โGame changer for patientsโ: News4JAX receives exclusive look at treatment that delays brain cancer regrowth
GammaTile Therapy is an FDA-approved procedure that wonโt save you from brain cancer, but experts say it will buy you more time and improve your quality of life while you deal with the brain cancer.
Panel backs moving opioid antidote Narcan over the counter
The Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is discussing supplemental new drug application 208411/Sโ006, for NARCAN (naloxone hydrochloride) nasal spray, submitted by Emergent BioSolutions Inc.
A panel of experts answer questions about the COVID-19 booster shot during an FDA meeting
How often should Americans get their booster shot against COVID-19, and how important is the booster to you if youโve already been infected with COVID-19? Those are questions a panel of experts set out to answer during an FDA meeting, the information will be passed on to the CDC.
Federal agencies helping Florida investigate listeria outbreak linked to ice cream
The Food and Drug Administration, along with the Centers for Disease Control and Prevention, is helping the Florida Department of Health and Florida Department of Agriculture and Consumer Services investigate a listeria outbreak linked to ice cream, the FDA said Tuesday.
New website launched to help parents find baby formula amid nationwide shortage
The U.S. Department of Health and Human Services has launched a new website to help parents find baby formula amid a nationwide shortage. Meanwhile, the U.S. Food and Drug Administration is expected to make an announcement on infant formula imports amid the shortage that has sent parents scrambling to keep their babies fed, the federal agency said Friday.
Jacksonville doctor says benefits of Merckโs COVID pill would include convenience, cost
Drugmaker Merck on Monday requested emergency use authorization for its antiviral pill against COVID-Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the worldโs arsenal against the pandemic.
SMILE: An alternative to Lasik
Around 10 million Americans have had Lasik surgery to correct their vision since it was FDA approved 20 years ago. Now a lesser-known vision correction procedure is offering a smaller incision and quicker recovery. Ivanhoe has details on why doctors are considering this Lasik 2.0.
Georgia waiting for CDC recommendations before releasing COVID-19 booster plan
The Georgia Department of Public Health (DPH) said Tuesday it will wait on recommendations from the CDC and the Advisory Committee on Immunization Practices (ACIP) before releasing a plan to administer booster doses of Pfizerโs COVID-19 vaccine in Georgia.
Federal, state sites halt giving J&J vaccine after FDA calls for โimmediate pauseโ
Gateway Mall and other vaccination sites run by the federal government in Jacksonville discontinued giving Johnson & Johnson coronavirus vaccines after a joint call from the CDC and FDA. State-run sites and private pharmacies have also suspended giving J&J doses but continue with the two-shot vaccines.
FDA, CDC call for pause on Johnson & Johnson vaccine after clotting
Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnsonโs coronavirus vaccine after 6 people in the United States developed a rare disorder involving blood clots within about two weeks of vaccination, officials said.
Donโt be choosy about COVID-19 vaccines, health expert says
There are now three COVID-19 vaccines approved for emergency use by the FDA. And absolutely donโt wait for any specific vaccine. Esper said vaccine supply is still scarce, so if youโre eligible and find availability -- donโt wait. They all bring us one step closer to herd immunity and normalcy. When you can get vaccinated, get vaccinated.โEsper said while the trio of COVID-19 vaccines have been deemed safe and effective, theyโre still undergoing testing.
Doctors urge fully vaccinated people to continue practicing COVID-19 safety measures
Those are the questions doctors say theyโre getting most often as more people are getting COVID-19 shots. Those questions were also raised over the weekend when the former Food and Drug Administration Commissioner Dr. Scott Gottlieb said that more and more evidence indicates the COVID-19 vaccine is also preventing transmission of infection. The statement could send a mixed message to some people that they donโt still need to practice COVID-19 safety measures if theyโre vaccinated. โKeep in mind that those clinical trials were not designed to test if the virus is transmissible,โ he said. โIt was designed to test if youโre getting COVID-19 clinically.โAs this is debated, most public health experts have said fully vaccinated persons should continue to wear masks, employ social distancing and continue practicing other public health measures because there had been no evidence the vaccine would prevent transmission as well as infection.
19 more COVID-19 deaths reported in Northeast Florida
The Florida Department of Health reported Saturday an additional 118 deaths of residents or visitors to the state, bringing the total to 29,179, although many of those deaths occurred days or weeks earlier. According to the state, 32 of the additional deaths were in long-term care facilities, which have reported more than 10,000 deaths since the pandemic began -- more than one-third of Floridaโs total. AdSaturdayโs report comes a day after the first case of the U.K. COVID variant was reported in Jacksonville, according to the Duval County Health Department. Florida and Duval County COVID-19 cases per dayThere were 4,681 people in Florida hospitalized on Saturday afternoon with a primary diagnosis of COVID-19. There have now been 2,293,883 people vaccinated in Florida so far and 1,028,315 -- 4.78% of the stateโs population -- have now received both shots.
20 days later, Jacksonville seniors still waiting on call for second dose appointment
Baldwin, 67, was instructed that she would receive a call from the state to set up her second vaccine appointment. If they missed their 21-day, or for the Moderna on the 28-day appointment, they were tracked up to 42 days later to receive it.โโIf you miss 42 days, thatโs probably okay too. Officials did not answer whether they were unable to administer second doses at the same rate as first doses. โWe are prepared to provide a second dose for every person who received a first dose at Regency. โI will follow up with it, but bottom line we have said when the second doses come in, fill your appointments.
Consumer Alert: Parents, check your pantry for this baby food!
JACKSONVILLE, Fla. โ A government investigation revealed several major brands of baby food products contained arsenic and lead. There are in fact no โnormalโ levels so any exposure to any levels of these heavy metals will have a significant impact,โ Goldhagen said. โThe FDA has to take more action to reduce the heavy metals in baby food,โ said Consumer Reports Senior Scientist Michael Hansen. Hansen has spent years advocating for more regulation for baby food. He added that parents searching for peace of mind, should make their own baby food, so they know what their child is eating.
Pet food recalled after more than 2 dozen dogs died, FDA says
A pet food is being taken off shelves after at least 28 dogs died, the FDA announced. The FDA says toxic levels of mold were found in the corn and grains inside some Sportmix pet products. The pet food can cause aflatoxin poisoning with symptoms like sluggishness, loss of appetite, vomiting, jaundice and diarrhea, and in severe cases, it can be fatal. In some cases, dogs and cats can suffer liver damage but not show any symptoms. For now, pet owners should stop using this food and consult their veterinarian immediately.
FDA says some arenโt recommended to take COVID-19 vaccine
Nurse Melissa Valentin shows a dose of the Pfizer-BioNTech COVID-19 vaccine to be applied to medical personnel at the Ashford Presbyterian Community Hospital in San Juan, Puerto Rico, Tuesday, Dec. 15, 2020. (AP Photo / Carlos Giusti)JACKSONVILLE, Fla. โ When the FDA approved Pfizerโs COVID-19 vaccine, the medical community agreed it would help more people than not. However, the vaccine is not recommended for everyone just yet. She said itโs just that right now thereโs no data because no one who falls into these categories were included in the vaccine trials. Itโs important to note that it could be months before a vaccine becomes available for widespread public use, and weโre going to learn more about the vaccines by then.
'Healing is coming': US health workers start getting vaccine
โI feel like healing is coming.โWith a countdown of โ3-2-1,โ workers at Ohio State University's Wexner Medical Center gave initial injections to applause. High-risk health care workers were first in line. It just represents a moral failing,โ said Jennifer Nuzzo, a public health researcher at Johns Hopkins. And later this week, the FDA will decide whether to greenlight the worldโs second rigorously studied COVID-19 vaccine, made by Moderna Inc. โWeโre also in the middle of a surge, and itโs the holidays, and our health care workers have been working at an extraordinary pace,โ said Sue Mashni, chief pharmacy officer at Mount Sinai Health System in New York City.
Florida expecting to get about 120,000 COVID-19 vaccines in coming days
JACKSONVILLE, Fla. โ Florida is expecting to get around 120,000 doses of the vaccine as part of the first phase of distribution. The priority for health officials are hospitals and long-term care facilities. Itโs likely the first doses of an approved COVID-19 vaccine will be sent out within 48 hours. Partnering with the Division of Emergency Management and the Florida National Guard, the department said it will form โstrike teamsโ to get those doses to where theyโre badly needed at long-term care facilities. With 19,500 going to each hospital facility, UF Health in Jacksonville is one of them.
Jacksonville hospital says some requesting COVID-19 vaccine before its arrival
JACKSONVILLE, Fla. โ Health care workers have a big message to the public: Do not come to the hospital right now and ask for the COVID-19 vaccine. Thatโs already happened at UF Health Jacksonville ahead of the vaccineโs rollout. In the end, it comes down to the FDA approving it and the states deciding who gets it first.โWhat do we know about Pfizerโs Covid-19 vaccine? Pfizerโs study does not end if the FDA gives it an emergency use authorization. We are going to learn more about the vaccine and the other vaccines in the pipeline, but itโs the job of the FDA to decide if the benefit outweighs the risk.
Learning more about Pfizerโs COVID-19 vaccine
Dr. Mobeen Rathore, Professor and Chief of Infectious Disease at UF Health Jacksonville, attended the virtual meeting yesterday when an advisory committee voted to recommend the FDA approve Pfizerโs COVID-19 vaccine for emergency use. It is going to be awhile before we know if this vaccine is safe and the effect for children,โ said Dr. Rathore. โI think right now the vaccine is not going to be recommended for pregnant women because the studies were not conducted for pregnant women. If you get the vaccine, Dr. Rathore said that does not mean you should stop wearing a mask or stop socially distancing. Dr. Rathore said while the first dose does provide some protection, it is important that recipients receive both doses to be fully protected.
COVID-19 vaccine: UPS, FedEx ready to deliver
Just like your holiday packages, the COVID-19 vaccine will be sent by air and truck after itโs approved by the FDA. As part of Operation Warp Speed, the military has arranged for two carriers to deliver the doses around the country: FedEx will cover the western part of the United States and UPS will take the eastern half. A local doctor involved in one of the clinical trials being conducted in Jacksonville explained how the Pfizer and Moderna vaccines work. Dr. Michael Koren said itโs important to understand that the vaccine does not inject any live virus into the body. Koren said participants in the clinical trials he is overseeing have experienced a range of reactions to the vaccine, including low-grade fever, headaches and muscle aches.
Mayo Clinic experts back COVID-19 vaccines ahead of FDA approval
JACKSONVILLE, Fla. โ The FDA will start its review Thursday of Pfizerโs COVID-19 vaccine, which is said to be 95% effective, according to the company. Ahead of Thursdayโs meeting, the FDA says its analysis found the Pfizer vaccine is safe, and health experts with Mayo Clinic echoed that. โWe are very confident that the Pfizer vaccine and Moderna vaccine will get the emergency use authorization,โ said Dr. Abinash Virk with Mayo Clinic. Virk said both vaccines are safe overall, but may cause some mild symptoms. It is important to note, that it is not uncommon to advise people with severe allergies to be cautious when it comes to new vaccines.
Consumer Alert: Avoid COVID-19 vaccine and distribution scams
Scammers may try to exploit the sense of urgency surrounding the distribution of the COVID-19 vaccine to swindle those trying to protect their health. I am asking all Floridians to be on the lookout for vaccine-related scams and report fraud to our office.โMoody released the following tips to help Floridians avoid COVID-19 vaccine-related scams:Know that no COVID-19 vaccine has been approved by the FDA as of the time of this Consumer Alert; therefore, any attempt to sell a vaccine right now is not legitimate. Never send money or financial information to anyone offering a COVID-19 vaccine or claiming the ability to expedite the process. The FDA will host a meeting regarding vaccines and related biological products on Thursday to discuss Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine. To view the latest alerts and to stay up-to-date on COVID-19 related scams, visit the Attorney Generalโs Consumer Alert webpage by clicking here .
The Latest: S Korea begins stronger limits in some areas
In September, the district reported about 13 new coronavirus cases weekly, mostly involving teachers and staff, when it first opened early childhood education classes. ___ST. PETERSBURG, Fla. โ Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the stateโs rolling seven-day average for new coronavirus cases was more than nine times higher Wednesday than it was than when her first order took effect. Officials began instituting local shutdowns in neighborhoods where coronavirus cases were rapidly rising. There were 5,102 cases reported in Minnesota on Wednesday, along with 67 deaths.
Arsenic in rice can cause cancer
New steps for cooking rice can reduce the health risks of consuming too much arsenic in the diet. Cooking rice in a certain way removes over 50 percent of the naturally occurring arsenic in brown rice, and 74 percent in white rice, according to new research. Steps to reduce arsenic when cooking rice. While brown rice has higher arsenic concentrations, white rise is considered more of a risk due to a higher consumption rate. According to the FDA, eliminating rice and rice products from the diets of infants and children under 6 years old lowers the chance of developing lung or bladder cancer from arsenic contamination by approximately 6% over their lifetime.
Fast & accurate: Working on a better COVID-19 antibody test
A rush to get COVID-19 antibody tests out may have set us back in our efforts to accurately test for the virus. Test, after test, after test, is failing to accurately test for COVID-19 antibodies. To create an accurate antibody test, you have to create a protein that antibodies will be attracted to. The information they get from this test may also help determine how long antibodies will last. If youโre hospitalized, youโre on ICU, youโre probably going to come out with antibodies,โ Frazer-Abel said.
FDA warns of hand sanitizer packaged in food, drink containers
FDA warns of hand sanitizer packaged in food, drink containersPublished: August 27, 2020, 6:52 pmThe U.S. Food and Drug Administration is warning people about alcohol-based hand sanitizers that are being packaged in what appears to be food or drink containers.
FDA warns of hand sanitizer packaged in food, drink containers
JACKSONVILLE, Fla. โ The U.S. Food and Drug Administration is warning people about alcohol-based hand sanitizers that are being packaged in what appears to be food or drink containers. โI am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages. The FDA said it has also found hand sanitizers that contain food flavors, such as chocolate or raspberry. โItโs dangerous to add scents with food flavors to hand sanitizers, which children could think smells like food, eat and get alcohol poisoning,โ Hahn said. The FDAโs recommendation is to avoid any hand sanitizer that could be mistaken for something else.
Duval schools forced to round up 2,000 bottles of hand sanitizer after recall
JACKSONVILLE, Fla. The Duval County school district had to remove around 2,000 bottles of hand sanitizer from schools after the FDA issued a recall, the district told News4Jax. According to a Duval County Public Schools spokeswoman, the hand sanitizer products purchased by the district were put on the recall list due to the inclusion of methanol in the ingredients. Even with the recall and the removal of this product, we should have hand sanitizer in each classroom, the district told News4Jax. Classrooms are also equipped with one-gallon bottles of hand sanitizer that do not have that ingredient.The district said if for some reason a teacher does not have access to hand sanitizer, he or she can inform the school principal so that the district can fill that gap. School for Duval County students begins Thursday and hand sanitizer is just one of the many COVID-19 precautions put in place by the district.
FDA updates poison warning to include 87 hand sanitizers -- mostly from Mexico
The FDA warns of almost 90 hand sanitizer brands that have been found to contain the toxic chemical methanol. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or even life-threatening when ingested. Out of the 87 hand sanitizers the FDA has found to contain the toxic substance, all but one was manufactured from the same country. The only hand sanitizer brand on the list not manufactured in Mexico comes from Leipers Fork Distillery in Tennessee. We have had a few cases where children were hospitalized and needed intense treatment because they got into bottles of hand sanitizer that had the methanol in it, he said.
Sweet Tomatoes closing for good amid coronavirus pandemic, report says
Sweet Tomatoes, also known at Soup Plantation in other parts of the U.S., is closing all of its restaurants permanently, according to the San Diego Tribune. The self-service eatery will close all 97 restaurants it announced Thursday, WKMG reports. San Diego based Garden Fresh Restaurants, which owns Sweet Tomatoes, has been trying to salvage its operations but the coronavirus pandemic took its toll on the buffet-style eatery as the FDA put out recommendations to discontinue this style of serving. And Iโm not sure the health departments are ever going to allow it. Sweet Tomatoes opened its first store in Florida in 1990 in Palm Harbor.
How long will it take to have a vaccine for COVID-19?
How long do experts forecast for a COVID-19 vaccine to be created? Moderna, one of the U.S. companies working on a vaccine, said it could have a vaccine ready for a phase one clinical trial in people within three months. Phase I vaccine trials - This is the first attempt to try out the vaccine in a small group of adults -- usually 20 to 80 subjects. Phase II vaccine trials - The vaccine is tested on a larger group of individuals to assess the safety of the vaccine and method of delivery. Phase III vaccine trials - If the vaccine passed the first two phases, itโs then tested on tens of thousands of people to make sure there are few adverse side effects and the vaccine is effective.
Sanofi issues voluntary recall of Zantac OTC medication
Drew Angerer/Getty Images(CNN) - Sanofi says it's voluntarily recalling its over-the-counter heartburn drug Zantac in the U.S. and Canada because of concerns of potential cancer risks. The FDA has said that some ranitidine medications -- including those known by the brand name Zantac -- contain low levels of an impurity that could cause cancer. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan. Yet that study also noted that research into long-term cancer risk is needed. "Sanofi encourages anyone using Zantac OTC to speak with their health care providers or pharmacists if they have any additional questions," the company's statement said.
NY to require menstrual product packages to list all ingredients
Andrew Cuomo signed a bill requiring menstrual product packages sold in the state to include a list of ingredients in the products. ALBANY, N.Y. - New York just became the first state to require an ingredient list on menstrual product packages, in a move the governor says will "empower women." New York is the first state to legislate this requirement, which people have been advocating for years. "Practically every product on the market today is required to list its ingredients, yet these items have inexplicably evaded this basic consumer protection," Cuomo said in a statement. "Even if they list some ingredients, they may not be listing all of them," he said.
FDA takes major step toward approving first peanut allergy treatment
Copyright 2019 CNNWASHINGTON, D.C. - The US Food and Drug Administration's Allergenic Products Advisory Committee on Friday voted in favor of approving a treatment for peanut allergies in children. While the advisory committee has voted in favor of the treatment, the FDA will make its final approval by January. The agency frequently follows the lead of the advisory committee. If approved, this will become the first FDA approved treatment for peanut allergy. The American College of Allergy, Asthma and Immunology says that more than 2.5% of American children are allergic to peanuts.
Vape shop owner calls for crackdown on black-market vape products
But the lack of specifics associated with this illness is putting businesses that sell vape products on their heels as they grapple with public perception. Ernesto Fragoso, who owns New Start Vapor Company in Jacksonville, believes in the products he sells and stands behind them. Fragoso, who uses vape products daily, invited News4Jax Consumer Investigator Lauren Verno into his store on Tuesday to learn more about vaping. "Vaping black market products is not safe and should not be a thing," Fragoso told News4Jax. The products Fragoso sells only contain flavor and nicotine.
FDA warns companies to stop illegally marketing vape products
Matt Cardy/Getty ImagesWASHINGTON, D.C. - The FDA began to crack down on illegally marketed tobacco products Thursday, issuing warning letters to four companies for allegedly selling e-liquids and hookah tobacco without legal authorization. The products, according to the FDA, lack the necessary marketing authorization to be sold in the United States. Together, they sold 44 flavored e-liquid and hookah products that lacked necessary authorization, the FDA said. A federal judge ruled in May that the FDA acted illegally by allowing e-cigarettes to remain on the market until 2022 before companies applied for FDA authorization. "The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products," Sharpless said at the time.
Elizabeth Holmes Confidently Strides Out of Court After Legal Win
Elizabeth Holmes appeared in court Wednesday, where she won a request to quickly be granted access to millions of FDA documents in order to pull together her defense ahead of next year's trial. But the FDA was concerned that expediting the process of turning over the documents could potentially out a confidential informant. Holmes was photographed confidently striding out of federal court following the legal victory. RELATED STORIESElizabeth Holmes' New Hairdo Raises Eyebrows as Trial Is Set for Next SummerDid Elizabeth Holmes Get Married in Secret in an Effort to Get Pregnant Before Trial? Elizabeth Holmes Moves Out of San Francisco Apartment Where Inside Edition Tracked Her Down
Salmonella outbreak could be caused by pig ear dog treats, CDC says
The CDC reported Wednesday it and the FDA are investigating an outbreak of salmonella across 13 states -- and it's linked to contact with pig ear dog treats. (CNN) - Could the treats you're feeding your dog be making you or your family sick? The CDC reported Wednesday it and the FDA are investigating an outbreak of salmonella across 13 states -- and it's linked to contact with pig ear dog treats. In CDC interviews with 38 of those infected, 34 said they had been in contact with a dog before getting sick. Separately, 17 people of 24 interviewed reported contact with pig ear dog treats or dogs fed those treats.
San Francisco bans e-cigarette sales
But will the strict new policy make San Francisco healthier? Because no manufacturers have done that yet, the law will halt all vape sales in about seven months. Undergoing FDA review, which the new San Francisco law demands, would require companies like Juul to provide data to back up their marketing claims, said Lempert. San Francisco's city attorney, Dennis Herrera, echoed those concerns after San Francisco's law passed. "This is a decisive step to help prevent another generation of San Francisco children from becoming addicted to nicotine," he said.