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03 Aug

Tracking Vaccine Safety After FDA Approval

Researchers say vaccines are remarkably safe due to rigorous monitoring

Health News Results - 137

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

MONDAY, Feb. 22, 2021 (HealthDay News) -- 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 th...

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 duri...

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...

What to Know About Pulse Oximeters

If you use an oxygen concentrator and a pulse oximeter at home, proper use is crucial, the U.S. Food and Drug Administration says.

Conditions such as asthma, lung cancer, chronic obstructive pulmonary disease, the flu and COVID-19 can all cause oxygen levels in the body to drop. When levels are too low, oxygen therapy may be required to boost them.

One way to get extra oxygen i...

Newer Rheumatoid Arthritis Drug May Help Ease Tough-to-Treat Cases

A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinical trial reports.

Arthritis sufferers treated with upadacitinib had a significantly greater reduction in their symptoms and disease activity than people treated with a standard disease-modifying antirheumatic drug (DMARD), said co-resea...

Bogus 'Cure' Claims Have U.S. Consumers Snapping Up CBD Products

CBD has been widely marketed as a cure-all for whatever ails you, and a new study finds many Americans are buying the sales pitch.

Researchers tracking a Reddit forum on CBD found many folks discussing use of cannabidiol to treat conditions for which there are proven, safe and effective medicines and therapies.

Forum participants said they were using CBD for mental and emotional...

Animal Study Points to Heating Coil Behind Serious Vaping Injuries

The type of heating coil used in an e-cigarette and the amount of voltage sent through it could be contributing to vaping-related lung injuries, a new animal study contends.

Laboratory rats suffered lung injuries when exposed to vapor from devices using high-powered heating coils made of nickel-chromium alloy, something that did not occur in earlier experiments using stainless steel h...

4 in 10 Teens, Young Adults Have Used CBD Oil, Study Finds

Many teenagers and young adults may be using so-called CBD products, often in the belief that they will aid health conditions, a preliminary study suggests.

Researchers found that of 200 U.S. teens and young adults who landed in their emergency room, 40% said they had used CBD oil. Some did it "just for fun," but others thought CBD "can help to treat my medical illness."

Was FDA Lax in Approving Opioids Too Easily?

For at least two decades, the U.S. Food and Drug Administration has been approving new formulations of prescription opioids without requiring drug manufacturers to gather important information on safety and effectiveness, a new study claims.

The FDA approved dozens of these highly addictive medications for treatment of chronic pain between 1997 and 2018 based on clinical trials that:<...

Hazardous Ingredients Make 'Smart Drug' Supplements a Not-So-Smart Buy

Maybe you're a senior concerned that your mind has started to lag a bit. Or maybe you're a college student looking for an edge in your classes.

Either way, a new study warns that you should seriously reconsider taking any over-the-counter supplement that promises a powerful brain boost.

A review of so-called "smart drug" nutritional supplements found a handful that were pack...

FDA Adds Abuse Warning to Labels for Xanax, Valium

Reacting to an upsurge in abuse of benzodiazepine sedatives such as Valium, Xanax and Ativan, U.S. officials on Wednesday added a "Boxed Warning" to the drugs' labels, cautioning about the danger.

Benzodiazepines are tranquilizers commonly prescribed to help ease issues such as anxiety, seizures, insomnia and panic disorders.

But "while benzodiazepines are important therapie...

Quick and Cheap, New COVID-19 Test Could Enhance U.S. Screening Efforts

The new rapid COVID-19 test approved last week is probably not the most reliable option for determining whether someone is infected.

But it's cheap and it's fast, and if used correctly, it could be the basis of a screening strategy to keep Americans safe as they return to school and work, infectious disease experts say.

The BinaxNOW COVID-19 Ag Card produced by Abbott Labora...

Artificial Pancreas Controls Diabetes in Kids 6 and Up, Clinical Trial Shows

An artificial pancreas system is safe and effective at managing blood sugar levels in kids as young as age 6 with type 1 diabetes, according to a new study.

The system uses a continuous glucose monitor (CGM) to track blood sugar levels and automatically delivers insulin when needed using an insulin pump. It replaces reliance on fingerstick or CGM with delivery of insulin by injection ...

Animal Tests Point to Possible Path to Ultrafast Insulin

An experimental ultrafast-acting insulin could work four times quicker than current fast-acting formulas, researchers say.

For the study, the researchers focused on a form of insulin called monomeric insulin. Though its structure should, in theory, allow it to act faster, monomeric insulin is too unstable for practical use, so the Stanford University team had to find a way around that...

FBI: Beware of Scammers Selling Fake COVID-19 Antibody Tests

Fake or unapproved COVID-19 antibody tests are being sold by scammers, the Federal Bureau of Investigation warns.

The FBI said fraudsters are also trying to get people's personal information (such as names, birthdates and Social Security numbers) as well as personal health information (including Medicare and/or private health insurance info). This information can be used in insurance ...

Ad Displays in Stores Boost Teen Vaping Rates: Canadian Study

Canadian provinces that allow retail displays promoting e-cigarettes had nearly three times the teen vaping rate, a new study found.

Until May 2018, e-cigarettes weren't widely available in Canada and it was illegal to advertise those containing nicotine. When the law changed, Quebec and Manitoba adopted their own restrictions, including bans on retail displays and ads for e-cigarett...

FDA Approves 'Prescription Video Game' for Kids With ADHD

The first video game to help treat kids with attention-deficit/hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.

EndeavorRx is a prescription-only game designed to help improve attention in 8- to 12-year-olds with ADHD who have confirmed attention problems.

It is the first game-based treatment authorized by the FDA for any condition.

FDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19

The U.S. Food and Drug Administration has withdrawn its emergency authorization for the use of two malaria drugs championed by President Donald Trump in the fight against COVID-19.

The agency said in a letter Monday that the drugs, hydroxychloroquine and chloroquine, are "unlikely to be effective" as treatments for the coronavirus, The New York Times reported.

The FD...

FDA Approves First Antigen Test to Quickly Spot Coronavirus Infection

The first emergency use authorization for a COVID-19 antigen test has been issued by the U.S. Food and Drug Administration.

Antigen tests are a new category of tests for use in the coronavirus pandemic and quickly detect fragments of proteins from the virus in samples collected by swab from people's noses.

The approval was issued Friday to the Quidel Corp. for the Sofia SA...

FDA Approves First At-Home Saliva Test for COVID-19

The first COVID-19 test using saliva samples that patients collect at home has been approved by the U.S. Food and Drug Administration.

The emergency use authorization was issued to Rutgers Clinical Genomics Laboratory for the diagnostic test using home-collected samples. Patients return their sample to the New Jersey-based lab in a sealed package for analysis.

The screening...

FDA Goes After Unproven COVID-19 Antibody Tests

The U.S. Food and Drug Administration said Monday it will crack down on the fraudulent COVID-19 antibody tests that have flooded the market.

Companies selling coronavirus antibody tests will be required to submit data proving accuracy within the next 10 days, or their products could be yanked from public circulation, FDA officials said.

Since mid-March, dozens of manufacture...

FDA Bans Products That Help Kids Hide Vape Use From Parents

With more American teens taking up e-cigarettes, there's a flood of products designed to allow them to vape without getting caught by parents or teachers -- and federal officials want to put a stop to it.

On Monday, the U.S. Food and Drug Administration announced it was sending warning letters to 10 manufacturers to stop making these products targeting youth.

"The public sh...

As Demand for Hand Sanitizer Soars, FDA Warns of Makers' Bogus Claims

Some companies are selling hand sanitizers with unproven claims that they'll protect you from the new coronavirus, the U.S. Food and Drug Administration warns.

Last week, the agency issued its first warning letter for a hand sanitizer marketed with unproven COVID-19-related claims that violated federal law.

The letter was issued to Prefense LLC for making misleading statemen...

FDA Warns Against COVID-19 Treatment With Drugs Touted by Trump

Malaria drugs touted by President Donald Trump as potential "game changers" against COVID-19 are actually too dangerous for general use, the U.S. Food and Drug Administration warned Americans on Friday.

According to the FDA, studies have shown that the drugs chloroquine and hydroxychloroquine may trigger potentially fatal heart rhythm problems in COVID-19 patients.

The agenc...

Juul's Sales Grew Even After Dropping Flavored E-Cigarettes

Weeks after e-cigarette giant Juul voluntarily stopped selling many flavored vaping products popular with U.S. teens, sales rebounded as customers switched to varieties still on the shelves.

In fact, sales eventually surpassed previous records, according to new American Cancer Society (ACS) research.

"When companies are able to make these decisions for themselves, they are...

New COVID-19 Test Could Give Results in Under 1 Hour

Researchers say they've developed a low-cost swab test that can diagnose COVID-19 infections in about 45 minutes.

The CRISPR-based test -- which uses gene-targeting technology and requires no specialized equipment -- could help relieve testing backlogs in the United States as COVID-19 continues to spread, the scientists said.

The U.S. Food and Drug Administration has not app...

FDA Tackles Questions About Blood Donation, Face Masks During Pandemic

It is safe to donate blood during the coronavirus pandemic? Do cloth face masks offer meaningful protection against COVID-19?

These are among the questions Americans are asking, according to the U.S. Food and Drug Administration, and the agency is offering some answers.

A number of measures are being taken to protect the nation's blood supply, according to the FDA. Blood do...

Don't Believe the Hype: Bogus Products, Coronavirus Scams Abound

Can zinc help shorten a COVID-19 infection? Will vitamin C or other supplements prevent it?

These claims and plenty more can be found on social media and internet sites, but be advised: There is no pill or treatment that can prevent or cure COVID right now.

"We want to think that there is a quick way to get rid of this. But there is not a product out there that will keep y...

FDA Warns of Dangerous, Bogus Claims That Bleach Can Treat COVID-19

A warning letter has been sent to a company marketing bogus and dangerous chlorine dioxide products for the prevention and treatment of COVID-19, the U.S. Food and Drug Administration says.

The fraudulent claims by the Genesis II Church of Health and Healing about its "Miracle Mineral Solution" products are especially concerning in relation to children, who are at increased risk for h...

How One Patient's Battle With COVID-19 Changed U.S. Testing Protocols

The first community-acquired case of COVID-19 in the United States posed many questions for doctors, but the answers they found led to key changes in federal guidelines for coronavirus testing, according to a case study.

The patient was an otherwise healthy woman in her 40s who was admitted to University of California (UC) Davis Health with a respiratory infection. Doctors suspected c...

Amid COVID-19 Crisis, Blood Donor Restrictions Eased for Gays

America is in urgent need of blood donations during the coronavirus pandemic, so the U.S. Food and Drug Administration said Thursday it will relax donor restrictions placed on gay and bisexual men and others.

Specifically, the FDA has changed the abstinence period required for gay and bisexual blood donors from 12 months to 3 months.

"We know that reducing the deferral peri...

Don't Worry About U.S. Food Supply, FDA Says

The United States remains a land of plenty even in the era of coronavirus, U.S. federal health officials said Thursday.

State-by-state lockdowns may have created a rush on certain items in grocery stores -- toilet paper, dry yeast, flour, rice, dried beans -- but the food supply chains remain strong and shelves should soon be restocked, according to Frank Yiannas, deputy commissioner...

FDA Pulls Heartburn Drug Zantac From Market

All versions of the heartburn drug Zantac (ranitidine) have been pulled from the U.S. market due to possible contamination with a probable cancer-causing chemical, the U.S. Food and Drug Administration said Wednesday.

This is the latest step in an ongoing investigation of N-Nitrosodimethylamine (NDMA) in ranitidine medications, the agency noted.

In some ranitidine products, ...

FDA Approves Malaria Drugs to Treat COVID-19, Despite Little Proof They Work

With little evidence that the malaria drugs hydroxychloroquine and chloroquine can prevent or treat COVID-19, the U.S. Food and Drug Administration has given emergency approval to distribute millions of doses of the medicines to hospitals across the country.

"These drugs will be distributed from the Strategic National Stockpile to states for doctors to prescribe to adolescent and adul...

FDA Warns of Defective EpiPen Dangers

Certain types of EpiPens and their generic counterparts may fail or delay injection of lifesaving epinephrine for severe allergic reactions, the U.S. Food and Drug Administration warns.

Problems may occur in EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors and authorized generic versions due to device malfunctions and user errors, according to the agency.

The devices may...

Many Drugs Already Approved by FDA May Have Promise Against COVID-19

Two new studies each suggest that dozens of drugs already approved for use in the United States may prove effective against the new coronavirus.

"Repurposing these FDA-approved drugs could be a fast way to get treatment to patients who otherwise have no option," explained the co-author of one of the studies, Dr. Hesham Sadek. He's professor in the departments of internal medicine, mol...

FDA Warns Americans to Beware of Fake COVID-19 Test Kits

Fake in-home test kits for coronavirus are being marketed in the United States and could pose serious health risks, the U.S. Food and Drug Administration says.

"We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," said FDA Commissioner Dr. Stephen Hahn and Associate Commis...

New, Graphic Health Warnings Coming for U.S. Cigarette Packs

Graphic new health warnings must appear on cigarette packages and in cigarette ads beginning next year, the U.S. Food and Drug Administration (FDA) says.

As of June 18, 2021, the 11 new warnings must be displayed prominently, filling the top half of cigarette packages on both front and back and at least 20% of the area at the top of ads.

The warnings include text and pho...

How to Understand New Food Labels

Understanding the updated Nutrition Facts Label can help you get the most from it, according to the Academy of Nutrition and Dietetics.

The U.S. Food and Drug Administration announced the update in 2016. The new labels must appear on all food items by Jan. 1, 2021. Many companies already use the updated label, which is based on the latest information about links between nutrition and ...

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