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Manufacturers of Ambien, as well as certain other medications containing zolpidem, were ordered Thursday by the U.S. Food and Drug Administration to lower the recommended dose by half — for women.
The FDA asserts that "zolpidem doses for women and men should be different because women eliminate zolpidem from their bodies at a slower rate than men."
Ambien, Ambien CR, Edluar, Zolpimist — and their generic forms — were named in the FDA's safety annoucement, "Risk of next-morning impairment after use of insomnia drugs."
Patients should be informed, they say, that impairment of mental alertness from sleep drugs can be present the morning after use, despite feeling fully awake.
Doses will be lowered from 10 milligrams to 5 milligrams for regular products. For extended-release formulations, doses will be lowered from 12.5 milligrams to 6.25 milligrams.
The order follows new research that suggest next-morning drug levels in the bloodstream are present in high enough concentration to potentially interfere with driving.
Photo by Bill Keaggy via Flickr Creative Commons
76 types of peanut butter and almond butter have been folded into a recall that sent Creamy Salted Valencia Peanut Butter flying off the shelves at Trader Joe's on Saturday -- the FDA and CDC linked 29 salmonella illnesses in 18 states to that product.
None of the other peanut or almond butters being recalled have been linked to illnesses. New Mexico-based Sunland, Inc. recalled the foods because they were manufactured with the same equipment as the Trader Joe's product, according to a company spokeswoman.
The products were distributed nationally to a number of large supermarket chains. This recall applies to the products with Best-If-Used-By Dates between May 1, 2013 and September 24, 2013.
Consumers who have purchased products with the below UPC codes and Best-If-Used-By-Dates are urged to discard or return the product immediately.
Screenshot via taproduce.com
California is one of the states on alert for a voluntary recall of more than two thousand cases of potentially contaminated lettuce in the U.S. and Canada.
In consultation with the U.S. Food and Drug Administration, and based on testing by the Canadian Food Inspection Agency, Tanimura & Antle Inc. is voluntarily recalling a single lot of romaine lettuce because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).
Details of the recall via FDA -
- Product: Tanimura & Antle Field Fresh Wrapped Single Head Romaine
- Case code: 5417802151 (affixed to the exterior of the case)
- Packaging: Plastic bag
- UPC number: 0-27918-20314-9
- Best Buy date: 08/19/12
- Available at retail locations: Aug. 2 – Aug. 19, 2012.
In total, 2,095 cases of potentially affected product were distributed, beginning August 2. 1,969 cases were shipped to 19 U.S. states and Puerto Rico. No other Tunimura & Antle products are included in this recall. No associated illnesses have been reported.
Two highly questionable feminine products are being recalled by a Los Angeles-based company following the Federal Drug Administration discovery of Staphylococcus bacteria and other pathogens in one product, and the anesthetic benzocaine, in the other.
The products are sold to herbal stores, beauty shops and drug stores by an Alhambra-based company called USA Far Ocean Group Inc. (U.S.A. Far Ocean), that promotes the product with disturbing questions like, "Are you deeply concerned about female diseases?" and "Do you want to get rid of them forever and regain your charm?"
The products, sold also in stores, online and via mail order, are packaged individually as "Vagifresh Ball" and "Vagifresh Gel," and packaged together as "Female One."
FDA lab analysis found that the Vagifresh Gel contained benzocaine, a local anesthetic commonly used as a topical pain reliever, while analysis of the Vagifresh Ball found bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp.