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Results for search "Food &, Drug Administration".

03 Aug

Tracking Vaccine Safety After FDA Approval

Researchers say vaccines are remarkably safe due to rigorous monitoring

Health News Results - 173

Doctors Divided Over Use of Controversial New Alzheimer's Drug

The controversial new Alzheimer's drug Aduhelm is creating something of a civil war in medicine, as health networks, hospitals, insurers and individual doctors weigh impending discussions with patients about whether they should take the medication.

Many doctors believe the U.S. Food and Drug Administration "moved the goalposts" to approve Aduhelm (aducanumab) in early June, and they aren'...

Biden Says Full Approval for COVID Vaccines Coming Soon

As he urged Americans who are still hesitant to get vaccinated, President Joe Biden told an Ohio town hall on Wednesday night that he expected the U.S. Food and Drug Administration would soon give final approval to COVID-19 vaccines.

At the moment, all three vaccines being used in this country have only emergency use approval. But many medical professionals have pushed for the final ...

Muffins Recalled for Possible Listeria Contamination

Possible listeria contamination has triggered the nationwide recall of more than two dozen muffin products made by Give and Go Prepared Foods, the U.S. Food and Drug Administration said Wednesday.

The recalled products were sold across the country and include a variety of Uncle Wally's twin muffins, The Worthy Crumb large muffins, Stop n Shop mini muffins, 7-Eleven Selects muffins, Freshn...

FDA to Prioritize Full Approval for Pfizer COVID Vaccine

Pfizer Inc. announced on Friday that the U.S. Food and Drug Administration has granted priority review to its COVID-19 vaccine, positioning the vaccine for full approval by January.

The Pfizer vaccine has been administered to more Americans than any other shot so far in the U.S. vaccination campaign. According to data from the U.S. Centers for Disease Control and Prevention, some 85 milli...

FDA Approves First Lymphoma Drug for Dogs

The first full approval of a drug to treat lymphoma in dogs has been granted by the U.S. Food and Drug Administration.

"While canine lymphoma affects fewer than 70,000 dogs in the U.S. annually, it accounts for up to 24% of all cancers in dogs, making it one of the most significant canine cancers," Steven Solomon, director of the FDA's Center for Veterinary Medicine, said in an agency new...

Two Major Health Systems Won't Administer Controversial New Alzheimer's Drug

Two major U.S. health systems say they will not administer the controversial new Alzheimer's drug Aduhelm.

The decisions by the Cleveland Clinic and Mount Sinai's Health System in New York City are the latest fallout from the U.S. Food and Drug Administration's widely criticized approval of the Biogen drug on June 7, The New York Times reported.

Many experts say there's no ...

Five Neutrogena and Aveeno Spray Sunscreens Recalled Due to Benzene

Five Neutrogena and Aveeno spray sunscreen products have been recalled because they may contain small amounts of benzene, Johnson & Johnson announced Wednesday.

Benzene is a human carcinogen and can get into the body through the skin, through the mouth and by inhalation, the company said in a statement.

"Out of an abundance of caution, we are recalling all lots of these specific aer...

New Prescribing Instructions Tighten Use of Controversial Alzheimer's Drug

The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer's medication Aduhelm that will likely limit its use.

When first approved a month ago, the FDA said Biogen's monthly IV drug was for all Alzheimer's patients. The agency now says the drug is appropriate for patients with early or mild Alzheimer's but that it has not been studied i...

House Committees to Investigate New Alzheimer's Drug Approval

THURSDAY, July 1, 2021 (Healthday News) -- The U.S. Food and Drug Administration's controversial approval of a new Alzheimer's drug, along with its high price, is now being investigated by two House committees.

"We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefi...

How to Safely Use the Right Flea and Tick Product for Your Pet

When choosing and using flea and tick products for your pets, there are a number of things to consider, the U.S. Food and Drug Administration says.

Work with your veterinarian to select the right product for your pet's species, life stage and weight.

These products range from pills and chews given by mouth to collars, sprays, dips, shampoos, powders, and "spot-ons," liquid products ...

Hand Sanitizer Vapors Can Cause Nausea, Dizziness

The coronavirus pandemic has had an unexpected side effect -- a wave of bad reactions to alcohol-based hand sanitizers.

Vapors from the products can cause headache, nausea and dizziness, according to the U.S. Food and Drug Administration, which advises consumers to use the products in well-ventilated areas.

"We have received increasing reports of these side effects since the start ...

COVID Antibody Treatment Is Safe, Effective in Transplant Patients

Antibody treatments are safe and effective for transplant patients with mild to moderate COVID-19, a new study shows.

Monoclonal antibodies help prevent the SARS-CoV-2 virus from attaching to cells, which helps block the spread of infection.

The findings are important, researchers said, because transplant patients with COVID are more likely to be severely ill or die.

"Monoclon...

FDA Defends Approval of Controversial Alzheimer's Drug

The U.S. Food and Drug Administration has approved the first new drug to treat Alzheimer's disease in nearly two decades, in a controversial decision that left the agency defending its reputation and its science.

Aduhelm (aducanumab) treats Alzheimer's by clearing out amyloid beta, a sticky protein known to form plaques in the brains of early-stage patients.

It is the first approved...

'Historic' Decision Expected on U.S. Approval of Alzheimer's Drug

The first drug ever shown to slow the progression of Alzheimer's disease could be approved by the U.S. Food and Drug Administration on Monday, but experts say that approval will be surrounded by controversy.

In clinical trials, aducanumab showed a 22% reduction in the development of thinking and memory problems associated with Alzheimer's disease, according to a statement from the Alzheim...

Many Existing Drugs Could Be Potent COVID Fighters: Study

It has been an elusive goal so far -- finding a potent treatment that can beat back the new coronavirus before it grabs a hold of a patient's immune system and sends it into overdrive.

But new research suggests that more than a dozen existing drugs or drugs under development may do the trick.

Investigators tested more than 12,000 drugs in two different types of human cells infected ...

NIH Starts Trial Assessing 'Mix & Match' COVID Vaccine Approach

Moderna plus Pfizer? J&J plus Moderna? There's a new clinical trial underway to assess the safety and effectiveness of mixing different types of booster shots in adults who have been fully vaccinated against COVID-19.

"Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of ne...

FDA Warns of Bogus Fertility Claims for Some Supplements

Women who are struggling to get pregnant, beware of false dietary supplements that claim to help cure infertility and other reproductive health issues.

Such supplements are not approved by the U.S. Food and Drug Administration and they could prevent patients from seeking effective, approved drugs, the agency warned.

"These purported fertility aids seek to profit off of the vulnerabi...

FDA Approves Third COVID Antibody Treatment for Emergency Use

A third antibody treatment designed to keep high-risk COVID-19 patients from winding up in the hospital was approved for emergency use by the U.S. Food and Drug Administration on Wednesday.

Importantly, in lab tests the newly authorized drug, dubbed sotrovimab, neutralized the highly infectious virus variant that is crippling India, as well as variants first spotted in Britain, South...

There's Been a Shift in Who's Funding Alzheimer's Research

The U.S. government and nonprofits are replacing drug companies as the main drivers of Alzheimer's disease research, two new studies show.

The findings are from an analysis of national data by Jeffrey Cummings, a research professor at the University of Nevada, Las Vegas School of Integrated Health Sciences.

In one study, his team found that the number of Alzheimer's clinical trials ...

Magnets in Cellphones, Smartwatches Might Affect Pacemakers, FDA Warns

The U.S. Food and Drug Administration is warning that strong magnets in some cellphones and smartwatches can interfere with pacemakers and other implanted medical devices.

Studies have shown that these high-strength magnets may cause some implants to switch to "magnet mode," stopping normal functioning until the magnet is moved away from the device.

Many implants have a "magnet mode...

Reviews Find No Evidence Weight-Loss Supplements Work

You're getting no real benefit from taking weight-loss supplements like garcinia cambogia, green tea extract, glucomannan, conjugated linoleic acid or chitosan, two new reviews show.

Most of the clinical trials studied didn't show these supplements producing any weight loss among users, the researchers said. In the rare cases where people did lose weight, they didn't drop enough pounds to...

Many Consumers Misunderstand Those 'Best Before' Food Labels

People may think they know what 'Best before' food date labels mean, but a new study reveals that many consumers misunderstand them.

The study of over 2,600 U.S. adults "showed that an overwhelming majority of consumers say that they use food date labels to make decisions about food and say they know what the labels mean," said study author Catherine Turvey,. She's from the department of ...

FDA Poised to Ban Menthol Cigarettes

The U.S. Food and Drug Administration on Thursday proposed a ban on menthol cigarettes, a move that the agency has tried before and one that public health experts and civil rights groups have pushed for years.

Menthol cigarettes have been marketed aggressively to Black Americans for decades: About 85% of Black smokers use menthol brands, the FDA said, and research shows menthol cigarettes...

Race Against Time: Stricken With ALS, She's Seeking Access to Experimental Drug

Like many proud moms, Lisa Stockman-Mauriello of Summit, N.J., is looking forward to exciting milestones in lives of her three sons over the coming months: One will graduate college, one will enter college, and the third will begin high school.

But unlike other moms, it's not guaranteed that she'll be there to experience them.

Lisa, 51, has amyotrophic lateral sclerosis (ALS), a di...

Know the Signs of Rare Blood Clot Linked With J & J Vaccine

While U.S. federal government experts probe potential risks of the Johnson & Johnson vaccine, what do you need to know if you have had the one-dose COVID shot or hope to get it?

Experts at the American Heart Association (AHA) describe what to look out for.

The U.S. Centers for Disease Control and Prevention and the U.S. Food & Drug Administration paused administration of the J&J (Ja...

J&J Vaccine 'Pause' Is Not Mandate Against the Shot, FDA Says

Extremely rare but life-threatening blood clots linked to the Johnson & Johnson COVID-19 vaccine appear similar to those caused by the AstraZeneca vaccine approved for use in Europe and Canada, U.S. health officials said Tuesday.

Federal officials called for a "pause" in use of the one-dose J&J vaccine while they review data linked to six women between 18 and 48 years of age who developed...

CBD or THC? Cannabis Product Labels Often Mislead, Study Finds

Patients, beware: You might not be able to trust the label on that medical marijuana product you just brought home.

Levels of the two active ingredients in medicinal cannabis -- THC and CBD -- can vary widely from those claimed by distributors, a new study warns.

"People are buying products they think are THC-free but, in fact, contain a significant amount of THC," said researcher J...

FDA Approves First AI Tool to Boost Colonoscopy Accuracy

TUESDAY, April 13, 2021 (HealthDay News) --The first device that uses artificial intelligence (AI) to help detect possible signs of colon cancer during colonoscopy has been approved by the U.S. Food and Drug Administration.

The GI Genius uses AI-based machine learning to help identify lesions such as polyps or suspected tumors in real time during a colonoscopy, according to the agency.

Two Vaccines Show Effectiveness Against Emerging COVID Variants

Two COVID-19 vaccines appear to work well against a rapidly spreading coronavirus variant that arose in California, but less effective against a variant that first emerged in South Africa, researchers report.

"The good news is the California variant does not appear to be a problem for our current vaccines," said study author David Montefiori, director of the Laboratory for AIDS Vaccine Re...

Canada's Menthol Cigarette Ban Boosted Quit Rates: Would the Same Happen in U.S.?

Could banning menthol cigarettes be key to lowering smoking rates overall?

New research suggests it's possible, after finding that a ban on menthol cigarettes in Canada was linked to a large increase in the number of smokers who quit.

The impact of the menthol ban in Canada suggests that a similar ban in the United States would have even greater benefits since menthol cigarettes are...

FDA Approves First New Children's ADHD Drug in 10 Years

The first new drug developed in over a decade for children with attention deficit hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.

Qelbree, also known as viloxazine, comes in a capsule that is taken daily, and is not a stimulant. This makes it harder to abuse than older ADHD drugs, nearly all of which contain the stimulants amphetamine or methylphe...

FDA Clamping Down on Abuse of an OTC  Decongestant

Makers of inhalers that contain the nasal decongestant propylhexedrine should make design changes to prevent misuse, the U.S. Food and Drug Administration says.

Propylhexedrine is a nasal decongestant in over-the-counter inhalers, and right now is "only marketed under the brand name Benzedrex," the FDA said. The agency said that propylhexedrine is effective and safe when used for short pe...

Could a New Drug Help Ease Alzheimer's?

About 7 out of 10 Alzheimer's patients wound up free of the brain plaques that are a hallmark of the disease after treatment with a potentially breakthrough experimental drug, clinical trial results show.

The drug, donanemab, also significantly slowed the patients' brain decline, according to findings published March 13 in the New England Journal of Medicine.

Donanemab diss...

Don't Use Veterinary Drug Ivermectin Against COVID, FDA Warns

Desperate for a treatment against COVID-19, some Americans have reached for an anti-parasitic drug aimed at animals, with serious consequences, the U.S. Food and Drug Administration warns.

"Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans," the FDA cautioned in a statement.

The agency has re...

Formaldehyde in Hair Straighteners Prompts FDA Warning

You might decide your frizzy locks aren't so bad after all, given a new warning from the U.S. Food and Drug Administration that most hair straightening/smoothing products release formaldehyde gas, a human carcinogen.

Being exposed to formaldehyde for longer periods of time and at higher concentrations increases the health risks, according to the FDA.

Formaldehyde exposure can ...

What You Need to Know About the New J&J COVID Vaccine

The U.S. Food and Drug Administration has approved the emergency use of Johnson & Johnson's single-shot coronavirus vaccine, adding a third weapon to the arsenal the United States is building to battle the pandemic.

The overall effectiveness of the J&J vaccine in protecting recipients against any case of COVID-19 (66%) is not as high as that of the Pfizer and Moderna vaccines (95%). But ...

New Variants Mean COVID Vaccines, Tests May Need Tweaking: FDA

The emergence of new SARS-CoV-2 variants could require a quick pivot on the part of pharmaceutical and medical device companies, to help stay one step ahead of COVID-19.

The U.S. Food and Drug Administration issued guidelines Monday encouraging drug and test developers to pay attention to new coronavirus variants and be prepared to make that pivot if necessary.

The guidance provides...

Used to Gauge COVID Severity, Pulse Oximeters Can Be Inaccurate on Darker Skin

Pulse oximeters -- small devices that clip onto fingertips -- can seem like a handy way to gauge oxygen levels while monitoring a case of COVID-19. But people of color should be cautious about relying on them because they're more likely to give inaccurate readings when used on darker skin, the U.S. Food and Drug Administration announced Friday.

The warning was based on a study published ...

New Drug Combo Could Be Advance Against Uterine Fibroids

A new combo pill can substantially reduce bleeding caused by uterine fibroids -- possibly offering some women yet another alternative to surgery, a new trial finds.

The once-daily medication, which combines a drug called relugolix with estrogen and progestin, is not yet approved in the United States. But it is under review by the U.S. Food and Drug Administration, according to drugmaker M...

FDA Approves 'Tongue Strengthening' Device for Certain Sleep Apnea Patients

The U.S. Food and Drug Administration on Friday approved the marketing of a new "tongue strengthening" device to cut down on snoring in patients with mild obstructive sleep apnea.

Unlike devices used during sleep, this prescription device is used while awake, and is designed to stimulate and strengthen the tongue so that it doesn't collapse backward and obstruct the breathing airway durin...

FDA Approves First Once-a-Month HIV Therapy

The first monthly shots to treat adults with HIV were approved by the U.S. Food and Drug Administration on Thursday.

"Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen," said Dr. John...

Pet Food Recall Expands After 70 Dogs Die From Mold Toxin

There's an expanded nationwide recall of Sportmix pet food products underway, after links were found between a mold-borne toxin in the food and the deaths of 70 dogs, with 80 other dogs being sickened, the U.S. Food and Drug Administration announced Monday.

The announcement expands upon a recall first issued on Dec. 30 by Midwestern Pet Foods, Inc. At the time, the company said that at le...

Certain Antibiotics Linked With Upped Risk for Deadly Aortic Aneurysms

A widely used class of antibiotics has been linked to an increased risk of a potentially fatal blood vessel condition -- even in younger, healthy people.

In a study of millions of antibiotic prescriptions made in the United States, researchers found that one class was associated with a small increase in the risk of aortic aneurysm.

The drugs -- called fluoroquinolones -- have been a...

FDA OKs First Over-the-Counter Home Test for COVID-19

The first non-prescription COVID-19 test that enables people to collect samples and get results at home has received emergency use authorization from the U.S. Food and Drug Administration.

"This is a great step forward," said Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, in Baltimore. "If people could know their status on any given day, they could chang...

If You Already Had COVID, Do You Need the COVID Vaccine?

More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators.

Short answer: Yes.

"They will be asked to stand in line and get a vaccine also," said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University...

FDA Advisory Panel Says Yes to Pfizer's COVID Vaccine

A U.S. Food and Drug Administration advisory panel recommended on Thursday that the agency approve the emergency use of Pfizer's coronavirus vaccine, clearing the way for a national campaign to inoculate enough Americans to stop the spread of COVID-19.

The decision came not a moment too soon, as the country reported a record-breaking 3,000 new COVID-19 deaths on Wednesday. The panel vote ...

FDA Panel to Vote on Pfizer's COVID Vaccine

A U.S. Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer's coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday.

That record-breaking statistic is unlikely to drop significantly anytime soon: The number of people hospitalized with COVID...

Youth Vaping Rates Have Plunged During Lockdown: Study

Vaping among teens and young adults has decreased dramatically during the COVID-19 pandemic, with two-thirds of e-cigarette users reporting that they've either cut back or quit, a new study says.

About 32% of e-cigarette users said they quit this year and another 35% reported cutting back, according to survey results published Dec. 3 in JAMA Network Online.

Concerns about l...

Some Talc Products Contain Asbestos: Study

Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos.

Environmental Working Group (EWG) -- an American advocacy nonprofit that commissioned the tests and did the analysis -- said methods used by the cosmetics industry to screen talc supplies are inadequate. The voluntary testing method developed by industry is not sensitive enough to screen for asbestos...

One-Third of E-Cigarette Users Report Signs of Lung Damage: Study

One of every three people who vape say they have symptoms associated with damage to the lungs or respiratory tract, a new study reports.

Specifically, 33% of e-cigarette users reported having one or more of the five symptoms associated with EVALI, or e-cigarette- or vaping-associated lung injury, researchers said.

These symptoms include cough, shortness of breath, nausea, stomach pa...

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