FDA issues warning about MOM Enterprises’ nursing aid
ROCKVILLE, Md. The Food and Drug Administration on Friday warned consumers not to use or purchase Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.
The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, chlorphenesin and phenoxyethanol contained in the product may be harmful to nursing infants. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.
Mothers and caregivers should watch for a decrease in an infant’s appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant’s strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.
“The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects,” stated Janet Woodcock, director, FDA’s Center for Drug Evaluation and Research. “Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants.”
Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.
Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.
According to the FDA, MOM Enterprises has stated that it has discontinued marketing the nipple cream.
AHA recommends home blood pressure kits
DALLAS Hold on to your cuffs. Sales of blood pressure monitors may soon spike. The American Heart Association on Thursday advocated that people with hypertension should routinely monitor their blood pressure at home to help manage the disease, as part of a joint scientific statement from AHA, American Society of Hypertension and the Preventive Cardiovascular Nurses’ Association.
“High blood pressure is notoriously difficult to treat to goal—many patients fail to reach target levels despite treatment, and studies show home monitoring can help,” stated Thomas Pickering, chair of the statement writing group. “Blood pressure measurement and tracking could be improved with home monitoring by the patients themselves, in much the way people with diabetes monitor their blood sugar levels with home glucose monitors.”
He said there is strong evidence that the traditional way of measuring blood pressure in adults can be misleading. Studies indicate that between 10 percent and 20 percent of people diagnosed with high blood pressure in the doctor’s office actually have the ‘white coat effect,’ meaning that their pressures are normal under other conditions, but rise in the medical setting.
“It is also believed that some people with normal blood pressures in their doctors’ offices have pressures that spike to potentially dangerous levels in other situations,” Pickering said.
According to the statement, home monitoring is particularly useful in the elderly, in whom both blood pressure variability and the white coat effect are increased, as well as in patients with diabetes, patients with kidney disease and in pregnant women.
Retailers look to increase interaction with OTC marketers
LITTLE FALLS, N.J. U.S. drug retailers are looking for a more interactive relationship with over-the-counter drug marketers and have indentified “gold standards” to help define that marketer/retailer relationship, based on communication and sales support, according to the latest research from research firm Kline & Co.
According to Kline’s U.S. Retailers’ Perceptions of OTC Drug Marketers 2008, while most marketers earn high points for product quality and performance, retailers would like to see more in the way of category leadership and a more hands-on approach at the store level.
”Most of the store-level managers we spoke with said they felt left out when it comes to the sharing of market and consumer insights, and that most of this takes place at the corporate level,” stated Laura Mahecha, industry manager of the Healthcare practice for Kline’s research group.
In addition to more local-level interaction, retailers identified other key attributes that make up the gold standard for retailer/OTC marketer relationships. These include having a better appreciation for the retailer’s business, valuing personal relationships, and fostering brand awareness among consumers to help keep products moving off the shelf.
“This gold standard list is enlightening because these were unprompted responses from the retailers,” Mahecha said. “These were open-ended feedback opportunities and the data we collected reveals what they really want.”
To gather the most up-to-date responses, Kline interviewed more than 300 executives and managers from drug stores, food stores, mass merchandisers, and other retail channels from February through April of this year. The data represents feedback from leaders in each channel, including drug stores such as CVS, Rite-Aid, and Walgreens; mass merchandisers Wal-Mart, Target, and K-Mart; food stores such as Food Lion, Kroger, and Safeway; and other outlets including Costco, Sam’s Club, Family Dollar and drugstore.com.