Carey named nutritional expert for NuVim
PARAMUS, N.J. NuVim on Tuesday named Ruth Carey nutritional expert.
Carey has been a nutrition consultant in private practice and has been a national media spokesperson for brands like Gatorade and Lipton and has worked with brands like Ensure, Nike, The USA Olympic Committee, The Portland Trailblazers and USA Gymnastics. She has appeared on “Good Morning America,” “The Today Show” and The Food Network.
Carey will be helping to promote NuVim, a refrigerated nutrition beverage sold in half-gallon juice cartons in 2,000 supermarkets, including Shoprite, A&P, Giant Eagle, Acme, Giant and more than 300 Wal-Mart supercenters.
NuVim is fortified with NutraFlora, a prebiotic that helps maintain a strong immune system and enhances calcium absorption and digestion. NuVim also contains a level of whey protein concentrate that is known to help muscle flexibility, promote sturdy joints and improve athletic performance, the company stated.
FDA issues nonapprovable letter over Merck’s Mevacor OTC
WHITEHOUSE STATION, N.J. Merck may yet make a fourth attempt at switching its statin Mevacor over-the-counter, but the Food and Drug Administration officially declined its third attempt, the company reported Friday.
The FDA indicated in its letter that it would require a revised label and additional data from Merck in order to gain marketing approval. “We’re evaluating the conditions outlined in the agency’s response to determine a path forward for Mevacor OTC,” stated Edwin Hemwall, Merck president, global OTC regulatory and scientific affairs.
CDC report finds few pediatric emergency visits due to OTC cough-cold medicines
ELK GROVE VILLAGE, Ill. The journal Pediatrics, published by the American Academy of Pediatrics, on Monday afternoon released a Centers for Disease Control and Prevention report finding that a relatively low number of emergency department visits for children under 12 years of age are associated with prescription and over-the-counter cough and cold medicines; and of those, a majority of those visits is due to unsupervised or accidental ingestion by children between the ages of 2 and 5 years.
“This CDC review puts the overall discussion of pediatric cough and cold remedies into perspective by focusing on concrete data that address the real issue. These medicines are safe when used as directed, and this government review underscores the importance of educating consumers—especially those with small children—on the safe use and safekeeping of medicine,” stated Linda Suydam, president of the Consumer Healthcare Products Association.
According to the report, an estimated 7,091 patients nationwide aged 12 years and younger were treated in emergency departments for adverse drug events from cough and cold medications, accounting for 5.7 percent of emergency department visits for all medications in this age group. Almost two-thirds, 64 percent, were for children aged 2 to 5 years. Unsupervised ingestions accounted for 66 percent of estimated emergency department visits, meaning that the child was not necessarily overdosed by their guardian, but happened upon the medicine and consumed it without supervision. “The other third were adults … in general giving an overdose due to a medication problem of some sort,” commented Richard Dart, director of the Rocky Mountain Poison and Drug Center, during a conference call hosted by CHPA at noon today.
“It’s very clear … these really are situations where parents were confused and [either] gave the wrong dosage,” commented Linda Suydam, CHPA president, or inadvertently left the medicines out where curious children could access them. The report underscores two important messages, Suydam said, the need for child-proof packaging and the need for education of appropriate OTC use among parents. The industry is committed to both initiatives, Suydam said. CHPA recently introduced www.otcsafety.org, designed to deliver “parents and healthcare professionals with one message—OTC medicines need to be respected.”
Even then, most children did not require admission or extended observation (93 percent).
The ADA suggested that targeted education against caregivers may help reduce unsupervised ingestions.
The CDC, in the report, expressed concern that if cough/cold medicines for children younger than six were pulled off the market in an effort to reduce those adverse events, parents may be inclined to administer cough and cold medicines indicated for older children, or for adults, anyway. “Even after the recall of products for children aged 2 years, 64 percent of parents responding to a national survey still considered these medications very safe or somewhat safe and 20 percent plan to continue to use OTC cough and cold medication for their children 2 years,” the report read.
Indeed, it may have been this reason that the Food and Drug Administration earlier this month officially declared that cough and cold medicines were not appropriate to administer to children under the age of two, Suydam said.