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NEWS
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.
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BUSINESS
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.
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NEWS
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)
OPINION
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.
SCIENCE
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.
SCIENCE
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.
NEWS
April 21, 2011 | By Marissa Cevallos, HealthKey
Hey, hand sanitizers. You can only do so much – and preventing MRSA infection isn’t one of those things -- so stop over-promising! That was the gist of warning letters from the Food and Drug Administration to four makers of the popular products. Apparently, the manufacturers of Staphaseptic, Safe4Hours, Dr. Tichenor’s and CleanWell products had suggested that various gels, protectants and what-not could protect against infection with methicillin-resistant Staphylococcus aureus bacteria.
NEWS
July 8, 2013 | By Jon Healey
In a recent post , I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.
NEWS
April 13, 2012 | By Alexandra Le Tellier
The U.S. Food and Drug Administration's proposal for voluntary guidelines that would wean livestock off  growth-inducing antibiotics left foodies and public health officials disappointed this week. “Nonbinding recommendations are not a strong enough antidote to the problem,” argued Rep. Louis Slaughter (D-N.Y.). Avinash Kar, public health staff attorney for the Natural Resources Defense Council, replied to the news with a statement equivalent to an eye roll: “We've essentially had a voluntary measure in place for 35 years since FDA first acknowledged the risks of using antibiotics in livestock feed, and we have seen the use of antibiotics grow exponentially in that period.” Food Politics' Marion Nestle was also frustrated: “I'm guessing this is the best the FDA can do in an election year,” she lamented , saying the proposal looked more like a “direct challenge to drug companies and meat producers to clean up their acts” than a real solution.
NEWS
April 23, 2011 | By Marissa Cevallos, HealthKey
The FDA is asking companies that make painkillers to create educational materials, written in simple language, on how to safely use and throw away opiates as part of the government’s new effort to curtail prescription drug abuse.  Opiate-drug makers will also have to propose a plan in 120 days on how they will train doctors to manage pain and screen patients, the FDA announced Tuesday.    Certain drugs the companies sell are being...
NEWS
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.
SCIENCE
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.
NATIONAL
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.
SCIENCE
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.
SCIENCE
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.
BUSINESS
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.
BUSINESS
April 25, 2011 | By Stuart Pfeifer, Los Angeles Times
Here is a roundup of alleged cons, frauds and schemes to watch out for. Prescription drug calls — The Food and Drug Administration is cautioning consumers about an extortion scam that involves criminals who pose as FDA agents. The criminals call victims and tell them they are under investigation by the FDA or another law enforcement agency for illegally buying prescription drugs from foreign pharmacies, the agency said. The callers tell victims that they'll face prosecution unless they pay a fine over the phone with a credit card, the FDA said.
OPINION
June 5, 2011
The U.S. Food and Drug Administration barely had time to start regulating cigarettes before legislation was introduced to weaken its authority. The Family Smoking Prevention and Tobacco Control Act was passed in 2009 with sweeping majorities in both houses; its primary goal was to reduce the terrible toll that smoking takes on Americans' health, especially by discouraging young people from taking up the habit. The law gave the FDA the authority to regulate the advertising and packaging of cigarettes, along with ingredients such as nicotine and flavorings that affect how easily the public is drawn into smoking and how addictive the habit is once started.
BUSINESS
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.
OPINION
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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