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The Food and Drug Administration (FDA) wants to withdraw its approval of midodrine hydrochloride, a medication used to treat the low blood pressure condition orthostatic hypotension, because post-approval studies that verify the clinical benefit of the drug have not been done. This is the first time the agency has issued a withdraw proposal for a drug approved under the FDA’s accelerated approval regulations.
The U.S. Department of Justice is seeking to permanently shut down a Brooklyn, New York-based maker of ready-to-eat deli salads, seafood, and cream cheeses. Food and Drug Administration inspectors say that NY Gourmet Salads Inc. has a history of serious non-compliance with federal food safety standards and the presence of potentially deadly bacteria in its processing facilities and foods.
The Food and Drug Administration (FDA) is warning health care professionals and patients about the potential for developing a type of pneumonia when treated with Cubicin (daptomycin), an intravenous antibacterial drug used to treat MRSA and MSSA, serious difficult-to-treat staph infections of the skin and bloodstream. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms include fever, cough, shortness of breath, and difficulty breathing. If not quickly recognized and appropriately managed, esoinophilic pneumonia may lead to progressive respiratory failure and death.
The U.S. Consumer Product Safety Commission (CPSC) is reminding the public, school officials, facilities managers, and municipal and public safety officials with Whitco Company LP stadium light poles to have them inspected by a qualified engineer immediately because these 70- to 135-foot, 1- to 4-ton poles can fracture or crack and fall over, posing a risk of serious injury or death to patrons and bystanders from being hit or crushed. The poles could put hundreds of people at risk if they fall toward a crowded stadium or onto a building.
The suffocation death of a 4-month-old baby who was using a portable baby recliner in a crib has spurred the Consumer Product Safety Commission (CSPC) and Baby Matters, LLC, to recall 30,000 Nap Nannies. The infant was in her harness and found hanging over the side of the recliner, caught between the Nap Nanny and the crib bumper. At least one other infant has become entrapped while using the Nap Nanny in a crib. That infant was also harnessed, fell over the side of the recliner, and was caught between the product and the side of the crib. He suffered a cut to the forehead. Using the product in a crib is contrary to the recliner’s instructions.
Another 21 lots of Tylenol, Motrin and Benadryl are being added to a recall originally issued January 2010 by McNeil Consumer Healthcare as a precaution because the company discovered the drugs were shipped in wooden pallets that had been treated with a fungicide and may cause consumers to become ill. The recall was originally initiated because there were reports that some of medicines had an unusual moldy, musty, or mildew-like odor that in some cases was associated with temporary and non-serious gastrointestinal events.
The herbal weight loss supplement Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” widely distributed on Internet sites such as the Bouncing Bear Botanicals website and at retail outlets such as Sacred Journey in Lawrence, Kansas, has been found to contain ingredients that can cause serious harm to consumers, according to an analysis conducted by the Food and Drug Administration (FDA).
The National Highway Traffic Safety Administration is investigating new reports of sudden unintended acceleration in three separate incidents, but not in Toyota vehicles. This time, the complaints involve acceleration incidents that have occurred in the 2010 Ford Fusion and Mercury Milan.
The Consumer Product Safety Commission (CPSC) has zeroed in on infant/baby walkers as part of its ongoing effort to provide mandatory safety standards on a range of infant and toddler products.
Infant/baby walkers are an enclosed framework on casters or wheels designed to help babies learn to walk. The new standards adopt the voluntary industry standard and include using the actual weight of a walker in calculation to determine the launching distance for the “stair fall” test, specifying equipment used in the “stair fall” test, and adding a parking brake test for walkers equipped with parking brakes.
The U.S. Consumer Products Safety Commission has identified the manufacturers of the Chinese drywall that thousands of homeowners say has ruined their homes and their health. Enough toxic drywall to build 30,000 homes entered U.S. ports from China during the post-Katrina building boom of 2006 and 2007. People in as many as 18 states claim that the drywall has sickened them with a slew of respiratory problems while corroding their homes’ electrical wiring, air conditioning units, and other household systems.
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