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.
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.
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.
June 23, 2011 |
The Food and Drug Administration is essentially telling U.S. consumers worried about silicone breast implants: “Told you so.” But in releasing new research backing up its 2006 decision to allow the implants back onto the market, the agency also reminds women, in a way, that they have only two choices — silicone or saline. So let’s take a look at those options. Until 2006, silicone implants had been under a 14-year ban by the FDA because of concerns that leaks or ruptures could increase the risk of certain diseases, including breast cancer and connective tissue diseases.
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.
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.
March 30, 2011 |
Are food dyes linked to attention deficit hyperactivity disorder in children? The Food and Drug Administration is publicly considering that question for the first time in years. From yellow to purple, artificial dyes have been used for decades to make all kinds of foodstuff more visually palatable, including Cheetos and Lucky Charms. They’re a nearly inescapable feature of any diet rich in packaged, brightly colored foods – but some consumer groups, including the Center for Science in the Public Interest in 2008, have argued that the dyes are responsible for making children hyperactive.