August 24, 2010
If you've bought or used a portable foot-tanning device sold as the "Tootsie Tanner," you should know you have already been fleeced and should probably have your head examined. But to that helpful warning from your Booster Shots team, the FDA on Tuesday added the following: flaws in the Tootsie Tanner and the instructions that accompany it could cause you to burn your feet and damage your eyes. Who knew that foot tanning was in such demand that someone would actually invent and market such a device?
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.
CALIFORNIA | LOCAL
September 19, 1997
Re your Sept. 8 editorial on the threats to the Food and Drug Administration: Not only is the legislation and the president's proposal to cut the funding for the FDA a threat to our nation's health, but also the idea of having private firms that manufacture medical devices assess their safety. I live in a retirement community where many people's quality of life depends on the use of wheelchairs, walkers and electrical vehicles. The malfunction or poor quality of these devices can have serious results to those who depend on them.
April 25, 2011 |
The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up. In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said...
CALIFORNIA | LOCAL
December 27, 2000
David Willman's report on FDA policies (Dec. 20) correctly analyzes the many difficult issues and conflicting pressures the agency faces in regulating the approval of new drugs. Missing from this analysis, however, is the not inconsiderable pressure the agency has had from Congress to let down the barriers and to speed up the approval process. Following the 1994 conservative revolution, Dick Armey, Tom DeLay, Newt Gingrich and their ilk harassed David Kessler and other FDA administrators to desist from "impeding progress."
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.
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.
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.
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.