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July 8, 2010 | By Thomas H. Maugh II, Los Angeles Times
The Food and Drug Administration on Thursday cautioned consumers against using quinine for leg cramps, warning that the drug could cause severe side effects, including death. Quinine, sold in this country under the brand name Qualaquin, is approved for treatment of uncomplicated malaria, but has a long history of use as a remedy for leg cramps, especially at night. In many countries, it is sold over the counter. Studies have shown that it can reduce the incidence of cramps by one-third to one-half but that as many as one in every 25 users can suffer serious side effects.
April 25, 2014 | By Shan Li and Lalita Clozel
A new federal proposal to regulate electronic cigarettes has Patrick Sanchez pondering the future of the fledgling industry. Sanchez is the owner of Vapegoat, a Highland Park e-cigarette shop that doubles as an art gallery. On a normal night, customers kick back on his comfy couches, surrounded by brick walls hung with Salvador Dali-esque paintings, and try out new e-cig flavors. Since opening in September, Sanchez said, business has boomed as more smokers discovered the battery-operated devices, which heat liquids that usually contain nicotine to create a vapor that can be inhaled.
June 29, 2009 | Melissa Healy
For most of the last 15 years, the Food and Drug Administration's authority to regulate tobacco has been either a thwarted promise or a fitful threat, depending on your point of view. It has been pressed by anti-smoking crusaders and public health groups, put on hold by the Supreme Court and beaten back repeatedly by the tobacco industry and its political allies.
April 24, 2014 | Times Editorial Board
It has taken far too long for the U.S. Food and Drug Administration to impose regulations on e-cigarettes: More than three years have passed since it announced its intention to do so. During that time, the devices have caught on with teenagers, whose use of them doubled from 2011 to 2012. And the rules proposed Thursday will not be finalized for at least another year. The new regulations are appropriately strong in many ways, banning sales to minors and requiring the disclosure of ingredients as well as evidence for any marketing claims that e-cigarettes are healthier than traditional cigarettes.
May 31, 2012 | By Tiffany Hsu
The Food and Drug Administration rejected a petition from the Corn Refiners Assn. to rename high-fructose corn syrup “corn sugar,” saying that the change could confuse consumers and “pose a public health concern.” In a letter to association President Audrae Erickson made public Wednesday evening, the federal agency told the industry group that using “corn sugar” on nutrition labels could even prove dangerous for customers who...
March 11, 2014 | By Monte Morin
The U.S. Food and Drug Administration has approved the marketing of an electronic medical device intended to treat migraine headaches. In an announcement released Tuesday, officials said the transcutaneous electrical nerve stimulation, or TENS, device was the first ever to receive such approval. The device, which will be marketed under the name Cefaly , is manufactured by Cefaly Technology of Belgium. "Cefaly provides an alternative to medication for migraine prevention," read a prepared statement from Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health.
February 16, 2014 | By Steven Woloshin and Lisa M. Schwartz
Could you have low testosterone? That's the question Abbott Laboratories (now AbbVie) has been urging men to consider with its "Is It Low T?" awareness campaign, a highly effective effort to change how doctors and the public think about managing aging in men. Since 2008, this massive marketing endeavor has targeted middle-aged men who have put on some weight, sometimes feel grumpy or get sleepy after meals, encouraging them to have their testosterone...
June 28, 2013 | By Melissa Healy
Is it hot in here, or am I just depressed? For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery of hot flashes, as well. No surprise, then, that a pharmaceutical company came up with the idea to market an antidepressant for treatment of vasomotor symptoms, a.k.a. hot flashes. And on Friday, bucking the recommendation of its advisory committee on reproductive health drugs, the Food & Drug Administration approved the idea.
October 27, 2010 | By Andy Zajac, Los Angeles Times
It’s no secret that the public health regulatory apparatus is stretched thin in many places, perhaps no component more so than the woefully understaffed food inspection side of the Food and Drug Administration. But say this for the FDA food police: When they do get around to looking a place over, they pay loving attention to detail. Acting on a court order sought by the FDA, U.S. marshals today seized an estimated $700,000 worth of adulterated rice and other food packaged in (unfortunately)
October 31, 2013 | By Monte Morin
The U.S. Food and Drug Administration announced Thursday that it was stepping up efforts to prevent and address prescription drug shortages, calling the shortfalls a significant public health threat. In addition to expanding early reporting requirements for drug manufacturers, the FDA said it was launching a smartphone app that would give consumers instant information on pharmaceutical shortages. "The complex issues of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
April 24, 2014 | By Lalita Clozel
WASHINGTON - The Food and Drug Administration's move to regulate e-cigarettes drew criticism Thursday from some public health advocates, who said the regulations do not go far enough to protect young consumers. The proposed rule would for the first time allow the government to limit the manufacture and sale of e-cigarettes, as well as cigars and pipe tobacco. Sales to minors would be banned and health warning labels required. But the new rules would not ban online sales or restrict youth-friendly flavors such as watermelon and peppermint.
April 23, 2014 | By Melissa Healy
The Food & Drug Administration is warning that injections of corticosteroids into the spine's epidural space -- an extremely common treatment for radiating back or neck pain -- in rare cases may result in loss of vision, stroke, paralysis and death. And that's even in the absence of fungal and other contamination introduced by compounding pharmacies that killed 48 people in 2012 and 2013. Physicians offering these injections to patients with back or neck pain should discuss these rare but serious risks with patients considering a jab of steroidal medication into the cerebrospinal fluid, the FDA said Wednesday.
April 23, 2014 | By Lalita Clozel
WASHINGTON - The Food and Drug Administration plans to begin regulating electronic cigarettes for the first time, banning sales to minors and requiring manufacturers to put health warnings on the nicotine-delivering devices that have become a multibillion-dollar industry, according to officials who described the agency's proposal. But the agency will stop short of steps that many public health advocates and some members of Congress have called for, including restrictions on television advertisements and flavorings, such as pumpkin spice or chocolate, that may target younger consumers, officials said.
April 3, 2014 | By Melissa Healy and Lisa Girion
Federal officials said Thursday they hoped a new "rescue pen" would help reduce the death toll from overdoses involving prescription painkillers. The Food and Drug Administration approved the sale, by prescription, of the prefilled auto-injector of the drug naloxone that caregivers or family members can use to reverse the effects of prescription painkillers, such as OxyContin and Vicodin, and heroin. Available until now only by syringe, naloxone has been a workhorse drug in emergency departments battling the relentless rise in painkiller overdoses over the last decade.
April 3, 2014 | By Melissa Healy
Opioid drug overdoses, the cause of some 16,000 fatalities and  half a million emergency-department visits yearly, may have met their match: The Food and  Drug Administration on Thursday approved the sale, by prescription, of a hand-held auto-injector of the opioid-reversal drug naloxone, a "rescue pen" that caregivers or family members can use to avert a potentially fatal overdose. Delivered by syringe, naloxone has been a workhorse drug in emergency departments battling the relentless rise of opioid abuse in the last decade.
April 2, 2014 | By Stuart Pfeifer
MannKind Corp. shares were up nearly 80% Wednesday after the Valencia company said an FDA advisory panel had backed its inhaled diabetes drug that could replace most insulin injections. The panel voted 13-1 to recommend that the FDA approve the drug, Afrezza, for the treatment of Type 1 diabetes and 14-0 to approve it for the more common Type 2 diabetes. The FDA doesn't have to follow the panel's recommendation, but the panel's nod was considered a key hurdle for the company.
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?
April 17, 2013 | By Melissa Healy
Three years after it approved a version of the opioid analgesic OxyContin designed to discourage the painkiller's abuse, the Food and Drug Administration has effectively barred the original form of the drug from ever reaching the legal U.S. market. The agency says it will approve no new applications from generic drug manufacturers to produce cheaper versions of OxyContin in its original form. OxyContin has been one of the nation's most abused prescription painkillers, in part because as those addicted to the potent drug built up tolerance for it, they could easily ground it up or dissolve it in water, making the potent extended-release drug easy to snort or inject for a faster, more intense high.
April 1, 2014 | By Stuart Pfeifer
Shares of Intuitive Surgical Inc. jumped more than 12% Tuesday after the Sunnyvale company said the Food and Drug Administration had approved the latest version of its robotic surgical system. The company said in a statement that its new Da Vinci Xi system has longer, thinner arms that provide greater range of motion and can be used in more types of procedures than earlier models. "Our goal is to develop technology that enhances surgical performance," said Gary Guthart, Intuitive's president and chief executive.
March 14, 2014
Re "The labels on generic drugs," Editorial, March 12 The Times objects to a Food and Drug Administration proposal to allow generic drug manufacturers to update safety labeling to warn of newly discovered risks, as brand-name manufacturers have long been permitted to do. The editorial is based on the misperception that the law requires branded and generic labeling to be identical. In fact, FDA regulations allow generic labeling to "include differences in expiration date, formulation, bioavailability, or pharmacokinetics," among other things.
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