July 29, 2010
The Food and Drug Administration Thursday warned physicians and patients that the intravenous antibiotic Cubicin can cause life-threatening eosinophilic pneumonia, which is marked by the accumulation of a type of white blood cells called eosinophils in the lungs. Symptoms include fever, cough, shortness of breath and difficulty breathing. Cubicin is the brand name for the generic drug daptomycin, sold by Cubist Pharmaceuticals Inc. It was approved in September 2003 for treating serious skin infections and in 2006 to treat bloodstream infections.
November 16, 2012 |
The Food and Drug Administrationon Friday posted additional adverse event reports connecting two more energy drinks to 53 illnesses, five deaths and two chronic disabilities. The new information comes on the heels of an FDA announcement linking the extremely popular 5-Hour Energy shots to 92 sicknesses and 13 deaths. The latest reports do not prove that the drinks -- Monster Energy and Rockstar Energy -- caused the illnesses or deaths, but rather register the fact that a doctor, family member, or patient believes the product might have played a role.
August 2, 2011 |
A coalition of nearly 30 organizations in the animal agriculture industry sent a letter to the heads of the House and Senate on Tuesday, asking lawmakers not to intervene as the Food and Drug Administration considers whether to approve genetically engineered salmon as food. The letter comes more than a month after the House approved an amendment, by voice acclamation, to an appropriations bill that would strip the FDA of funding to study the salmon. On July 15, members of the House and Senate sent letters to the FDA asking it to abandon its consideration of modified salmon as food, and threatened to propose legislation to bar further study of the fish if the agency does not comply.
February 2, 2012 |
Trace levels of the fungicide carbendazim were discovered in domestic orange juice samples, the Food and Drug Administration reported Thursday. But the FDA said the levels pose no safety risk, and the orange juice will not be recalled. FDA spokeswoman Siobhan DeLancey said that most of the samples taken were from concentrated products that will be blended down into the orange juice consumers drink, so the low levels of carbendazim will almost disappear. “We didn't have any evidence to indicate that the product on the market was any safety problem at all,” DeLancey said.
September 14, 2010
The Food and Drug Administration released information Tuesday suggesting it's unimpressed by a weight-loss medication under development by Arena Pharmaceuticals Inc. and casting doubt on the drug's eventual approval. An FDA advisory committee is scheduled to meet Thursday and vote on whether to recommend approval of the drug, lorcaserin. But in documents released Tuesday in advance of the meeting, the FDA noted that studies on lorcaserin showed the average weight loss while taking the drug was not significantly different than the average weight loss among people taking a placebo.
January 7, 2011 |
By late March, tobacco companies will have to reveal to the Food and Drug Administration what sorts of new additives they've recently put in their products. But the ruling doesn't apply to electronic cigarettes, whose makers are locked in legal battle with the FDA. Meanwhile, the e-cigs are starting to gain a pop-culture foothold – in the fall film “The Tourist,” actor Johnny Depp extols the devices’ virtues to Angelina Jolie, and Katherine Heigl showed up recently on the "Late Show with David Letterman" smoking the e-cigarette indoors.
December 27, 2010 |
Remoxy may not have the name recognition of Percocet, but its makers say it has something Percocet and similar drugs don't have -- little potential for addiction. They've asked, again, that the FDA approve Remoxy. Like Percocet, Remoxy contains oxycodone, an opiate that Americans like quite a bit. Unlike other formulations, however, Remoxy employs a special controlled-release formula designed to limit its abuse. The National Institute on Drug Abuse reports that of 7 million Americans abusing prescription drugs in 2009, 5.3 million were abusing pain relievers.
February 12, 2014 |
The U.S. Food and Drug Administration is investigating the illnesses of children in three states in recent months that have been linked to Uncle Ben's infused rice served in schools. The cluster of illnesses have affected children in Texas, Illinois and North Dakota. At three schools in Katy, Texas, 34 students and four teachers experienced skin reactions, burning, headaches and nausea last week after eating Uncle Ben's "Mexican flavor" infused rice. The symptoms lasted about 90 minutes, officials said. Similar reactions were reported at an Illinois school in December and a daycare center in North Dakota in October. Mars Foodservices, which produces the product, has recalled 5- and 25-pound bags of various rice products primarily sold to schools, restaurants, hospitals and other commercial establishments.
June 21, 2011 |
The Food and Drug Administration says it could use an international helping hand in testing the influx of imported drugs and food. Acknowledging the monitoring difficulties inherent in a global economy, the agency said in an announcement Monday that it needs to transform the way it protects the nation's food and drug supply, teaming up with other agencies around the world to ensure quality and safety of the products it regulates. “Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” Commissioner of Food and Drugs Margaret A. Hamburg said in the announcement.
June 14, 2011 |
FDA to Kellogg: One of your facilities is contaminated with listeria. Clean it up. That’s the gist of a warning letter, dated June 7, the Food and Drug Administration sent to Kellogg after a February inspection of a cookie plant found Listeria monocytogenes , the bacteria that causes the food poisoning listeriosis . The Augusta, Ga. plant makes various Keebler and Famous Amos cookies. The agency didn’t find the pathogen in any Kellogg foods, but on and around conveyor belts in the production line.