Results for search "Food &, Drug Administration".
Health News Results - 158
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 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.
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.
- Dennis Thompson
- January 14, 2020
- Full Page
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...
- Steven Reinberg
- January 2, 2020
- Full Page
The first Ebola vaccine approved by the U.S. Food and Drug Administration is a single-dose injection called Ervebo.
The vaccine from Merck & Co. is approved to protect against the Zaire ebolavirus in people 18 and older.
In the United States, Ebola infections are rare. Confirmed cases have involved people in other countries who became infected and then traveled to...
- Robert Preidt
- December 20, 2019
- Full Page
Federal health officials have unveiled plans to allow prescription drug imports from Canada and other foreign nations.
The U.S. Food and Drug Administration is proposing a rule under which states could import some prescription drugs from Canada, U.S. Health and Human Services Secretary Alex Azar announced Tuesday.
The agency also plans to make it easier for drug manufacturer...
- Dennis Thompson
- December 18, 2019
- Full Page
The U.S. Food and Drug Administration on Tuesday approved the sale of two reduced nicotine cigarettes.
Moonlight and Moonlight Menthol cigarettes were given the green light because they contain much less nicotine than traditional cigarettes and they could help adult smokers kick the habit, the FDA said.
"Today's authorization represents the first product to successfully dem...
- Robert Preidt
- December 17, 2019
- Full Page
A drug used to fight chronic myeloid leukemia might also relieve symptoms of Parkinson's disease, a new study finds.
In a phase 2 clinical trial, researchers found that the drug nilotinib (brand name: Tasigna) increased production of dopamine and halted decline in motor function. It was well-tolerated by most participants.
"We found that nilotinib is reasonably safe using d...
- Steven Reinberg
- December 16, 2019
- Full Page
Levels of possible cancer-causing chemicals in metformin diabetes medications are under investigation by the U.S. Food and Drug Administration.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.
Over the past year and a half, several types of drugs -- including angiotensin II receptor blockers (ARBs) used for high blood pressu...
The first generic versions of the multiple sclerosis drug Gilenya have been approved by the U.S. Food and Drug Administration.
The three generic versions of Gilenya (fingolimod) capsules were approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
"Approving safe and effective generics so patients have more treatment options continues to be a prio...
Levels of the widely used chemical bisphenol A (BPA) in people's bodies are much higher than once thought, according to scientists who say they've created a more accurate way to measure them.
BPA is used in many plastic products, including food and drink containers, and animal studies have shown that it can interfere with hormones. Exposure to BPA in the womb has been linked to growth...
It's still not 100% safe to enjoy caesar salads: Federal health officials say more Americans have been sickened with E. coli after eating romaine lettuce thought to be grown in Salinas, Calif.
Case numbers have jumped from 67 reported a week ago to 102 on Wednesday, according to a news release issued by the U.S. Centers for Disease Control and Prevention. Twenty-three states have ...
Ultrasound may provide lasting relief from the involuntary muscle movements that are so debilitating to people with Parkinson's disease and another condition called "essential tremor," a small study concludes.
The treatment is still scarce, but it appears to deliver significant and lasting tremor relief, Italian researchers report.
It's called "focused ultrasound." Though ch...
More Americans have been sickened with E. coli after eating romaine lettuce thought to be grown in Salinas, Calif., federal health officials said Tuesday.
Twenty-seven new cases have been reported over the past few days, according to the U.S. Centers for Disease Control and Prevention. That brings the total to 67 across 19 states.
In 39 cases, illnesses have been so severe a...
The U.S. Food and Drug Administration late Friday issued a warning to consumers to avoid all romaine lettuce grown in Salinas, Calif., due to possible contamination with E. coli bacteria.
The new caution comes after investigation into an outbreak of E. coli illnesses first announced by the U.S. Department of Agriculture (USDA) on Thursday. Forty cases have now been recorded in the ou...
The popular herbal supplement kratom may cause liver damage, researchers warn.
Kratom is widely available in smoke shops and online. It's a botanical product made from Mitragyna speciosa, a tropical evergreen tree found in Southeast Asia. At low doses, it's a stimulant. At high doses, it has an opioid-like effect.
Use of kratom has risen sharply since the start of...
- Steven Reinberg
- November 8, 2019
- Full Page
A three-drug combo that significantly improves lung function in cystic fibrosis patients could benefit 90% of people with the life-threatening disease, a new study suggests.
It included patients with a single copy of the most common genetic mutation for the disease.
Results of the international phase 3 clinical trial led the U.S. Food and Drug Administration to approve ...
Computer-driven artificial intelligence (AI) can help protect human brains from the damage wrought by stroke, a new report suggests.
A computer program trained to look for bleeding in the brain outperformed two of four certified radiologists, finding abnormalities in brain scans quickly and efficiently, the researchers reported.
"This AI can evaluate the whole head in one se...
- Dennis Thompson
- October 24, 2019
- Full Page
Before receiving breast implants, women should be told of the possible risks, the U.S. Food and Drug Administration says in a draft proposal.
The agency suggests a boxed warning and a checklist outlining potential harms, such as pain, fatigue and further surgery.
"We have heard from many women that they are not fully informed of the risks when considering breast implants. T...
A new drug to treat most cystic fibrosis patients has been approved by the U.S. Food and Drug Administration.
Trikafta (elexacaftor/ivacaftor/tezacaftor) is the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Its list price is $311,000 a year, same as one of the maker's earlier treatments for the genetic disease.