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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 - 165

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...

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 ...

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...

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...

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...

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."

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:<...

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...

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...

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...

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 ...

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...

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 ...

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...

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.

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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, ...

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...

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...

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...

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...

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...

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 ...

There is no cure for migraines -- a headache disorder that can cause sensory disturbances and nausea -- but several new treatments may help people with the debilitating condition, a neurologist says.

"Ten new treatments for migraines have been approved by the U.S. Food and Drug Administration [FDA] over the past six years," said Dr. Stephen Ross, from Penn State Health Neuroscience In...

The U.S. Food and Drug Administration is enforcing a previously issued ban on sales of sweet-flavored e-cigarette cartridges -- a move to fight the youth vaping epidemic that may have broader consequences.

But it turns out that adults like dessert-flavored e-cigarettes, too, researchers at Penn State College of Medicine found.

"Our data show that flavors aren't just popula...

U.S. officials are cracking down on companies selling fraudulent products that claim to prevent or treat the new coronavirus.

Seven companies -- whose goods range from essential oils to colloidal silver -- were sent warning letters from the U.S. Food and Drug Administration and the U.S. Federal Trade Commission, the FDA said Monday.

"The FDA considers the sale and promotion ...

Asthma and allergy drug montelukast -- sold as a generic and under the brand name Singulair -- will get a "boxed warning" over potential ties to neuropsychiatric effects, the U.S. Food and Drug Administration announced on Wednesday.

The drug has long carried a warning that it has been linked with an increased risk of "agitation, depression, sleeping problems, and suicidal thoughts and...

The first generic version of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis has been approved by the U.S. Food and Drug Administration.

"Today's approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS, by paving the way for more choices in treatment options," FD...

A clinical trial of the weight-loss drug Belviq (lorcaserin) shows an association with an increased risk of cancer, and the U.S. Food and Drug Administration is requesting that its maker withdraw the drug from the U.S. market.

Eisai Inc. has already "submitted a request to voluntarily withdraw the drug," Dr. Janet Woodcock, who directs the FDA's Center for Drug Evaluation and Research...

The newly approved drug teprotumumab can offer hope to adults with thyroid eye disease, a rare and potentially blinding condition.

It's the first treatment specifically approved for thyroid eye disease. The drug was approved Tuesday by the U.S. Food and Drug Administration. It will be marketed under the brand name Tepezza.

"This may be a drug that offers a new approach and ...

The chemicals in sunscreens help shield people from the sun's rays, but they are also absorbed into the body at levels that raise some safety questions, a new study confirms.

The study, by the U.S. Food and Drug Administration (FDA), is a follow-up to a 2019 investigation. Both reached the same conclusion: The active ingredients in popular sunscreens can be absorbed into the blood at ...

It's safe again to buy and eat romaine lettuce grown on farms around Salinas, California, the U.S. Centers for Disease Control and Prevention said Wednesday.

Back in November, the CDC first issued a warning on Nov. 22 that consumers should avoid all romaine lettuce grown in Salinas, Calif., due to possible contamination with E. coli bacteria.

But as of Wednesday, the outbre...

New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.

Researchers report that more than 8 out of 10 new drugs in 2018 benefitted from at least one special program that streamlines the approval process.

The res...

The U.S. Food and Drug Administration is adding to a list of recalled lots of popular heartburn medications -- including generic forms of Zantac -- because the pills might contain small amounts of a suspected carcinogen.

The substance, called N-Nitrosodimethylamine (NDMA), is an environmental contaminant that can be found in water and foods and has been classified as a "probable human...

For decades, consumers have often been puzzled by what a "serving" means on Nutrition Facts labels on foods.

Well, things might have just gotten a bit clearer. New labeling regulations went into effect in January, and on many products you'll now see the total amount of calories (and various nutrients) per serving, as well as for the whole package.

"With the introduction of t...

A lot of the dope you read online about the benefits of marijiuana is just hooey, but it can influence attitudes and actions, researchers say.

Looking at tens of thousands of pot-related posts on Twitter, researchers saw a lot of bogus health claims that they fear may drown out solid science.

"These misleading messages are pervasive online," said researcher Jon-Patrick Alle...

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