Food and Drug Administration

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Eyedrops Recalls Illustrate Holes in FDA Oversight

Agency needs greater authority to ensure safety, experts say

(Newser) - When you buy eyedrops at a US store, you might assume the product was made in a clean, well-maintained factory that's passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little US officials know about the conditions at some manufacturing...

FDA Ties Lead-Tainted Applesauce to Cinnamon

'WaPo' probe finds nearly 120 kids with lead poisoning after consuming applesauce pouches

(Newser) - Back in October, a handful of kids in North Carolina turned up with elevated lead levels in their blood, tied back to the WanaBana brand of applesauce pouches. Now, the Washington Post reveals that nearly 120 children may be victims of such poisoning. The paper reports that, per its own...

This Is Why You Shouldn't Bring a Gun Into an MRI

Patient, 57, ended up shot in the butt after sneaking a firearm into the machine

(Newser) - It might seem obvious to most that one probably shouldn't bring a firearm into a large machine with a powerful magnetic field, but one woman learned that lesson the hard way. The Messenger first reported on the "adverse event" cited by the Food and Drug Administration , in which...

Salmonella Infections Linked to Cantaloupe Kill 3

Authorities warn people not to eat pre-cut cantaloupe if they don't know the source

(Newser) - Consumers shouldn't eat pre-cut cantaloupe if they don't know the source, US health officials said Thursday, as the number of illnesses and recalls tied to a deadly salmonella outbreak grows. At least 117 people in 34 US states have been sickened by contaminated cantaloupe, including 61 who were...

FDA Proposes Banning Controversial Pop Ingredient

California has already banned brominated vegetable oil

(Newser) - The Food and Drug Administration might follow California's lead with a ban on a controversial ingredient found in some citrus-flavored soft drinks. CBS News reports that the agency has proposed banning brominated vegetable oil, which has been used in drinks for around a century. The ingredient, which includes bromine,...

FDA: These Eyedrops Could Blind You
FDA Warns:
These Eyedrops
Could Blind You
IN CASE YOU MISSED IT
Nov 4, 2023 4:10 PM CDT

FDA Warns: These Eyedrops Could Blind You

Affected eyedrops should no longer be used, agency warns

(Newser) - US health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness, the AP reports. The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health, Target, Rite...

It Feels 'Like Being Stabbed All Over.' A New Cure Is Closer

Panel clears CRISPR gene-editing product for sickle cell disease patients; FDA to weigh in

(Newser) - Sickle cell disease is a painful, debilitating, and possibly deadly inherited disorder that currently can only be remedied with a bone marrow transplant. Now, Boston's Vertex Pharmaceuticals hopes exa-cel, its treatment developed with CRISPR Therapeutics, will soon be approved by the FDA following a thumbs-up from a panel of...

If You Had This Fruit Puree Pouch, Get a Blood Test

FDA says some WanaBana products have 'extremely high concentrations of lead'

(Newser) - WanaBana fruit puree pouches might sound like a healthy option for parents to give their kids, but the FDA is warning that anyone who consumed one should get their blood tested for what appears to be "extremely high concentrations of lead." As the New York Times reports, the...

CVS Yanks Completely Ineffective Cold Meds

Move comes after FDA found oral phenylephrine to be a useless decongestant

(Newser) - CVS Health is pulling various cough and cold medicines from its shelves after an FDA advisory panel determined the active ingredient doesn't work. Phenylephrine, approved in the 1930s, has long been found in over-the-counter syrups and pills meant to resolve sinus congestion. However, an FDA analysis found the ingredient,...

FDA Has Big News on Postpartum Depression Front

Sage Therapeutics introduces fast-acting Zurzuvae, the first pill for condition afflicting new moms

(Newser) - Hundreds of thousands of women suffer from postpartum depression annually, and while the serious condition that emerges after childbirth often resolves within weeks, for other women, it can stretch for months, even years, and cause feelings that may even prove dangerous. Now, the Food and Drug Administration has announced a...

Influencer-Backed Energy Drink Has People Worried

Lawmakers want FDA to investigate PRIME

(Newser) - An influencer-backed energy drink that has earned viral popularity among children is facing scrutiny from lawmakers and health experts over its potentially dangerous levels of caffeine, the AP reports. On Sunday, Sen. Charles Schumer called on the Food and Drug Administration to investigate PRIME, a beverage brand founded by the...

Alzheimer's Drug Receives Experts' Support for Approval

Leqembi, which already has conditional OK, costs about as much as Aduhelm

(Newser) - Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer's drug, a key step toward opening insurance coverage to US seniors with early stages of the brain-robbing disease. The drug, Leqembi, received conditional approval from the Food and Drug Administration in January based on early...

FDA Has a New Rule for Gay, Bisexual Blood Donors

Gay, bisexual men in monogamous relationships can now donate without abstaining from sex

(Newser) - Gay and bisexual men in monogamous relationships can give blood in the US without abstaining from sex under updated federal health guidelines that focus on donors' behavior, not their sexual orientation. The Food and Drug Administration guidelines finalized Thursday ease decades-old restrictions designed to protect the blood supply from HIV....

FDA Issues Warning on Amniotic Fluid Eye Drops

Agency says products have not been approved

(Newser) - Amniotic fluid—the fluid that surrounds a fetus in the womb—is among the many things that you shouldn't put in your eyes, the Food and Drug Administration says. In a notification issued earlier this month, the agency said manufacturers are "marketing and distributing amniotic fluid eyedrops" for...

Misinformation Is Hurting Life Expectancy: FDA Chief

Robert Califf says Americans are being misled on more than COVID

(Newser) - Life expectancy is the US has been declining , including in relation to comparable high-income countries, and one federal official says part of the reason is the recent explosion of misinformation. "Why aren’t we using medical products as effectively and efficiently as our peer countries?" Robert Califf, commissioner of...

Abortion Pill's Fate Uncertain as Judges Face Off

Texas' Kacsmaryk orders hold on mifepristone access, Washington's Rice orders the opposite

(Newser) - Access to the most commonly used method of abortion in the US plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years. For now, the drug that the Food and Drug Administration approved in...

FDA Approves OTC Narcan
You Will Be Able
to Buy Narcan OTC
Mar 29, 2023 8:41 AM CDT

You Will Be Able to Buy Narcan OTC

FDA gives the thumbs-up for drug to be sold over the counter

(Newser) - The FDA on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, reports...

Migraine Sufferers May Soon Have Their Very Own 'EpiPen'

FDA approves zavegepant, or Zavzpret, a fast-acting nasal spray designed to provide pain relief

(Newser) - A new nasal spray from Pfizer has just been OKed by the Food and Drug Administration, and the company hopes it will be a game changer for the nearly 40 million migraine sufferers in the US. Reuters reports on the FDA's Friday approval of zavegepant, sold under the brand...

FDA Makes Move Against 'Zombie Dope'

Xylazine, or 'tranq', increasingly found in illicit drug mixes, is subject of new import alert

(Newser) - The FDA is taking action to restrict unlawful imports of xylazine, an animal tranquilizer increasingly used in the illicit drug market , where it's commonly known as "tranq" or "zombie dope" due to its tendency to cause flesh to rot and die. Horror stories accompany the sedative, which...

FDA Wants to Keep Almond, Soy Drinks Called 'Milk'

Dairy producers have pushed for labeling changes

(Newser) - Soy, oat, almond, and other drinks that bill themselves as milk can keep using the name, according to draft federal rules released Wednesday. Food and Drug Administration officials issued guidance that says plant-based beverages don't pretend to be from dairy animals – and that US consumers aren't confused...

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