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)
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.
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)
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.
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.
March 19, 2011 |
They used to call it "Edison's medicine" or, with a touch of gallows humor, a "Georgia Power cocktail" ? the practice of hooking mentally troubled patients up to an electrical current and jolting them until they went into convulsions. Pioneered in the late 1930s, electroshock therapy, as it was more commonly known, was a scientifically crude practice that often left patients dazed and disoriented, sometimes with broken bones. For many it became a symbol of the callousness that often characterized the treatment of the mentally ill. But that was then.
January 11, 2012 |
The U.S. temporarily halted shipments of imported orange juice from all countries and said it would destroy or ban products containing even low levels of a banned fungicide. The imports will be held while they're tested and may be sold if levels are below trace amounts, the Food and Drug Administration said Wednesday. The fungicide, linked in studies to a higher risk of liver tumors in animals, was found in trace amounts last month in products from Brazil, which produces almost 1 in 6 glasses of orange juice consumed in the U.S., according to CitrusBR, an export industry association.
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.
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.