March 2, 2011 |
The Food and Drug Administration plans to remove some unapproved prescription cough, cold and allergy medicines now sitting on store shelves, the agency announced Wednesday. The products, which may be inappropriately labeled for use by infants and young children, could pose an unnecessary risk because they haven't been tested for safety and efficacy, the FDA said. Some may have risky ingredients, and others -- marketed as 'timed release' -- may release active ingredients too slowly, too quickly or inconsistently.
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.
October 24, 2013 |
The Food and Drug Administration has laid out a roadmap for greater strictures on the prescribing and dispensing of hydrocodone and analgesics that contain it. The move is the latest in a chain of actions taken by the FDA and other agencies to address a burgeoning U.S. crisis of addiction to opioid painkillers. Under a plan announced by the FDA on Thursday afternoon, products containing the opioid painkiller hydrocodone, including combination analgesics such as Vicodin (which mixes hydrocodone with acetaminophen)
April 9, 2013 |
The Food and Drug Administration on Monday approved a drug to treat the severe nausea and vomiting that some women experience during early pregnancy. The Canadian-made medication will be marketed as Diclegis. It is the only prescription medication approved for pregnant women experiencing "morning sickness" that does not go away with a bland diet of small meals that are low in fat. Diclegis was once known and marketed in the United States as Bendectin and taken by as many as one in 10 pregnant women.
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.
March 21, 2013 |
La Preferida Inc. is voluntarily recalling 56,808 29-ounce cans of La Preferida Whole Pinto Beans, the U.S. Food and Drug Administration announced Thursday. "The manufacturer's preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed," the FDA said. "To date, there have been no reported injuries or adverse events associated with the consumption of this product.
June 18, 2013 |
The Food and Drug Administration says it is investigating the unexplained deaths of two patients in the wake of receiving intramuscular injections of the antipsychotic medication Zyprexa (generic name olanzapine). The patients died three to four days after receiving appropriate doses of Zyprexa Relprevv, which is designed to release slowly into the blood over two to four weeks and provide regular dosing for adults with schizophrenia. The FDA says the deaths occurred well after the three-to-four-hour window following injection during which patients should be monitored in a physician's office for a potentially deadly complication called post-injection delirium sedation syndrome (PDSS)
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.
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.