FDA

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FDA Approves Drug for Penis Curvature

Xiaflex is a little pricey, though

(Newser) - Men suffering from serious and even painful penis curvature have a new medical option—if they can afford to pay $26,000 or more. The FDA has approved Xiaflex , a drug that targets Peyronie's disease by reducing the build-up of a protein that creates scar tissue in the penis,...

FDA Smacks Down Home Genetic Testing Kits

Letter tells 23andMe to stop marketing kit immediately

(Newser) - The FDA has ordered 23andMe to "immediately discontinue marketing" its genetic testing kits, saying that the company has repeatedly failed to prove the product actually works. The Google-backed company offers mail-in genetic testing, which it promises can reveal your risk for various health conditions and drug allergies. In a...

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...

12% of Your Spices May Be Contaminated With 'Filth'

FDA also finds that 7% of imported spices have salmonella

(Newser) - Great, the FDA has identified one more thing for people to worry about in the kitchen: spices. The most comprehensive testing yet finds that 7% of spices imported into the country are contaminated with salmonella, reports the Los Angeles Times . That's twice as high as other foods inspected by...

In First, FDA Wants Safety Standards for Pet Food

Move designed to prevent scares like 2007 China crisis

(Newser) - The FDA today proposed new safety standards for pet food and farm animal feed, which, if passed, would be the first of their kind the agency has ever implemented. The rules cover such basic stuff as sanitation, hazard analysis, and manufacturing practices, NBC reports. "We have been pushing feed...

FDA Wants Tougher Rules for Painkillers Like Vicodin

It recommends tighter restrictions for painkillers with hydrocodone

(Newser) - It will likely be tougher for people to get their hands on Vicodin and similar painkillers next year. The FDA today recommended tougher restrictions for drugs made with hydrocodone, reports Reuters . Assuming the guidelines are approved by the department of Health and Human Services, patients would get fewer refills, and...

FDA: Jerky Treats Still Killing Dogs

Agency asks veterinarians, owners for help in years-long outbreak

(Newser) - The FDA reached out to veterinarians and pet owners today for help in figuring out why nearly 600 dogs have died and another 3,600 have gotten sick since 2007 after eating jerky treats, reports NBC News . Most of the treats have come from China , but the agency hasn't...

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...

Acetaminophen Kills 150 Americans a Year: Report
Acetaminophen Kills 150 Americans a Year: Report
ProPublica
Sep 20, 2013 12:28 PM CDT

Acetaminophen Kills 150 Americans a Year: Report

And the toll doesn't have to be that high, investigative report concludes

(Newser) - The FDA has been dragging its feet when it comes to regulating acetaminophen—the active ingredient in Tylenol and many other drugs—or at least implementing safety precautions, and Americans have been dying as it does so, a new Pro Publica / This American Life investigation concludes. Over the past...

New Way to Get a Caffeine Jolt: Spray It On

Startup trying to sell sprayable version

(Newser) - If you like energy drinks but hate the drinking part, then Harvard undergrad Ben Yu and venture capitalist Deven Soni have a product for you. The two are trying to launch a product called "Sprayable Energy," that, you guessed it, gives you a jolt of caffeine straight through...

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...

Salad May Not Be Only Culprit in Diarrhea Outbreak

The 'epidemiology looks a bit different' says one official

(Newser) - The cyclospora outbreak, believe to be linked to prepackaged salad in Iowa and Nebraska, just got a little ickier: Experts say that salad may not be the sole source of the stomach bug, which causes "sometimes explosive diarrhea"and has now sickened a confirmed 397 people across 16 states...

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...

Hundreds Sick After Eating ... Salad?

Cyclospora outbreak in Iowa and Nebraska traced back to prepackaged salad mix

(Newser) - Hundreds of people in Iowa and Nebraska are suffering from a stomach bug , and health officials think they've found the culprit: lettuce. A prepackaged salad mix has been linked to an outbreak of cyclospora, hitting at least 145 in Iowa and 78 in Nebraska, reports the AP . The salad...

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....

Menthols Might Be Worse Than Regular Cigarettes

Because they make people more likely to smoke: FDA panel

(Newser) - The days of menthol cigarettes might be doomed: A new FDA review suggests that menthols are more dangerous than regular cigarettes, reports Reuters . It's not because they're any more toxic—it's because the mint flavor, along with menthol's ability to mask the harshness of a cigarette,...

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...

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