FDA calls for new warnings on anti-inflammatory drug labels
BETHESDA, Md. The Food and Drug Administration on Friday issued a final rule to require important new organ-specific warnings and related labeling for over-the-counter acetaminophen and other nonsteroidal anti-inflammatory drugs, to be published in the Federal Register Jan. 26.
The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using NSAIDs and applies to both medicines marketed under monograph, as well as those approved through a new drug application.
The rule will become effective Jan. 26, 2010, including products with annual sales less than $25,000.
Pharmacy groups laud efforts to stop regulations to limit access to durable medical equipment
ALEXANDRIA, Va. Several pharmacy groups on Thursday lauded the introduction of legislation by Reps. Marion Berry, D-Ark., and Jerry Moran, R-Kan., to stop regulations that could limit Medicare beneficiaries’ access to durable medical equipment from neighborhood pharmacies.
“As the most accessible healthcare providers, pharmacies and pharmacists play a crucial role in the management of chronic diseases, such as diabetes, and are an essential provider of diabetic supplies and Medicare Part B medications,” stated Steven Anderson, president and CEO of the National Association of Chain Drug Stores. “We appreciate the efforts of Reps. Berry and Moran to help prevent the implementation of regulations that may threaten patients’ access to the crucial supplies and equipment to manage their diseases effectively.”
The term “durable medical equipment” includes product categories as diverse as wheelchairs and oxygen tanks, but also includes diabetes equipment and the related supplies—blood-testing strips and blood glucose monitors.
The proposed legislation would exempt pharmacy suppliers from accreditation requirements for the Medicare Part B durable medical equipment, prosthetics, orthotics and supplies program by including pharmacists and pharmacies in the list of health care providers that CMS has already exempt from meeting the quality standards for DMEPOS accreditation.
According to the pharmacy groups, there are significant costs associated with the accreditation process that can create significant financial barriers for pharmacies and pharmacists that are already state-licensed. To date, the regional Ohio drug store chain Discount Drug Mart is one of the few pharmacies to go through the accreditation process.
For those pharmacy operations that decide not to bear those costs, the accreditation process poses a threat to patients’ access to DME supplies and counseling from their pharmacist.
The pharmacy advocate groups supporting the legislation include: The American Pharmacists Association; Food Marketing Institute; National Association of Chain Drug Stores; National Community Pharmacists Association; and the National Alliance of State Pharmacy Associations.
Lansinoh acquires Soothies Gel Pads
ALEXANDRIA, Va. Lansinoh Laboratories on Thursday announced the acquisition of Soothies Gel Pads distributed by Puronyx. The acquisition helps expand Lansinoh product line in an effort to become the turnkey brand offering for breastfeeding mothers.
“We will continue to expand our product line through selective acquisitions and internal development to make certain we have a best-in-class product in every category for breastfeeding mothers,” stated Gary Downing, Lansinoh CEO. “Every breastfeeding mother has her own individual needs and preferences. Some mothers will prefer our Lansinoh HPA Lanolin ointment; some will prefer our Soothies Gel Pads. Other moms will prefer to use our gel pads in conjunction with our HPA Lanolin. Whatever their preference, they’ll be able to satisfy it with Lansinoh products.”
Soothies are the natural feeding segment’s bestselling gel pads, Lansinoh stated, and are used by breastfeeding mothers to cool, soothe, and treat sore nipples that can result from breastfeeding. Soothies Gel Pads will be folded into the Lansinoh portfolio of products, and sold nationally as “Soothies by Lansinoh Gel Pads” at a suggested retail price of $12.99.
In 2008, the breast therapies segment, which includes gel pads and topical ointments, contributed nearly 12% to nursing accessories, which is valued at over $83 million, according to Information Resources, Inc. data, as provided by Lansinoh.
In the U.S., the market for breastfeeding products and accessories has grown 40% since 2005, according to IRI. The birth rate in the U.S. has increased to 4.3 million in 2007, up 4% since 2003, according to the Centers for Disease Control. As many as 77% of mothers now initiate breastfeeding, according to the CDC, the highest initiation rate historically in the U.S.
Nursing mothers experiencing nipple pain or discomfort apply Soothies by peeling off the adhesive backing, and placing the three-inch circular hydrogel pad directly over the affected nipple. Soothies’ hydrogel technology and the science of moist wound healing provide instant cooling relief, and soothes sore, cracked, chapped or chafed nipples. Soothies are also the only gel pad that features fabric backing that reduces or eliminates friction against nursing bras or shirts.