FDA warns, then withdraws letter over combining vitamin C and Vicks cough-cold formulations
NEW YORK Make no mistake, this Food and Drug Administration has shown time and time again this year that it has taken a shoot-first, ask-questions-later approach to ensuring the safety of the products it regulates. The FDA, in a news release, stated that the warning letter was posted due to an internal systems error, and in fact no warning had been sent to Procter & Gamble.
Yet. Because the letter was still written, and that fact can’t be explained away by an internal systems error.
While no Drug Store News source has stated anything either on-the-record or for attribution, this new FDA has many in the OTC industry concerned. It started with the voluntary withdrawal of the majority of Hydroxycut SKUs based on some 30 adverse event reports. Then came the highly publicized voluntary withdrawal of three Zicam cough-cold products because of some 130 cases of a loss of smell allegedly associated with the use of Zicam over the course of 10 years in a population that is predisposed to that loss of smell. Following that, the FDA announced that because of three potential adverse events in the United States, it was keeping tabs on potential liver damage around the use of the weight-loss drug alli.
The legitimate concern among OTC suppliers is simply — can they be next?
Walgreens relaunches Health Corner Web site
MILWAUKEE Walgreens unveiled Thursday the new and improved Healthcornertv.com, an innovative, easy-to-browse Web site with more than 1,200 videos on 65 health-and-wellness topics.
The new Web site presents health-and-wellness information through the use of high quality videos featuring real people managing common medical conditions. Healthcare experts share valuable tips and advice for maintaining a healthy, active lifestyle.
“What sets Healthcornertv.com apart from other online resources is the compelling, engaging way it presents the most current, relevant health-and-wellness information,” says Connie Splitt, Walgreens media production manager, and director of the new Web site’s content. “The videos and tools offer a more user-friendly alternative to endless articles and research. The site was designed to empower and inspire people to make healthy choices for themselves and their families.”
Healthcornertv.com videos span a broad range of topics from acne, allergies and Alzheimer’s to heart disease, diabetes and beyond. In addition to management and treatment, a major focus of the site is prevention and lifestyle, with hundreds of features on cooking with functional foods, fitness and exercise.
Celebrity interviews are also featured, including Sally Field on osteoporosis, Suzanne Somers on anti-aging, Jamie Lee Curtis on gastrointestinal health and Patti Labelle on diabetes. The Web site also offers quick links to other valuable online resources including the latest research findings from the Centers for Disease Control, National Institutes of Health and many more.
Healthcornertv.com is a companion to and extension of the Health Corner television series, sponsored by Walgreens, now in its sixth season airing on Lifetime.
Health Corner, “America’s Healthiest TV Show”, airs Sunday mornings at 9:30 Eastern and Pacific time, 8:30 Central and 10:30 Mountain time on Lifetime Television. A total of 26 episodes per season are produced by Milwaukee-based Marx Creative.
NIH announces government-sponsored clinical trial of H1N1 vaccine
NEW YORK There still is widespread concern over the safety and efficacy of the new H1N1 influenza vaccine, despite public assurances from executives at the highest levels of the Centers for Disease Control and Prevention — the point agency around the H1N1 pandemic — that the H1N1 vaccines have been subject to the same safety and efficacy protocols as seasonal vaccine, which generally is considered both safe and effective.
And the clinical trials that have been published to date show that the H1N1 vaccine, at the 15-microgram dose, works, even among children. Sanofi Pasteur late last week announced that clinical trials of its H1N1 vaccine in infants and children ages 6 months through 9 years was efficacious and only required one dose.
The NIH trial, though, is specifically exploring whether or not a 15-microgram dose provides adequate protection against asthmatics, or people with other upper respiratory chronic diseases, one of the high-priority groups identified by CDC for H1N1 influenza inoculation and a disease-state that may place sufferers at greater risk of complications from influenza. According to the American Lung Association, 7.6 million people in America have been diagnosed with chronic bronchitis; 3.7 million Americans will develop emphysema over the course of their lifetime; 6.7 million children have been diagnosed with pediatric asthma; and 8.4% of all adults report having adult asthma.
It’s important also because the prevalence of H1N1 influenza remains higher than expected influenza levels for this time of year and continues to be on the rise, even this early into the season.
Two weeks ago, a total of 37 states reported widespread influenza activity (which means that more than half of the counties have reported influenza activity)— only Washington, D.C., Hawaii and Vermont reported less than regional influenza activity (regional activity is more than one, but less than half of all counties have reported influenza activity; less than regional activity means only one county has reported influenza activity).