Study: Misunderstanding of OTC cold product directions common
ELK GROVE VILLAGE, Ill. A study published Tuesday on the journal Pediatrics’ Web site determined that misunderstanding of dosage directions for pediatric over-the-counter cold products is common and could result in harm if medications are not given appropriately.
Researchers, however, used “old” kids cough-cold labeling as part of the study — labeling that advises parents to “consult a physician” in children under the age of 2. Today, kids’ cough-cold medicines advise parents to “not use” any cough-cold product in children under the age of 2; the industry voluntarily removed all products carrying the previous label recommendation from store shelves in fall 2007. And in January 2008, the Food and Drug Administration made it official — no kids’ cough-cold product could be marketed to children under the age of 2.
“While this study focuses on products that are not available, it does shine light on an issue that is still very germane,” commented Heinz Schneider, VP science and medical affairs, Consumer Healthcare Products Association. “In contrast to the artificial scenario created by the study authors who asked a small cohort of caregivers to look only at the front of product packages to determine appropriate use, the makers of OTC medicines want to remind parents to read the entire label before giving any medicine to a child. There is no substitute for reading and following the OTC Drug Facts label. The label provides specific dosing instructions, including when to contact a doctor for more information.”
Researchers interviewed 182 caregivers of infants of less than 1 year in age; 87% were the infants’ mother, the mean education level was 12.5 years and 99% had adequate literacy skills, though only 17% had greater than 9th-grade mathematical skills.
When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children less than 2 years of age. More than 50% of the time, parents stated they would give these OTC products to a 13-month-old child with cold symptoms. Caregivers were influenced by the dosing directions only 47% of the time.
Alcon to extend eye drop product lines
HUENENBERG, Switzerland Alcon recently announced that it is releasing two new line extensions this summer across its Systane Lubricant Eye Drops product line.
The product expansions include a dry eye drop for contact lens wearers and a preservative-free, single unit dose product.
Systane Contacts Lubricating Eye Drops, the new moisturizing drop for contact lens wearers, will be shipped in May and is designed to keep eyes comfortable while wearing contacts.
Systane Ultra Preservative Free Vials will launch in August, the company reported. The dry-eye therapy provides extended protection to the ocular surface and increased comfort from the symptoms of dry eye.
“There are over 60 million Americans who suffer from dry eye, and we know they all have different needs,” stated Elyse Dickerson, product manager for Systane. “Expanding our product offering gives consumers more choices for effectively relieving their symptoms with a product designed for their specific needs.”
CDC calls H1N1 virus ‘homogeneous,’ anticipates vaccine development
ATLANTA The Centers for Disease Control and Prevention announced on Friday that scientists have determined that the various strains of novel H1N1 virus around the world are homogeneous — a factor that makes the development of a vaccine much easier.
“From our analysis, we have confirmed that the novel H1N1 virus likely originated from pigs, based on data that each of the genetic components of this virus are most closely related to corresponding influenza virus genes identified from swine influenza viruses,” commented Nancy Cox, director of the CDC’s influenza division, during a press call on Friday.
Referencing an article published Friday in the journal Science, Cox noted that the new H1N1 viruses are antigenically similar to each other. That is, they react to antibodies in a similar way. They’re rather homogeneous,” she said. “This makes our job of coming up with a reference candidate vaccine virus much, much easier. We see much less variation among these new H1N1 viruses than we do for typical, seasonal influenza viruses.”
Currently, the CDC is working on two vaccines for H1N1. One candidate vaccine virus was created by combining the genes of the novel H1N1 virus that are responsible for eliciting protection to influenza with other parts from other viruses that are needed for high growth in eggs. “That process is called reassortment,” commented Anne Schuchat, director of the CDC’s national center for immunization and respiratory diseases. Also, the CDC and the Federal Drug Administration have created a candidate virus using reverse genetics.
“Here at CDC, we’re performing analysis of the egg-derived and reverse genetics-derived candidate vaccine viruses to make sure that they are able to stimulate optimal immune responses, or that their ability to do that remains intact,” Schuchat said. “And after that work is done, suitable viruses will be sent out to manufacturers. We expect by the end of May that will happen so that they can begin work on developing candidate vaccine seed for production of pilot loss of vaccine.”
As of Monday at 11 a.m., there were 6,764 confirmed cases of H1N1 across 48 states, including 10 deaths. Schuchat estimated on Friday that there may be more than 100,000 active cases in the United States currently.