Walgreens gives customers direction on cough-cold OTC dosing for children
DEERFIELD, Ill. Walgreens has said that it will advise its customers on the proper, safe use of over-the-counter cough and cold remedies by adding in-store signage to shelves and making its pharmacists available for consultations.
After the announcement from the CHPA Tuesday that cough-cold remedies should not be administered to children under age 4, many cough-cold remedy makers are revising their product labels to reflect the new dosing recommendations before the upcoming cold season. Walgreens has made a commitment to make sure the most current labeled cough and cold remedies will be available during the label-upgrading swap, and newly labeled products will be on shelves as soon as they are available.
The FDA has issued a statement that parents should take precautions when administering cough-cold medicines to children, including, checking active ingredients on the Drug Facts product labeling, avoiding given children two products with the same active ingredients at the same time, following directions, using the appropriate measuring instruments, selecting cough-cold medicines with child-proof caps, recognizing that cough-old remedies do not shorten the length of illness but only treat symptoms, not using cough-cold products for sedation and calling a doctor or pharmacist if any adverse reactions occur after administering.
CHPA advises parents not to give cough-cold remedies to infants, toddlers
WOONSOCKET, R.I. The Consumer Healthcare Products Association on Tuesday announced that the industry will voluntarily advise parents not to administer cough-cold medicines to children under the age of four. CHPA members last year voluntarily removed from the market any medicines marketed or merchandised to infants under the age of two; the under-four label change will be sold-through this cough-cold season, however.
CVS/pharmacy released a statement Tuesday morning supporting the label changes. “The health and safety of our customers is our highest priority and we support CHPA’s voluntary action,” stated Michael Bloom, senior vice president of merchandising at CVS/pharmacy. “As pediatric cough and cold medicines have been declared safe and effective by the FDA, it is also important that our customers have access to these products during cough and cold season while our suppliers transition to labels with new pediatric dosing directions.”
CVS/pharmacy is working with its suppliers to ensure that the OTC medicines will be available in its stores with new pediatric dosing directions as quickly as possible, the pharmacy operator stated. In the meantime, CVS will continue to keep the current versions of the 130 products it offers available for customers who rely on these medicines to treat their families’ cold and allergy symptoms.
“Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children,” stated Linda Suydam, president of CHPA. “As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”
CHPA consulted with FDA in the aftermath of last week’s public meeting regarding whether or not several monographed cough/cold medicines were appropriate for use in children under the age of six. After that meeting, the FDA promised action, however acknowledged that that action, in the form of rulemaking, could take several months before a proposed rule change to the governing monographs would be introduced.
In addition to the marketing ban on children under the age of four, CHPA manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy.
Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral OTC pediatric cough and cold medicines with the new labels and packaging. “As with other OTC labeling changes in the past, FDA has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition,” Suydam said.
CHPA has also expanded its national education program aimed at parents, caregivers, and healthcare professionals on appropriate dosing and use of OTC medicines in children.
Probiotics greatly benefit digestive health of children, seniors, research says
WASHINGTON New research on the benefits of probiotics in children and seniors was presented at The American College of Nutrition Annual Meeting in a symposium Monday. Scientific experts in the fields of pediatrics, aging, and nutrition discussed the potential uses for probiotics in children as well as the elderly, and for health conditions such as Inflammatory Bowel Disease.
“Infants don’t have all of their gut bacteria at birth as they acquire it up until about 2 years of age,” stated Allan Walker, professor of Nutrition and Pediatrics at Harvard Medical School, as part of a panel of speakers in summarizing the role of probiotics in pediatrics.
Mary Ellen Sanders, a consultant specializing in probiotics, provided an overview of the studies showing the benefits of probiotics and health. She said, “compelling new studies are showing how probiotics can help keep healthy people healthy. One study showed a decreased incidence of common infectious diseases among kids in day care.” She stressed the fact that each individual strain of probiotic can act differently, so a probiotic that helps with digestion may be different from one that supports the immune system.
Stefano Guandalini, professor of Pediatrics and director of the University of Chicago Celiac Disease Center shared the newest research on probiotics and inflammatory bowel disease. “Inflammatory bowel disease is a condition that affects approximately 1 million adults and 150,000 children in the U.S. Emerging studies are showing promise in children and will continue to help determine how we can be using probiotics practically for such serious conditions.”
About 70 percent of our body’s immune system is located in the digestive tract and as we age, our immune function weakens, added Simin Meydani, associate director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. “The idea is that taking in certain probiotics on a regular basis might positively change the bacterial populations in the gut in older people,” she said.
Under normal circumstances in our gastrointestinal systems, there are many more “friendly” bacteria than “bad” bacteria. If this balance shifts, however, the functioning of the gastrointestinal tract may be affected. Research suggests that adding probiotics to the diet can help optimize the functioning of the intestinal lining, as well as, the immune system, researchers noted.
A Webcast of the symposium will be made available at http://nutrition.med.harvard.edu/, www.usprobiotics.org, and www.americancollegeofnutrition.org.