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.
September 16, 2011 |
An apple a day may keep the doctor away, but apple juice? That's asking for trouble. Witness the white-hot flames of controversy this week over Dr. Mehmet Oz's claims that apple juice contains unhealthful levels of arsenic. Here's the background in a nutshell: On his syndicated television show, Oz made the claims about apple juice containing arsenic, which prompted the Food and Drug Administration and others to fire back, saying that Oz's claims were unfounded and that the juice was safe to drink.
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.
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.
November 22, 2010 |
Medical innovation saves lives, but each drug and device requires careful scrutiny by the Federal Drug Administration before being deemed safe to market. But does the federal agency take too long in its approval process? Dr. Josh Makower says yes. The consulting professor of medicine at Stanford University co-wrote a study of 200 medical technology companies and reports his findings in this column by Nicole Brochu of the South Florida Sun Sentinel . The column reads in part: "For low- and moderate-risk devices, the process to navigate the FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators.
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)
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.
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.