FDA

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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...

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...

Obama Will Allow Morning-After Pill for All Ages

DOJ will drop appeal against unrestricted access to Plan B

(Newser) - The Obama administration has dropped its push for age restrictions for access to the Plan B morning-after pill. The Justice Department had been fighting a judge's decision to allow girls of any age to access the pill without a prescription, but announced it is dropping the appeal, the New ...

Whole Foods Has Big Labeling Mix-Up

Reversed labels on chicken, vegan salads

(Newser) - Whoops. Whole Foods, a chain that likely has no shortage of vegan customers, mixed up the labels on its curried chicken salad and its vegan "chick'n" salad at more than a dozen stores across the Northeast this week, the chain announced today. The snafu affected stores in Connecticut,...

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 OKs Morning-After Pill for Ages 15 and Up

'Plan B' will be available over the counter

(Newser) - The Plan B morning-after pill is moving over the counter. The FDA announced today that the emergency contraceptive will be available without a prescription to those ages 15 and older. The pill also no longer needs to be behind pharmacy counters. Instead, it can sit on drugstore shelves just like...

FDA's New Target: Caffeine Lurking in Your Chips, Gum

Officials fear effects on kids

(Newser) - Gum, jelly beans, trail mix, and potato chips: Added caffeine is popping up everywhere these days, "beyond anything FDA envisioned," says an official, who adds that the FDA only once offered specific consent for added caffeine in a food—for colas in the 1950s. Now, the agency has...

FDA: Clinics May Have Received Fake Botox

No reports of patients getting counterfeit stuff

(Newser) - The FDA is warning of a Botox threat to US customers: Clinics may have ended up with fake material instead of the authentic stuff from Allergan Inc. Officials have found counterfeit Botox in the country, though thus far, there haven't been reports of patients being injected with it. According...

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