annual US flu illness at 5 to 20 percent of people and over 200,000 hospitalizations.
Government
HUD Emergency Homeowners' Loan Program (EHLP)
An overview of HUD's Emergency Homeowners' Loan Program, funded with $1 billion under Dodd-Frank, and its eligibility rules: a 15 percent income drop from job loss or medical emergency, three months of mortgage delinquency, a foreclosure notice, and the home as a principal residence.
Government
E-HAP Direct Update: National HIV Testing Day
A National HIV Testing Day message notes about 1.2 million Americans live with HIV and more than 200,000 of them, one in five, do not know it. Testing links people to treatment that extends life and prevents transmission; each infection averted saves about $367,000 in medical costs.
Government
New evidence confirms dentists controlled statements by CDC on fluoridation toxicity concerns
A press release from The Lillie Center says Freedom of Information Act documents show only staff of CDC's oral health division have shaped the agency's support for water fluoridation since the 1970s, with no toxicologists or diabetes experts listed among those giving input.
Government
FDA Unveils New Cigarette Health Warnings
FDA unveiled nine color images, each paired with a printed warning, that must appear on every cigarette pack, carton and advertisement by September 2012 under the 2009 Tobacco Control Act. Regulators narrowed 36 candidates using 1,700 comments and an 18,000-person study.
Government
FDA announces new safety recommendations for high-dose simvastatin
The FDA is changing simvastatin's label because the 80 mg dose has been linked to muscle injury, especially in the first 12 months. It should go only to patients already on that dose for a year without muscle toxicity, and new contraindications cover certain drug combinations.
Government
Drug Information Update - FDA Statement on the AIM-HIGH Trial
The FDA says it will review the AIM-HIGH trial, which tested whether adding extended-release niacin to simvastatin lowered major cardiovascular events. It stopped early because niacin added no benefit, and a small, unexplained rise in ischemic stroke was noted.
Government
FDA examines labels on OTC children's acetaminophen
Two FDA advisory committees voted unanimously to add weight- and age-based dosing instructions for children 6 months to 2 years on single-ingredient pediatric acetaminophen labels, for fever reduction but not pain. The FDA says acetaminophen toxicity causes an estimated 400 U.S. deaths a year.
Government
FDA cracks down on hand sanitizers claiming to prevent MRSA infections
The FDA sent warning letters to four companies, including Tec Laboratories and CleanWell, for marketing over-the-counter hand sanitizers with unproven claims that they prevent MRSA infection. Compliance director Deborah Autor says such prevention claims mislead consumers.
Government
FDA Acts to Reduce Harm from Opioid Drugs
The White House released a multi-agency plan on prescription drug abuse that expands state monitoring programs, promotes safe disposal of unused medicines and targets pill mills. The FDA is adding a Risk Evaluation and Mitigation Strategy for all extended-release and long-acting opioids.
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