FDA

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Even a Little Non-Aspirin Painkiller Could Be Bad News

Risk of heart attack, stroke from NSAIDs higher than thought, even in small amounts

(Newser) - The FDA advised back in 2005 that non-aspirin nonsteroidal anti-inflammatory drugs, or NSAIDs , could up the risk of heart attack and stroke. But the agency is now boosting that warning, noting that drugs like ibuprofen (often sold under the Motrin IB brand), naproxen (Aleve), and celecoxib (Celebrex) may pose a... More »

FDA OKs Pricey New Cystic Fibrosis Drug

It'll cost patients about $250K a year

(Newser) - Federal health officials have approved a new combination drug for the most common form of cystic fibrosis. But it will come at a steep price—more than $250,000 for a year's treatment. The FDA cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that... More »

FDA: Dump 'Heart Attack' Trans Fats in 3 Years

Obama gives food companies 3 years to phase out artificial trans fats

(Newser) - The Obama administration is cracking down on artificial trans fats, calling them a threat to public health. The FDA said today it will require food companies to phase out the use of artificial trans fats almost entirely. Consumers aren't likely to notice much of a difference, but the administration... More »

2 New Cholesterol Drugs May Be Game-Changers

FDA advisory panel recommends both after 2 days of hearings

(Newser) - A new batch of cholesterol-lowering drugs could bring new hope to patients who can't take popular statins, or for those who don't feel their effects. Today, an FDA advisory committee recommended approval of Amgen's Repatha, reports AP , just one day after it gave the green light to... More »

FDA: Dark Chocolate Often Not What It Seems

Unless you like milk in your dark chocolate

(Newser) - Like snacking on dark chocolate? Then we hope you're not doing it to avoid milk, because the US Food and Drug Administration tested 94 dark-chocolate bars and found milk in 61% of them, Quartz reports—including not just products with descriptions like "may contain milk" or "may... More »

Critics: Glaring Problem With FDA's Blood Donation Plan

Those in relationships could still be unable to donate

(Newser) - In December, the FDA revealed it would be ending a lifetime ban on gay men who seek to donate blood, and today, the agency has released its proposal . The FDA will unveil its final guidance after 60 days of public comment, the Huffington Post reports. While gay rights advocates say... More »

FDA OKs Shot to Zap Your Double Chin

Kybella injections said to be noninvasive, can be performed in 5 minutes

(Newser) - About 70% of participants in a 2014 survey by the American Society for Dermatologic Surgery about cosmetic procedures pointed fingers at chin and neck fat as a "top concern," per the Washington Post . But a drug just approved by the FDA looks to banish double chins, ABC News... More »

FDA to KIND: Your 'Healthy' Bars Aren't Really Healthy

FDA finds issues with how 4 bars are labeled

(Newser) - File under the "learn something new every day" category: The FDA regulates the use of a "+" in food labeling—and says KIND has been using it improperly on two of its snack bars. Bloomberg reports the FDA has taken issue with four KIND bars (list here ),... More »

Addicts Find Ways Around 'Abuse-Deterrent' OxyContin

People find new ways to dissolve the pills—or turn to heroin, study says

(Newser) - When an "abuse-deterrent" version of OxyContin was introduced in 2010, the intent was clear: "to make OxyContin more difficult to solubilize or crush, thus discouraging abuse through injection and inhalation," the New England Journal of Medicine noted in 2012. Made with special binders, the revamped pills would... More »

17 Patients Sick After Getting 'Simulated' IV Fluids

FDA opens inquiry over saline mistake

(Newser) - One patient died and 17 others got sick after at least 40 patients were given unsterilized intravenous fluids instead of the sterile saline solution they should have received. Officials aren't sure the unsterilized solution caused the death, which was of a hospice patient, the FDA notes. The fluids that... More »

FDA Lifting Lifetime Ban on Gay Men Donating Blood

But there will still be restrictions

(Newser) - The FDA announced today that it will lift its lifetime ban on blood donations from gay and bisexual men, the Los Angeles Times reports. Instead, men who have had sex with men will be allowed to donate blood one year after last having sexual contact with another man, the FDA... More »

FDA's New Calorie Rules Are a Bit of a Shock

They're more far-reaching than expected

(Newser) - Whether you're headed to Chili's or the movies, you'll soon be seeing a lot more calorie counts posted. The FDA is today announcing what a nutrition expert calls "one of the most important public health nutrition policies ever to be passed nationally," the New York ... More »

Shocking Students May Not Be OK With FDA

Massachusetts school alone in using controversial practice

(Newser) - On second thought, the FDA isn't so sure that painful electric shocks are a good way to keep unruly autistic people in line. For years the Judge Rotenberg Educational Center, a Massachusetts school for people with intellectual disabilities, has been outfitting students prone to aggressive behavior or self harm... More »

Ebola Drug Given to Aid Workers Was Made by...

... a company in San Diego called Mapp Biopharmaceutical

(Newser) - Two American aid workers infected with Ebola are getting an experimental drug so novel it has never been tested for safety in humans and was only identified as a potential treatment earlier this year, thanks to a longstanding research program by the US government and the military. The workers, Nancy... More »

Surgeon General: Quit Tanning Now

Country's top doctor says skin cancer is 'major public health problem'

(Newser) - Your doctor, your mom, and your shade-obsessed friends have probably all told you already about the dangers of suntanning—and now the surgeon general is jumping on the anti-bronzing bandwagon for the first time. Boris Lushniak today called skin cancer a “major public health problem,” and pointed a... More »

Combo Painkiller Designed to Be Tougher to Abuse

FDA approves opioid that won't cause euphoria when crushed

(Newser) - The FDA has approved a new form of OxyContin that unites two unlikely bedfellows in an attempt to curb abuse, reports AP . The drug from Purdue Pharma is called Targiniq ER, and it combines oxycodone—the main painkilling ingredient in OxyContin, one that causes feelings of euphoria—with naloxene, which... More »

US Might Finally Improve Your Sunscreen

Congress pushing bill that would speed up FDA backlog on ingredients

(Newser) - The US is way behind other countries when it comes to sunscreen, thanks to a backlog at the FDA, reports Time . For more than a decade, key ingredients used all over the world have been held up in the US waiting for government approval. Even 2002 legislation aimed at speeding... More »

Illegal Smallpox Turns Up in Maryland Lab

It may have been there since the 1950s

(Newser) - Smallpox is a terrifying pathogen that by international agreement can be studied only at two labs in the world, one in the US and one in Russia. So it's just a wee bit disconcerting that another lab in Maryland just realized it's had some lying around, apparently for... More »

FDA: Acne Meds Can Cause Life-Threatening Reactions

Warning issued for over-the-counter products

(Newser) - In rare cases, common over-the-counter acne products can cause severe and sometimes life-threatening allergic reactions, the FDA warns. Reactions include shortness of breath, fainting, and collapse, and almost half of those who reported severe symptoms required hospitalization, reports USA Today . The agency says it has had only 131 cases of... More »

FDA's Murky Ruling Could Be Stinky News for Cheese

FDA decision could mean trouble for 65% of cheesemakers

(Newser) - Bad news, cheese lovers: The delicious snack's future is uncertain after a recent FDA decision. The FDA clarified last week that wooden racks, used by many cheesemakers to age their product, "cannot be adequately cleaned and sanitized." That means cheesemakers who have been using such racks for... More »

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