Food and Drug Administration

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Nut Products Recalled Over E. Coli, Listeria Risk

Walnuts linked to E. coli outbreak, Planters products linked to listeria risk

(Newser) - At least a dozen people in California and Washington have been sickened with E. coli food poisoning linked to organic walnuts sold in bulk in 19 states, US health officials said Tuesday. The nuts were sold in natural food and co-op stores such as Whole Foods and Market of Choice,...

FDA Delays Approval of Eli Lilly's Alzheimer's Drug
FDA Stalls on New
Alzheimer's Drug

FDA Stalls on New Alzheimer's Drug

'We were not expecting this,' says Eli Lilly president

(Newser) - Eli Lilly's experimental Alzheimer's drug is facing yet another delay on the path toward FDA approval. The company's donanemab medication was first expected to be cleared last year and later by the end of this month. However, the drugmaker announced Friday that approval isn't expected until...

Lab Wants Recall of Common Acne Meds

They may contain elevated levels of a cancer-causing chemical

(Newser) - An independent lab is calling on the FDA to suspend sales of benzoyl peroxide after finding the acne medication degraded into a cancer-causing chemical in products from popular brands like ProActiv and Clearasil. Valisure analyzed 99 acne treatment products containing benzoyl peroxide (BPO). Before heating, the carcinogen benzene was detected...

First Drug for Severe Food Allergies Is Approved

FDA says Xolair can help people with allergies to milk, eggs, nuts, other sources

(Newser) - A medication used to treat asthma can now be used to help people with food allergies avoid severe reactions, says the FDA. Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reactions caused by accidental exposure to food triggers, per the AP . Patients...

Biogen Abandons Aduhelm After Problem-Filled Launch
Maker Gives Up
on Alzheimer's Drug

Maker Gives Up on Alzheimer's Drug

Approval process, pricing, and murky benefits contributed to Aduhelm's failure on the market

(Newser) - Biogen announced Wednesday that it is stopping its clinical trials of an Alzheimer's drug, will no longer sell it, and is forsaking the ownership rights. Along with federal regulators, the company had faced major criticism over the development and pricing—at $56,000 per year—of Aduhelm. Biogen said...

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

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...

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