September 11, 2010
While the outrage over salmonella-tainted eggs was rightly focused on Congress' failure to pass long-overdue food safety legislation and the Food and Drug Administration's refusal to require vaccination of chickens, something equally appalling but less noticed had been going on at the two Iowa egg farms involved. Even though U.S. Department of Agriculture employees worked full time at both filthy facilities, there was no word from them about the rodents, maggots and piles of leaking manure.
December 13, 2011 |
U.S. health regulators sent warning letters to eight California surgical centers and a marketing firm for providing misleading information while advertising Allergan Inc.'s Lap-Band, a device used to treat obesity. The U.S. Food and Drug Administration said billboards and advertising inserts used by the surgical centers and the marketing firm 1-800-GET-THIN fail to provide required risk information, including warnings, precautions and possible side effects. The FDA issued warning letters to Bakersfield Surgery Institute Inc, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons, Valencia Ambulatory Center, Cosmopolitan Plastic & Reconstructive Surgery and San Diego Ambulatory Center.
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.
December 3, 2010 |
Invisible braces sound perfect, especially if you're an adult trying to look and act your age. But the FDA says Invisalign, which makes one type of invisible braces, failed to report information on side-effects in patients. Here's the Associated Press story detailing some patients' complaints about allergic reactions to the devices and the FDA advisory letter . And, of course, the response from Invisalign maker Align Technology Inc. in San Jose. None of this is to say that crooked teeth should stay crooked.
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.
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)
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 31, 2012 |
The first drug that targets an underlying cause of cystic fibrosis rather than the symptoms -- essentially allowing some sufferers to live a nearly normal life -- has been approved by the Food and Drug Administration. The drug Kalydeco (also known by its generic name, ivacaftor) helps a defective protein that acts as a chloride-pump in cell membranes to function properly, restoring the proper flow of water in the body. As a result, patients' mucus-filled lungs begin to clear, making them less prone to infection and perhaps allowing them to live far beyond the age of 37 -- the current average life expectancy.