Posts tagged with "FDA"

How long are Thanksgiving leftovers safe to eat?

November 29, 2021

If your turkey lurks for just a little too long in your refrigerator, is it still okay to eat it? And what about stuffing, cranberry sauce, pie, and all your other holiday favorites?

All cooked leftovers should be refrigerated or frozen within two hours after preparation, according to the Food and Drug Administration. And as a general rule of thumb, leftovers should be eaten or thrown out four days after refrigeration. If you freeze your food, it can last from two to six months, reports HuffPost.

In addition to taking food safety into account, these recommendations also consider the quality of your food. In other words, leftover turkey tastes pretty rank after a week, even if it doesn’t give you food poisoning.

If you’re craving more specifics besides “no longer than four days,” here’s what the U.S. Department of Agriculture’s Food Safety and Inspection Service suggests:

  • Discard any turkey, stuffing, or gravy that’s been left out at room temperature for longer than two hours, or one hour in temperatures above 90 degrees Fahrenheit.
  • Divide leftovers into smaller portions. Refrigerate or freeze in covered shallow containers for quicker cooling.
  • Use refrigerated turkey, stuffing, and gravy within three to four days.
  • If freezing leftovers, use within two to six months for best quality. Turkey, specifically, will last for four months in the freezer.

As for desserts, in general, fruit, pumpkin, pecan, custard, and chiffon pies can be safely stored in the refrigerator for three to four days, according to FDA guidelines. But many pies ― especially fruit ― are best eaten within just a couple of days.

Essentially, you have until the Monday after Thanksgiving to enjoy your delicious leftovers from the fridge. After that, chuck ’em.

Research contact: @HuffPost

FDA moves closer to clearing Moderna and J&J COVID booster shots this week

October 12, 2021

Millions of Americans will be one step closer to receiving a COVID-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday, October  14 and 15, to debate extra doses of the Moderna and Johnson & Johnson vaccines, reports CNBC.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized COVID booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions; and those who work or live in high-risk settings, like health and grocery workers.

More than 7 million Americans have received a booster dose in the United States as of Saturday, October 9, according to the latest data available from the Centers for Disease Control (CDC).

Members on independent committees by the FDA and CDC and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna or J&J’s shots.

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.

The CDC’s next vaccine advisory meeting is scheduled to take place from October 20 to October 21, when it’s expected to discuss the boosters.

Research contact: @CNBC

Like falling off a log? Viral milk crate challenge on TikTok is denounced by orthopedists

August 26, 2021

The latest challenge to take the Internet by storm involves precariously stacked milk crates, balance—and some painful falls, The Guardian reports.

To complete the challenge, which recently started on TikTok, participants face a set of milk crates piled up in the shape of a pyramid—and attempt to climb to the top and then back down again without toppling over.

As videos of people falling painfully go viral on social media and rack up millions of views, doctors across the US are coming out to warn people of the dangerous injuries that can occur.

“It’s perhaps even worse than falling from a ladder,” Shawn Anthony, an orthopedic surgeon at Mount Sinai Hospital in New York City told The Washington Post this week, adding, “It’s very difficult to brace yourself from the falls I’ve seen in these videos. They’re putting their joints at an even higher risk for injury.”

With many hospitals nationwide already overwhelmed by COVID-19 patients and running short on space and staff, health departments are urging people to reconsider their choices before taking on the challenge.

George Gantsoudes, a Virginia-based orthopedic surgeon, wrote on Twitter: “The orthopaedic surgeries required to fix problems caused by this may fall under the umbrella of ‘elective surgeries’.”

On Monday, the Baltimore city health department tweeted: “With COVID-19 hospitalizations rising around the country, please check with your local hospital to see if they have a bed available for you, before attempting the #milkcratechallenge.”

The Food and Drug Administration (FDA) also weighed in on the challenge after comedian Conan O’Brien  joked about how he needed federal officials to grant permission to the challenge before attempting it—playing off the FDA’s approval of Pfizer’s COVID-19 vaccine earlier this week.

“Waiting for FDA approval before I take the Milk Crate Challenge,” O’Brien tweeted on Monday. The FDA responded shortly after, writing: “Although we regulate milk, we can’t recommend you try that. Perhaps enjoy a nice glass of 2% and return all those crates to the grocery store?”

The milk crate challenge is the latest of a slew of dares that have gone viral on TikTok. In recent months, the video-sharing platform has seen a rise of dangerous challenge—among them, the blackout challenge, which encouraged young people to hold their breath until they passed out, and the Benadryl challenge, which challenged young people to intentionally consume large amounts of the antihistamine to induce hallucinations.

In a statement about the most recent challenge, a TikTok spokesperson said: “TikTok prohibits content that promotes or glorifies dangerous acts, and we remove videos and redirect searches to our community guidelines to discourage such content. We encourage everyone to exercise caution in their behavior whether online or offline.”

Research contact: @guardian

Shot heard round the world: FDA gives full approval to Pfizer-BioNTech COVID-19 Vaccine

August 24, 2021

The COVID-19 vaccine from Pfizer  and partner BioNTech received full approval from U.S. regulators on Monday, August 23, which many public health officials and vaccine experts hope will encourage hesitant populations to get the shot, reports The Wall Street Journal.

The Food and Drug Administration’s clearance of the shot for people 16 years and older is the agency’s first full approval of a COVID-19 vaccine. The decision was expected this week, the Journal and other news outlets reported.

The vaccine was first cleared in December by the FDA on an emergency-use basis for people 16 years and older after the drugmakers showed it to be highly effective at preventing symptomatic COVID-19. The two-dose shot, resulting from the fastest vaccine development ever in the West, has since become the most-received COVID-19 vaccine in the United States.

The vaccine was authorized for children as young as 12 years in May. Pfizer plans to request full approval for that group once it has collected and analyzed six months of safety data from clinical-trial subjects, according to the company.

Pfizer—which will market the vaccine under the name Comirnaty—is now permitted to market the vaccine to doctors, providers, and the general public, as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The vaccine is also eligible for off-label prescriptions, which could include booster doses, according to the FDA.

The FDA, under pressure to give COVID-19 vaccines full approval swiftly, made its decision less than four months after Pfizer began its approval submission. The process of reviewing applications normally takes up to approximately ten months.

The FDA said its review found the vaccine to be safe and effective in preventing COVID-19 as well as severe disease, hospitalization, and death. The most common side effects by clinical trial participants who received the vaccine included fatigue, headache, joint pain, chills and fever.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S.A. and that the public is counting on safe and effective vaccines,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the United States.”

The approval comes as U.S. hospitals are seeing a surge in cases tied to the contagious Delta variant, and as the government weighs when vaccinated adults should receive additional doses (the consensus: eight months after the second shot).

Pfizer already has submitted data to the FDA showing that a third dose of its vaccine boosts the immune system against the original virus and against the Beta and Delta variants to higher levels than the standard two-dose regimen. Pfizer plans to submit a request for booster authorization as an amendment to the full approval.

Of the three authorized vaccines in the United States, only Pfizer had submitted all the required information to the FDA, according to the companies, and analysts expected it to be the first to receive clearance.

Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnsonwhose shot was authorized in February, has said it plans to file for full approval later this year.

Research contact: @WSJ

In controversial decision, FDA approves new Alzheimer’s disease drug

June 9, 2021

On June 7, the U.S. Food and Drug Administration approved the use of the experimental drug aducanumab for patient treatment during the early phases of Alzheimer’s disease—overriding the conclusion of an FDA advisory committee last year that there was not enough evidence to support the effectiveness of the treatment.

According to a report by CNN, the drug was developed for patients with mild cognitive impairment, not severe dementia, and intended to slow progression of Alzheimer’s disease —not just ease symptoms.

The FDA has not approved a novel therapy for Alzheimer’s disease since 2003.

The FDA approved aducanumab, also known as Aduhelm, using its “accelerated approval” program, which allows for the earlier approval of a drug for a serious or life-threatening illness even though more study into the drug’s benefits may be needed.

“There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in Monday’s announcement.

“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” she said, noting that the FDA ultimately decided to use accelerated approval and “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

“FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside,” Cavazzoni said.

In November, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee was asked to vote on several questions about evidence of the drug’s effectiveness. In response to a question about whether it was reasonable to consider data from one positive study as the primary evidence of aducanumab’s effectiveness for the treatment of early Alzheimer’s disease, none of the committee members voted yes; ten voted no and one was uncertain.

The committee’s opinions were then left with the FDA as the agency mulled whether to approve the drug or pump the brakes.

“In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Cavazzoni said on Monday. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

The pharmaceutical company Biogen and its Japanese partner Eisai developed aducanumab—administered through intravenous infusion to treat early Alzheimer’s disease. The drug was developed for patients with mild cognitive impairment, not severe dementia.

Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and NewYork-Presbyterian in New York, who had patients in the original aducanumab clinical studies, told CNN the drug targets the earliest symptomatic phase of the disease, called mild cognitive impairment due to Alzheimer’s. Treatment of the pre-dementia period was the focus of the FDA’s decision.

“We have to really temper expectations and explain to people that this drug is meant for the earliest symptomatic phases,” he said. “It pains me to say this, but if I have a severe Alzheimer’s patient that can no longer speak or interact much with others and their family member is begging me to give them this drug, I won’t be able to do it.”

Some groups, including the nonprofit Public Citizen’s Health Research Group, argued that the FDA should not approve aducanumab for treatment of Alzheimer’s disease due to lack of evidence of its effectiveness.

There have also been concerns around cost: Biogen announced on Monday that the wholesale cost of treatment with aducanumab—which requires an infusion once every four weeks—is about $4,312 per infusion, making the annual cost around $56,000 for a high dose.

However, the participating companies said, “Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations,” the company noted in its announcement. “For qualified, commercially insured ADUHELM patients, co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0. Patients who are covered by Medicare through a Medicare Advantage plan have a maximum annual out-of-pocket cap.”

In May, the Institute for Clinical and Economic Review released a draft report estimating that the drug should cost between $2,560 to $8,290 per year, and noted that “the evidence is insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.

Other organizations, such as the Alzheimer’s Association, have supported approval of the drug.

“This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, the association’s president and CEO, said in a post on Twitter on Monday.

Research contact: @CNN

Chlorophyll water is all over TikTok. But is it actually good for you?

My 13, 2021

Chlorophyll water has been gaining popularity since 2016, when celebrities began touting its health and beauty benefits. Now, TikTokers are claiming in viral videos that it can help treat acne and inflamed skin, reduce body odor, prevent cancer, and support gut health, HuffPost reports.

The most popular TikToks―which have garnered 1.5 million to 2 million “likes” to date―promote chlorophyll water’s transformative effects on the skin. In the videos, TikTokers show their skin’s progress over time and advise adding liquid chlorophyll drops to water rather than applying chlorophyll topically or swallowing a chlorophyll pill.

“Drinking liquid chlorophyll seems to hit on people’s intuitions about naturalness and purity, because you are taking water and adding something that comes from plants, which are instinctively viewed as pure,” noted Andrew Shtulman, a professor of Psychology at Occidental College in Los Angeles.

It is also easier to swallow chlorophyll than, say, cook green vegetables or exercise. After all, these health-boosting activities “take more effort, or we might not have the resources to purchase the materials or access to a space where we need to do them,” Shtulman said.

That said, HuffPost cautions, don’t expect it to be the cure TikTok users are making it sound. Like most things related to your well-being, there isn’t one magical solution or a quick fix. Here’s what to know:

First, it is important to remember that dietary supplements are not regulated or required to undergo Food and Drug Administration approval, said Judy Simon, a registered dietitian and nutritionist and adjunct faculty member at the University of Washington.

“Anyone can make all kinds of claims about chlorophyll supplements,” said Simon, so approach cautiously when you see them on your TikTok “For You” page.

To assess the true effectiveness of liquid chlorophyll, you need to look at chlorophyllin, a semi-synthetic form of chlorophyll found in liquid chlorophyll that is different from the natural version contained in plants, Simon said. This form allows it to be mixed into water and dissolve well.

However, HuffPost reports,the limited number of human studies on chlorophyllin’s effect on skin focus on topical application, as opposed to ingestion, and these studies involve only 10 people or fewer.

Board-certified dermatologist Joyce Park emphasized that better research is needed to uncover the benefits of using topical or liquid chlorophyll supplements.

While she did note that chlorophyll may hold potential benefits for the skin because “its antioxidant properties help with anti-aging and it also has anti-inflammatory properties to help treat acne,” the research remains limited.

Ultimately, Park advised against relying on chlorophyll as your sole antioxidant or acne treatment. And you can reap the benefits of natural chlorophyll by eating green vegetables, drinking matcha, or consuming spirulina, Simon said.

Existing studies are still inconclusive when it comes to drinking liquid chlorophyll for other health reasons. Some viral videos claim it can do everything from reduce body odor to prevent types of cancer, but there’s no solid evidence to suggest this is true.

A single study on mice did find that drinking chlorophyllin mixed with water may regulate the gut microbiome. But Simon said this doesn’t provide enough evidence for her to recommend it to her clients to boost their gut health.

After drinking chlorophyll water, you may experience side effects such as diarrhea or green-colored stools. Some experience an allergic reaction or have stomach cramps, prompting some people to seek medical help.

Drinking chlorophyll water isn’t likely to damage your skin, Park said. But it is still unclear whether chlorophyllin has other adverse impacts on your body when you use it long-term, since the only safety data that currently exists is for taking 300 milligrams daily for up to three months, Simon said.

And for those who are pregnant or breastfeeding, safety data does not yet exist, Simon said. If you fall into one of these groups, your doctor will likely advise you to avoid drinking chlorophyllin during these periods.

You also may be advised to avoid it if you take medications that increase your sensitivity to sunlight, like some antidepressants or blood pressure medication, as chlorophyllin can increase your chances of sunburn.

Research contact: @HuffPost

Pfizer’s new at-home pill to treat COVID could be available by the end of this year

April 28, 2021

Pfizer’s experimental oral drug to treat COVID-19 at the first sign of illness could be available by the end of the year, CEO Albert Bourla told CNBC on Tuesday, April 27.

In March, the company—which developed the first FDA-authorized COVID-19 vaccine in the United States in cooperation with German drugmaker BioNTech—began an early-stage clinical trial testing a new antiviral therapy for COVID. The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens, such as HIV and hepatitis C.

If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed nationwide by year-end, Bourla told CNBC’s “Squawk Box.”

Health experts say the drug, taken by mouth, could be a gamechanger because people newly infected with the virus could use it outside of hospitals. Researchers hope the medication will keep the disease from progressing and prevent hospital trips.

In addition to the drug, Pfizer is still testing its vaccine in 6-month to 11-year-old children. Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say.

Earlier this month, the company asked the FDA to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% effective in a study.

Bourla told CNBC on Tuesday he is “very optimistic” that the FDA will approve the use of the shot in adolescents.

Research contact: @CNBC

Johnson & Johnson COVID-19 vaccine pause likely to last only a few days

April 14, 2021

On Tuesday morning, federal officials said they expected the recommended pause in administration of the Johnson & Johnson COVID-19 vaccine to last only a few day—and said it should not impact the United States’ vaccination goals, Roll Call reports.

The Food and Drug Administration and the Centers for Disease Control and Prevention announced early on March 13 that the they were recommending a pause in Johnson & Johnson COVID-19 vaccinations after six female patients out of the 6.8 million Americans who had received the vaccine to date reported the development of a rare type of blood clot six to 13 days after vaccination. The women were between the ages of 18 and 48.

The Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, told reporters on a call that the pause is necessary to educate providers about the type of blood clot caused by the Johnson & Johnson vaccine, called a cerebral venous sinus thrombosis.

Standard blood clot treatment does not work for this type of clot, which, according to Johns Hopkins Medicine, occurs in the brain’s venous sinuses. Such a clot prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage—and leading tio a life-threatening stroke.

The experts warn that, if the standard course of treatment is followed for a cerebral venous sinus thrombosis, it could cause further harm or even be fatal, Roll Call reports.

Marks said there is no known link to birth control or contraceptives. The only hypothesis health officials mentioned is that the adenovirus vaccine creates an extreme immune reaction in some people that causes platelet clots.

The CDC’s Vaccine Advisory Committee on Immunization Practices is set to meet on Wednesday, March 14, to review these cases and discuss the potential significance.

CDC Principal Deputy Director Anne Schuchat told reporters that anyone who was vaccinated with this one-shot vaccine a month ago or more should not worry. But anyone who received the Johnson & Johnson coronavirus vaccine in the past few weeks should watch for symptoms including severe headaches, leg pain, or abdominal pain that differs from typical post-vaccination symptoms.

Acting FDA Commissioner Janet Woodcock said these reactions are extremely rare and should not deter Americans from getting vaccinated for COVID-19. The pause is due to regular safety monitoring, she said.

“The message to patients who haven’t been vaccinated is to continue to get vaccines that may still be available to them,” Woodcock said.

White House COVID-19 Response Coordinator Jeff Zients told reporters the delay would not have a significant impact on the U.S. vaccination plan. The one-shot vaccines from Johnson & Johnson make up less than 5% of recorded shots in arms to date.

The U.S. has secured enough doses of the COVID-19 vaccines from Moderna and Pfizer to continue vaccinating 3 million people per day, Zients said. States and the federal government plan to work quickly to get anyone scheduled for a Johnson & Johnson vaccine rescheduled for a two-dose shot by Moderna or Pfizer.

The pause will immediately impact the places that receive vaccines directly from the federal government: retail pharmacies, community vaccination clinics, mobile vaccinations units and FEMA-run sites.

The move could shutter some mass vaccination sites. The Federal Emergency Management Agency said it is working with states to find other vaccines.

“FEMA is committed to helping the President’s goal to ensure everyone who wants to be vaccinated can be. In alignment with the Centers for Disease Control and Prevention and Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine, effective immediately FEMA will stop administering this vaccine at our pilot Community Vaccination Clinics, as well as via our Mobile Vaccine Units,” said Acting Administrator Bob Fenton in an emailed statement. “We are working with our state partners to determine the path forward and find alternative vaccine options for these sites.”

Georgia, North Carolina, and Colorado have reportedly shut vaccination sites because of adverse events experienced by people receiving the Johnson & Johnson vaccine.

Several states—including Maryland, New York, and Ohio—confirmed Tuesday morning that they would pause administering the vaccine.

Research contact: @rollcall

Waste is a terrible thing to waste: Ikea’s glossy (and free) new cookbook puts food scraps on the menu

April 6, 2021

Summery corncob soup, ‘plantcakes’ made with broccoli and carrot greens, and corn husk smoked chicken with fried corn silk are just a few of the inventive recipes in Ikea’s “The Scraps Book”—a cookbook dedicated to food preparation with the little things we usually throw away, The Chicago Tribune reports.

The Swedish home design brand collaborated with ten renowned chefs to address food waste and to show how easy it is to use food scraps like kale stems, banana peels and spent coffee grounds to create show-stopping meals. The beautifully designed ebook is full of stunning food photos of the 50 easy-to-follow recipes, along with tips like how to build your own backyard compost.

According to a Food and Drug Administration report, food waste is estimated at between 30% and 40% of the food supply in the United States, and the report lists wasted food as the single largest category of material placed in municipal landfills.

In 2016, the Department of Agriculture and Environmental Protection Agency announced the formation of the U.S. Food Loss and Waste 2030 Champions group and set a goal of reducing food waste by 50% by the year 2030, the Tribune notes.

.“ScrapsBook” is free for download at Apple Books, Google Play, and Ikea.com. The eBook is available to everyone, and Ikea Family members will be automatically entered to win a limited edition hardcover copy of the 214-page book. As Ikea says, “Waste is a terrible thing to waste”

Research contact: @chicagotribune

GlaxoSmithKline requests emergency authorization from FDA for COVID monoclonal antibody drug

March 29, 2021

On Friday, March 26, GlaxoSmithKline and Vir Biotechnology  applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug, CNBC reports.

The companies are requesting clearance for use by high-risk patients, age 12 and older.

The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of COVID-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from COVID by 85% compared with a placebo. The trial results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

The companies started testing the antibody on early-stage COVID patients in August, CNBC notes—hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already authorized for use—from Regeneron and Eli Lilly—are being underutilized.

GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to COVID patients as soon as possible.

Research contact: @CNBC