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)
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."
CALIFORNIA | LOCAL
May 10, 2013 |
Federal regulators said Friday that they would continue to allow sales of generic Opana, a narcotic painkiller similar to OxyContin, even though the pills are prone to abuse. Like OxyContin, Opana is an extended-release narcotic designed to offer pain relief over several hours. When extended-release pills can be crushed, they are popular among addicts who snort the powder or liquefy and inject it, releasing the full dose at once. In response to growing criticism of its widely abused OxyContin, Purdue Pharma introduced a tamper-resistant formulation in 2010.
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...
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?
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.
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 8, 2013 |
Responding to the Food and Drug Administration's move to banish trans fats from the nation's diet, some public health advocates grumped Thursday that the agency was playing catch-up to a trend already well underway nationwide. Still, many of the same experts expressed hope that the FDA's move will open the way to a new era in the agency's regulation of food additives. By setting several new precedents, the FDA's decision on trans fats may bring some of our most beloved ingredients -- salt and sugar -- under new scrutiny by the agency, they predicted.
January 7, 2011 |
By late March, tobacco companies will have to reveal to the Food and Drug Administration what sorts of new additives they've recently put in their products. But the ruling doesn't apply to electronic cigarettes, whose makers are locked in legal battle with the FDA. Meanwhile, the e-cigs are starting to gain a pop-culture foothold – in the fall film “The Tourist,” actor Johnny Depp extols the devices’ virtues to Angelina Jolie, and Katherine Heigl showed up recently on the "Late Show with David Letterman" smoking the e-cigarette indoors.
December 18, 2004 |
WASHINGTON - The Food and Drug Administration on Friday warned physicians to consider alternatives to the popular arthritis drug Celebrex because of new evidence that, like the similar drug Vioxx, removed from the market in September, it doubles the chances of heart attacks and strokes. The federal agency said it may soon take other actions, including requiring stronger warnings, or even blocking the drug from sale. The statements call into question the future of the widely used class of painkilling drug called Cox-2 inhibitors.