FDA delays action on Salix drug
RALEIGH, N.C. — The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug’s manufacturer said.
Salix Pharmaceuticals said the FDA was still reviewing its application for crofelemer in the 125-mg strength. The agency was originally expected to take action on the drug Wednesday. Crofelemer is meant for treating noninfectious diarrhea in HIV and AIDS patients taking antiretroviral therapy.
"By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue," Salix EVP medical and research and development and chief development officer Bill Forbes said. "The continuing dialogue should allow further collaboration between us and the agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer as well as to botanical products in general."
Supervalu’s Cub Foods kicks off Hunger Action Month food drive
STILLWATER, Minn. — Supervalu banner Cub Foods, KSTP-TV, MOM Brands, Dr Pepper Snapple Group and Dean Foods on Tuesday announced a partnership to sponsor the Hunger Action Month food drive under the banner "Give a Little, Feed a Lot" during September at all Cub Foods stores in Minnesota.
To officially celebrate the start of Hunger Action Month, the Cub Foods store in Shorewood, Minn., will host a "Dash for Hunger" supermarket race between local dignitaries on Sept. 6 at noon. Participants will race around the store pushing grocery carts and collecting nonperishable food. With only three minutes on the clock, the goal is to collect as much product to benefit families who rely upon the Intercongregational Communities Association Food Shelf for assistance. Cub Foods will donate the equivalent dollar amount of groceries, with two local Rotary clubs matching Cub’s donation dollar for dollar.
Dr Pepper Snapple Group is serving as a primary sponsor of Hunger Action Month. As part of this effort, they are donating $25,000 to Second Harvest Heartland to help families in need.
All proceeds will benefit Second Harvest Heartland and Minnesota’s Feeding America Food Banks, including Channel One Food Bank and Food Shelf, Second Harvest Northern Lakes Food Bank and Second Harvest North Central Food Bank, as well as dozens of local food shelves.
Cub Foods customers and Minnesota residents can support the cause in one of two ways: by purchasing any dry packaged food or a "Community Cupboard Bag" that is already filled with a complete meal and placing it in the specially marked donation bin in the store, or by rounding up their grocery bill to the nearest dollar at the checkout register and donating the change. All food bin donations will benefit local food shelves, and customer cash donations will go to Second Harvest Heartland.
Kimberly-Clark issues consumer advisory on certain lots of tampons
DALLAS — Kimberly-Clark has issued a consumer advisory — as a result of suspected criminal activity — regarding a number of defective lots of Kotex Natural Balance Security tampons that may pose public health risks to consumers.
While the health risk to consumers is low, some of these tampons have: Increased levels of bacteria; presence of metallic particles; or imperfect raw materials.
These products were stolen and fraudulently distributed between Oct. 1, 2011, and June 28, 2012. Distribution locations are unknown at this time. The affected lot codes listed below can be found in the red box located on the bottom of the carton.
Impacted Lot Code List:
Kotex Natural Balance Regular Absorbency Security tampons (18 count) AC209621X and AC209622X; (36 count) AC209625X;
Kotex Natural Balance Super Absorbency Security tampons (36 count) AC127423X, AC209623X, AC209624X;
Kotex Natural Balance Super Plus Absorbency Security tampons (18 count) AC127322X, AC127422X, AC213822X, AC213922X, AC214022X and AC214322X; (36 count) AC127424X, AC206824X and AC207824X.
To date, K-C has received no reports of consumer complaints regarding health issues with the product in question. However, the company is encouraging all consumers to check their Kotex Natural Balance Security tampon cartons for any of the above lot codes.
The company is strongly advising consumers that all products with these lots codes should be considered unsafe and not fit for use. Because the cases have left K-C’s authorized supply chain, the company has no knowledge of the product’s current condition. K-C recommends that any consumer experiencing health concerns regarding the use of tampons should immediately cease using the product and contact their physician.
Consumers should contact K-C at 1-877-485-6839 for instructions on where to send the impacted products in return for a full refund. K-C service representatives will be available seven days a week from 7 a.m. to 7 p.m. Central time. Consumers also can get information by visiting Kotex.com or Kimberly-Vlark.com.
As part of K-C’s ongoing brand and consumer protection activities, the company determined that some of the products scheduled for destruction between October 2011 and June 2012 have been offered for sale. An investigation into this activity is ongoing and now involves the criminal investigation division of the Food and Drug Administration. K-C, in conjunction with the FDA, is continuing efforts to recover the impacted tampons.
K-C and the FDA are asking for the public’s help in reporting any information regarding this situation to the FDA’s Office of Criminal Investigations by calling 1-800-521-5783 or by visiting FDA.gov/OCI.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA online at FDA.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or call the FDA 1-800-FDA-1088.