Food and Drug Administration

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Painkiller 'Will Kill People as Soon as It's Released'

Some 40 experts hope FDA will reevaluate potentially-deadly Zohydro

(Newser) - A new FDA-approved painkiller isn't set to hit pharmacy shelves until next month, but critics are already warning it could kill—with just two pills. Zohydro, which the FDA gave the green light in October against the advice of its advisory panel, will serve as a powerful pain pill...

Big Changes Coming to Food Labels

FDA proposing calories per package and adjusted serving size

(Newser) - You may no longer have to squint at nutrition labels to see the calories you're consuming. For the first time in more than 20 years, the FDA is proposing big changes to packaged food and drink labels, requiring calories and more realistic portion sizes to be in large, bold...

FDA Cracks Down on &#39;Dangerous&#39; Acetaminophen
 FDA Cracks Down 
 on 'Dangerous' 
 Acetaminophen 
in case you missed it
Jan 18, 2014 7:01 PM CST

FDA Cracks Down on 'Dangerous' Acetaminophen

Agency wants prescription combo drugs to contain no more than 325mg per dose

(Newser) - The FDA is taking steps to more closely regulate acetaminophen, issuing an official warning that doses over 325mg may hurt your liver. The FDA is asking doctors to stop prescribing "combination" drugs that contain more than that amount per dose—pain medications including Percocet, Vicodin, and codeine often contain...

Princeton Students to Get Vaccine FDA Hasn't OKed

Bexsero hasn't been approved by FDA, but FDA gave CDC OK to import it

(Newser) - Princeton University has seen seven people hospitalized in the last eight months with bacterial meningitis—specifically, a strain of the disease that the vaccine commonly administered in the US doesn't fight. And now the school is taking the unusual step of offering its students a European- and Australian-approved vaccine,...

90 Tons of Salad Recalled
 90 Tons of Salad Recalled 
Nov 11, 2013 9:19 AM CST

90 Tons of Salad Recalled

Trader Joe's affected after 26 people sickened with E. coli

(Newser) - More than 90 tons of ready-to-eat salads and sandwiches by a California catering company are being recalled after 26 people in three states were sickened by a bacterial strain of E. coli linked to its products, federal health officials said yesterday. Glass Onion Catering is recalling approximately 181,620 pounds...

US to Ban Trans Fats
 US to Ban Trans Fats 
Nov 7, 2013 11:52 AM CST

US to Ban Trans Fats

FDA takes first step

(Newser) - The US Food and Drug Administration is announcing today that it will require the food industry to gradually phase out trans fats, saying they are a threat to people's health. The agency is not yet setting a timeline for the phase-out, but it will collect comments for two months...

Johnson & Johnson Will Pay $2.2B Over Kickbacks

It's the third-largest US settlement involving a drugmaker

(Newser) - Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil allegations of promoting three prescription drugs for off-label uses not approved by the Food and Drug Administration, the Department of Justice announced today. The allegations include paying kickbacks to physicians...

Big Pharma Paid for Seat at FDA Advisory Table

Gave up to $25K per meeting on painkiller safety

(Newser) - Drug companies shelled out in a big way to get a seat at meetings between the FDA and an advisory panel, paying up to $25,000 per meeting, the Washington Post reports based on hundreds of emails. The panel, which was funded by the money, helped the FDA evaluate painkiller...

Sleep Drugs Under Gun for Doing Job Too Well

FDA is cracking down on drowsy drugs that affect drivers

(Newser) - Back in January , the FDA told drugmakers to reduce their recommended dosage for sleep aids in an effort to stop people from zonking out on their morning drive to work. Now it's cracking the whip. The agency says it will push manufacturers for more extensive driving tests, write...

FDA: Tylenol Can Cause Rare Skin Diseases

Still, it's not recommending consumers switch to another pain reliever

(Newser) - The FDA is warning consumers that acetaminophen—the active ingredient in Tylenol—can cause rare skin diseases characterized by rashes, blisters, and, very occasionally, extreme damage to the skin's surface. The agency hastened to add that it wasn't advising that everyone abandon acetaminophen in favor of another pain...

Mysterious Stomach Bug Hits 7 States, 275 People

CDC, FDA investigating cyclospora infections

(Newser) - Federal health authorities say more than 275 people in seven states have now been sickened with an unidentified stomach bug. The Food and Drug Administration is investigating the cyclospora infections, which are often found in tropical or subtropical countries and have been linked to imported fresh produce in the past....

FDA Cracks Down on Arsenic in Apple Juice

Must meet standards for drinking water

(Newser) - Warnings of low levels of arsenic in apple juice have parents worried, but the FDA is taking action. Though the agency has insisted the amounts found in the juice aren't hazardous, it will now require that arsenic levels in apple juice be no higher than those allowed in drinking...

Growing Threat to Medical Gadgets: Malware

FDA calls on manufacturers to devise security plans

(Newser) - What happens when malware attacks the very devices keeping us healthy? The threat has the FDA concerned, the Wall Street Journal reports: "We are aware of hundreds of medical devices that have been infected by malware," says a senior official. Thus far, there haven't been any known...

Wrigley Yanks Caffeinated Gum

It will wait on 'Alert' until FDA finishes regulations

(Newser) - Sorry, caffeine junkies, but you'll have to keep getting your energy boosts the old-fashioned way, because Wrigley is putting its Alert caffeinated gum on hold. The FDA raised concerns about caffeine increasingly popping up in weird things like gum and jelly beans, and a Wrigley exec says in a...

Germ Killer We've Used for 40 Years Gets FDA Review

Researchers to complete review of triclosan ordered back in the '70s

(Newser) - It's been on the market for more than 40 years, and it's found in everything from antibacterial soap to toothpaste to toys. But there's a chance that the FDA is about to declare the chemical triclosan unsafe, in a review due to be completed this year. The...

FDA Blocks Generic OxyContin
  FDA Blocks Generic OxyContin 
Apr 17, 2013 4:01 AM CDT

FDA Blocks Generic OxyContin

Move prevents crushable form returning to market

(Newser) - In a big victory for campaigners against prescription drug abuse—as well as for OxyContin maker Purdue Pharma—the FDA has blocked generic drugmakers from making their own versions of the powerful painkiller. The ruling came on the day that Purdue's patent on the old, crushable, and widely abused...

FDA OKs Morning Sickness Drug It Pulled 30 Years Ago

Pill now considered safe

(Newser) - A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm. Yesterday's FDA decision means...

FDA Abandons Gruesome Cigarette Warnings

Feds won't challenge free speech ruling

(Newser) - Big Tobacco can breathe easier: The Food and Drug Administration has scrapped a series of graphic warning labels for cigarettes after deciding not to challenge a court ruling that said the shocking images violated free-speech protections, the Wall Street Journal reports. The labels included images such as diseased lungs and...

FDA Tweak Could Be Boon for Alzheimer's Drugs

Proposal could make it easier to get early-stage drugs OKed

(Newser) - Good news in the Alzheimer's arena: The FDA could ease the rules for approving new drugs to treat the disease, reports the New York Times . Under the proposed plan, the FDA would be able to OK drugs that returned improved results on memory or reasoning tests in clinical trials...

Sugar, Not Obesity, Is Our 'Smoking Gun'

Study conclusively finds that sugar is toxic, declares Mark Bittman

(Newser) - Sugar is "toxic," and is hands-down the biggest problem with the American diet, declares Mark Bittman in the New York Times . He cites a new study that finds increased sugar consumption is linked to increased diabetes rates, regardless of obesity rates. "In other words, according to this...

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