INSIDER
McDonald’s says slivered onions believe to be tied to E. Coli outbreak were distributed to 900 restaurants in 12 states
Read full article: McDonald’s says slivered onions believe to be tied to E. Coli outbreak were distributed to 900 restaurants in 12 statesMcDonald’s says they believe slivered onions supplied from a California-based produce company have been isolated as the likely cause of the E. Coli outbreak tied to the company’s Quarter Pounders.
Where to donate blood in the Houston area ahead of Hurricane Milton
Read full article: Where to donate blood in the Houston area ahead of Hurricane MiltonWith Hurricane Milton threatening Florida, the need for blood donations has become urgent due to potential disruptions in blood drives leading to shortages.
Understanding breast cancer risk factors, and answering other questions Houstonians might have
Read full article: Understanding breast cancer risk factors, and answering other questions Houstonians might haveThis year alone, more than 360,000 people will be diagnosed with breast cancer but there is hope: early detection is key to increase survival chances.
Women with dense breasts will now be notified after routine mammograms, here’s why it should save lives
Read full article: Women with dense breasts will now be notified after routine mammograms, here’s why it should save livesStarting September 10th, women will be notified if their mammograms show dense breast tissue, which can obscure cancer detection.
This Houston compounding pharmacy is making weight loss medications like Semaglutide more affordable
Read full article: This Houston compounding pharmacy is making weight loss medications like Semaglutide more affordableThe FDA explains on its website that when a drug is in shortage, compounding pharmacies may be able to prepare a compounded version if they meet certain Federal Food, Drug, and Cosmetic Act requirements. As of May 2023, Ozempic and Wegovy are both listed on the FDA’s Drug Shortages list, and as a result, Houston-based Empower Pharmacy began offering compounded GLP ones. So what does this mean and what do you need to know?
‘Still so many unknowns’: Houston mental health expert weighs in as FDA set to decide on MDMA as treatment for PTSD
Read full article: ‘Still so many unknowns’: Houston mental health expert weighs in as FDA set to decide on MDMA as treatment for PTSDNew developments are emerging in the effort to help millions of people who suffer from post-traumatic stress disorder, including our veterans.
Takeaways from Supreme Court ruling: Abortion pill still available but opponents say fight not over
Read full article: Takeaways from Supreme Court ruling: Abortion pill still available but opponents say fight not overThe Supreme Court unanimously upheld access to a drug used in the majority of U.S. abortions, though abortion opponents say the ruling won’t be the last word in the fight over mifepristone.
Supreme Court seems likely to preserve access to the abortion medication mifepristone
Read full article: Supreme Court seems likely to preserve access to the abortion medication mifepristoneThe Supreme Court seems likely to preserve access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion case since conservative justices overturned Roe v. Wade two years ago.
Congressional leaders come out with 6 spending bills in a drive to avoid a partial shutdown
Read full article: Congressional leaders come out with 6 spending bills in a drive to avoid a partial shutdownCongressional leaders have come out with a package of six bills setting full-year spending levels for some federal agencies.
Are pharmacy medications safe and secure? Understand the vetting process of distributing pharmaceuticals
Read full article: Are pharmacy medications safe and secure? Understand the vetting process of distributing pharmaceuticalsWhile a majority of overdoses are from illicit drugs, a concern among many is knowing the medications you receive from pharmacies are safe and secure.
FDA warns against buying, using eyedrops made in ‘insanitary conditions’
Read full article: FDA warns against buying, using eyedrops made in ‘insanitary conditions’The Food and Drug Administration on Monday expanded its warning not to buy or use eyedrops sold by several major retailers, sometimes under their own brand names.
RSV vaccines available for adults and babies, local hospital hopes it lowers hospitalizations from the disease
Read full article: RSV vaccines available for adults and babies, local hospital hopes it lowers hospitalizations from the diseaseFor the first time ever, people older than 60 and pregnant women can get a vaccine to protect against RSV, a contagious and deadly virus.
FDA rejects first needle-free alternative to EpiPens, calling for more research
Read full article: FDA rejects first needle-free alternative to EpiPens, calling for more researchThe Food and Drug Administration, in a surprise move, has decided not to approve an epinephrine nasal spray that would have been the first needle-free alternative to epinephrine autoinjectors, including EpiPens.
FDA could greenlight new COVID boosters as early as Friday
Read full article: FDA could greenlight new COVID boosters as early as FridayThe Food and Drug Administration plans to greenlight updated versions of the Covid booster as early as Friday, according to four people familiar with the agency’s plans.
ADHD drug shortage affecting families as kids go back to school
Read full article: ADHD drug shortage affecting families as kids go back to schoolPrescription stimulants are used to treat ADHD, binge eating disorders, and narcolepsy. However, a shortage of these prescriptions is frustrating patients and their families.
U.S. Supreme Court delays decision on abortion pill until Friday night
Read full article: U.S. Supreme Court delays decision on abortion pill until Friday nightThe Supreme Court has given itself until 11:59 p.m. on Friday to decide whether a Texas U.S. district judge’s ruling that found the abortion drug Mifepristone unsafe should stand.
Kamala Harris rallies as high court eyes abortion pill rules
Read full article: Kamala Harris rallies as high court eyes abortion pill rulesVice President Kamala Harris is urging Americans to take action during “a critical point in our nation’s history” as thousands of people protested new limits to abortion rights in demonstrations across the country.
Missouri to limit gender-affirming care for minors, adults
Read full article: Missouri to limit gender-affirming care for minors, adultsMissouri’s attorney general has announced new restrictions on gender-affirming care for adults in addition to minors in a move that is believed to be a first nationally and has advocacy groups threatening to sue.
The growing need for weight loss medication, which ones work and who shouldn’t take them
Read full article: The growing need for weight loss medication, which ones work and who shouldn’t take themWhile the weight loss side effect of Ozempic made it challenging for diabetes patients to get their prescriptions, it also sheds light on the need for more weight loss drugs.
DeSantis flexes executive powers while eyeing White House
Read full article: DeSantis flexes executive powers while eyeing White HouseFlorida Gov. Ron DeSantis has advanced elements of his aggressive conservative agenda though the use of executive power, drawing on appointees, state boards and the state Constitution as he builds toward an expected presidential candidacy.
Abortion pill on hold: Activists protest in Montrose following federal judge’s decision
Read full article: Abortion pill on hold: Activists protest in Montrose following federal judge’s decisionAn anti-abortion organization has planned a protest in front of a Montrose-area Walgreens on Saturday following a federal judge’s decision to put a hold on the federal approval of mifepristone overnight Friday.
Research team at UT Austin reveals new blood test to identify brain injuries
Read full article: Research team at UT Austin reveals new blood test to identify brain injuriesA research team at the University of Texas at Austin’s PsyBrain Lab announce the new FDA approved laboratory blood test for traumatic brain injury in the United States.
KPRC 2 Investigates Buyer Beware: Dangers of buying prescription drugs online
Read full article: KPRC 2 Investigates Buyer Beware: Dangers of buying prescription drugs onlineRising costs, coupled with high health insurance deductibles have some people turning to the internet to find cheaper drug prices. Investigator Amy Davis looks into what you need to know about the dangers of buying prescription drugs online.
FDA warns about cancers associated with breast implants
Read full article: FDA warns about cancers associated with breast implantsGetting breast implants can be cosmetic or a medical necessity for reconstruction. The decision to have either procedure done will hopefully only improve life, not hurt someone’s health.
FDA says 3 negative rapid tests needed for asymptomatic COVID-19 cases
Read full article: FDA says 3 negative rapid tests needed for asymptomatic COVID-19 casesThe Food and Drug Administration now recommends that people who have been exposed to the coronavirus should have three negative at-home tests, even if they don’t have symptoms.
FDA recommends people perform repeat or serial testing when taking at-home COVID-19 tests to reduce risk of false negative results
Read full article: FDA recommends people perform repeat or serial testing when taking at-home COVID-19 tests to reduce risk of false negative resultsThe FDA says if repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms.
New text messaging system ‘This is Quitting’ helps teens put an end to vaping
Read full article: New text messaging system ‘This is Quitting’ helps teens put an end to vapingFollowing the FDA’s ban on Juul, a nonprofit hopes that more teens quit their addiction to vaping with a help of a simple text message.
Judge Lina Hidalgo announces Harris County Public Health will start distributing vaccine for kids under 5
Read full article: Judge Lina Hidalgo announces Harris County Public Health will start distributing vaccine for kids under 5Judge Hidalgo provided an update Thursday on Harris County’s distribution of the recent FDA-authorized pediatric vaccines with Texas Children’s Hospital and Harris County Public Health Department.
FDA to investigate delay in baby formula plant inspection, commissioner says
Read full article: FDA to investigate delay in baby formula plant inspection, commissioner saysFood and Drug Administration Commissioner Robert Califf said Monday that the agency will investigate why it took so long to dispatch inspectors to the Abbott Nutrition baby formula plant in Michigan.
Parents in the Houston area split on Moderna’s COVID-19 vaccine for children under 6
Read full article: Parents in the Houston area split on Moderna’s COVID-19 vaccine for children under 6Moderna is now seeking emergency use authorization from the FDA for its COVID-19 vaccine for children under 6 years old.
More Similac baby formula recalled after infant death, FDA says
Read full article: More Similac baby formula recalled after infant death, FDA saysThe U.S. Food and Drug Administration said on Monday that Abbott Laboratories recalled some Similac PM 60/40 cans and cases produced at a Michigan facility, after an infant who was exposed to the powdered baby formula died.
Stem cells may help patients with long term COVID symptoms
Read full article: Stem cells may help patients with long term COVID symptomsIf you or someone you know is suffering from the long-term impacts of COVID, you know it’s not easy to find relief. A trial using stem cells to treat long-term COVID symptoms has been so successful, more patients are being added.
News headlines of 2021: How much do you remember? Take this quiz to find out.
Read full article: News headlines of 2021: How much do you remember? Take this quiz to find out.We might not be able to claim that 2021 was *the* wildest year in recent history (2020 will likely get that credit for quite some time), but it might be a close second.
Some Old Spice, Secret aerosol antiperspirants recalled for having cancer-causing ingredient, FDA says
Read full article: Some Old Spice, Secret aerosol antiperspirants recalled for having cancer-causing ingredient, FDA saysA voluntary recall has been issued by the Procter & Gamble Company for some Old Spice and Secret aerosol spray antiperspirants for having the presence of benzene, according to the FDA.
Wondering who can get a COVID-19 vaccine booster shot and when? Here’s what Texans need to know.
Read full article: Wondering who can get a COVID-19 vaccine booster shot and when? Here’s what Texans need to know.The vaccine’s protection goes down with time, so medical experts recommend a supplemental dose after two to six months. Find out here if it’s time to get one.
Memorial Hermann offering booster shots for immunocompromised
Read full article: Memorial Hermann offering booster shots for immunocompromisedMemorial Hermann announced that it will offer booster shots of the Pfizer and Moderna vaccine in hospitals and clinics throughout the Greater Houston area to immunocompromised people who meet criteria set by the Centers for Disease Control and Prevention.
Medical experts discuss risks of people self-prescribing COVID-19 booster shots
Read full article: Medical experts discuss risks of people self-prescribing COVID-19 booster shotsAs the Delta variant continues to spread some people are nervous hoping a third shot or booster shot will give them more immunity and they are getting it deceptively.
FDA letter calls out Amazon for products with harmful ingredients
Read full article: FDA letter calls out Amazon for products with harmful ingredientsThe U.S. Food and Drug Administration (FDA) has warned Amazon of 30 sexual enhancement and weight loss supplements sold on its website that contained “undeclared and potentially harmful drug ingredients,” according to a letter sent to the company.
Nurse expresses concerns about Houston Methodist’s mandatory vaccine policy for employees
Read full article: Nurse expresses concerns about Houston Methodist’s mandatory vaccine policy for employeesA nurse of more than six years at Houston Methodist Baytown, who doesn’t want to be identified, said she is not okay with the hospital’s policy of requiring all employees to be vaccinated for COVID-19.
US health officials call for ‘pause’ in use of Johnson & Johnson vaccine over clot reports
Read full article: US health officials call for ‘pause’ in use of Johnson & Johnson vaccine over clot reportsThe U.S. recommendation to “pause” use of the single-dose Johnson & Johnson COVID-19 vaccine set off a chain reaction worldwide and dealt a setback to the global vaccine campaign.
Sugar Land biopharmaceutical company gets FDA approval to treat COVID-19 long haulers with adult stem cells
Read full article: Sugar Land biopharmaceutical company gets FDA approval to treat COVID-19 long haulers with adult stem cellsSUGAR LAND, Texas – A Sugar Land biopharmaceutical company is the first in the nation to receive FDA approval or a trial to treat COVID-19 long haulers with adult stem cells. Long haulers are patients who are no longer infected with coronavirus but suffer the harsh symptoms sometimes for months after. “We just don’t know how well they work in COVID long haulers. Hope Biosciences then uses a patented media, or food source, that eventually grows one billion of the patient’s stem cells that will be injected back into their body. “I think that’s what these COVD-19 long haulers want,” Chang said.
Houston-based company receives FDA for use of Rapid Acoustic Pulse technology to reduce cellulite appearance
Read full article: Houston-based company receives FDA for use of Rapid Acoustic Pulse technology to reduce cellulite appearanceHOUSTON – Soliton, a Houston-based company, has been granted approval by the U.S. Food and Drug Administration (FDA) for its technology that can purportedly blast away cellulite. According to a news release from the company, its new Rapid Acoustic Pulse (RAP) technology works with soundwaves to reduce the appearance of cellulite. “We’re thrilled to receive this latest clearance for our RAP technology,” Soliton president and CEO Brad Hauser said. AdThe new innovation derives from Soliton’s tattoo removal device that treats the skin with up to 100 waves per second. The company first received FDA approval for using RAP technology for tattoo removal in 2019, according to the release.
J&J’s 1-dose shot cleared, giving US 3rd COVID-19 vaccine
Read full article: J&J’s 1-dose shot cleared, giving US 3rd COVID-19 vaccineThe FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache. All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that coats it. It’s the same technology the company used in making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.
Eli Lilly’s antibody combination receives FDA emergency use authorization to treat COVID-19 patients
Read full article: Eli Lilly’s antibody combination receives FDA emergency use authorization to treat COVID-19 patientsFILE - This is an April 26, 2017, file photo showing Eli Lilly corporate headquarters in Indianapolis. Eli Lilly continues to back a potential COVID-19 treatment despite research showing that it may not work on hospitalized patients. The drugmaker said Tuesday, Oct. 27, 2020, that It remains confident that its drug may stop COVID from developing in other patients. (AP Photo/Darron Cummings, File)HOUSTON – Eli Lilly’s announced Tuesday the approval by the U.S. Food and Drug Administration (FDA) of Emergency Use Authorization (EUA) for its combination antibody therapy. Lilly will collaborate with the bio-tech company Amgen to manufacture up to one million doses of etesevimab for administration with bamlanivimab by mid-2021.
Johnson & Johnson asks FDA to approve its one-shot coronavirus vaccine
Read full article: Johnson & Johnson asks FDA to approve its one-shot coronavirus vaccineJohnson & Johnson asked U.S. regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. J&J’s vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study. OTHER OPTIONSIn large U.S. studies, two doses of the Pfizer and Moderna vaccines proved 95% protective against any symptomatic COVID-19. J&J also is studying a two-dose version of its vaccine, but results won’t be available for several more months. THE SUPPLYJ&J said it would have some vaccine ready to ship if the FDA allows emergency use of the shot, but it didn’t reveal how much.
Recall on brand of pet food expanded after more than 2 dozen dogs die, FDA says
Read full article: Recall on brand of pet food expanded after more than 2 dozen dogs die, FDA saysA pet food recall has expanded after the Food and Drug Administration announced that more than two dozen dogs died after eating Sportmix brand dry kibble. The list of recalled dry pet food products announced by Midwestern Pet Foods, Inc. on December 30, 2020 is:Sportmix Energy Plus, 50 lb. bag Exp 03/02/22/05/L2 Exp 03/02/22/05/L3 Exp 03/03/22/05/L2Sportmix Energy Plus, 44 lb. bagSportmix High Energy, 44 lb. bagSportmix High Energy, 50 lb.
FDA warning over false-negative results with Curative’s COVID-19 test
Read full article: FDA warning over false-negative results with Curative’s COVID-19 testHOUSTON – The Food and Drug Administration is warning about the risk of false results, specifically false negatives, with Curative’s COVID-19 test. The agency posted an alert to patients and healthcare providers on its website on Monday. According to Curative’s website, the test involves coughing three to five times and then swabbing the inside of your mouth. The FDA said the test needs to be done properly, under the watch of a trained healthcare worker, to reduce the risk of the wrong result. The FDA’s post said healthcare providers should consider retesting patients with a different test if they suspect the result was not accurate and the result was given recently.
FDA authorizes emergency use of Moderna’s coronavirus vaccine
Read full article: FDA authorizes emergency use of Moderna’s coronavirus vaccineThe U.S. is poised to give the green light as early as Friday, Dec. 18, to a second COVID-19 vaccine, a critical new weapon against the surging coronavirus. The move marks the world’s first authorization for Moderna’s shots. FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine, the first-ever regulatory clearance for the small Cambridge, Massachusetts, company. Injections of health workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to get in line. But there was a hint that Moderna’s shot might provide some protection against asymptomatic infection.
Differences between Pfizer and Moderna vaccines
Read full article: Differences between Pfizer and Moderna vaccinesHOUSTON – Earlier this week we watched as the Pfizer vaccinations began locally and nationally and the FDA said both vaccines are almost equal at being effective. Pfizer administered 21 days apart, Moderna will be 28 days. Pfizer can only thaw to refrigerated temps for five days before it expires. However, Kroger said their pharmacies are actually planning to get the Pfizer vaccine next week. “They’re over 900 vaccines per case, they can stay in that case for over two weeks.
Moderna vaccine is life-line to rural Texas healthcare providers
Read full article: Moderna vaccine is life-line to rural Texas healthcare providersHOUSTON – Officials with the Texas Department of State Health Services anticipate receiving 460,000 vials of the Moderna vaccine next week and plan to use this vaccine to cover rural areas and smaller healthcare providers. “Most of rural Texas is at capacity and can’t expand, and it’s not as much about space as it is staff and equipment. They just don’t have that capacity.”Henderson agrees the Moderna vaccine is a perfect fit for rural Texas. This vaccine doesn’t have to be stored at ultra-cold temperatures like the Pfizer vaccine. The full FDA will make a decision by the weekend as to whether it will allow the Moderna vaccine to be used.
Panel votes to recommend approval of Moderna’s coronavirus vaccine to FDA
Read full article: Panel votes to recommend approval of Moderna’s coronavirus vaccine to FDAModerna’s shot showed similarly strong effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people. Moderna’s vaccine uses the same groundbreaking technology as Pfizer-BioNTech’s shot. Both require two doses; Moderna's is four weeks apart. After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine.
Local infectious disease doctor explains similarities between Pfizer, Moderna vaccines
Read full article: Local infectious disease doctor explains similarities between Pfizer, Moderna vaccinesA local expert explained the differences between the Moderna vaccine and the one approved last week from Pfizer. “I would have no qualms with receiving either vaccine,” said Dr. Jennifer Whiatker, an infectious disease specialist with Baylor College of Medicine. But the Moderna vaccine is recommended for patients 18 and older while Pfizer’s vaccine can be administered to patients as young as 16. “It might be a little bit easier to distribute the Moderna vaccine,” Whitaker said. Dr. Anthony Fauci, the nation’s top infectious disease doctor, says if the FDA advisory committee recommends the Moderna vaccine tomorrow afternoon it actually could be approved by the FDA as early as tomorrow evening.
‘Relieved’: US health workers start getting COVID-19 vaccine
Read full article: ‘Relieved’: US health workers start getting COVID-19 vaccine“Relieved,” proclaimed critical care nurse Sandra Lindsay after becoming one of the first to be inoculated at Long Island Jewish Medical Center in New York. “I feel like healing is coming.”With a countdown of “3-2-1,” workers at Ohio State University's Wexner Medical Center gave initial injections to applause. It just represents a moral failing,” said Jennifer Nuzzo, a public health researcher at Johns Hopkins. Getting vaccinated is “a privilege,” said Dr. Leonardo Seoane, chief academic officer at Ochsner Health in suburban New Orleans, after getting his dose. And later this week, the FDA will decide whether to green-light the world’s second rigorously studied COVID-19 vaccine, made by Moderna Inc.
US allows emergency COVID-19 vaccine in bid to end pandemic
Read full article: US allows emergency COVID-19 vaccine in bid to end pandemicWASHINGTON – The U.S. Department of Health and Human Services and the Department of Defense held a briefing with Operation Warp Speed on the COVID-19 vaccine distribution. View the briefing below:The Food and Drug Administration held a briefing Saturday following its authorization of Pfizer’s Covid-19 vaccine for emergency use Friday. View the briefing in its entirety below:The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans. The U.S. is considering a second vaccine, made by Moderna Inc., that could roll out in another week. In addition, the FDA insisted that large COVID-19 vaccine studies track at least half the participants for two months to look for side effects, a time period when historically any vaccine problems appear.
Thousands of Texas healthcare providers enrolled to distribute COVID-19 vaccine
Read full article: Thousands of Texas healthcare providers enrolled to distribute COVID-19 vaccineHOUSTON – State health officials said more than 5,000 healthcare providers have enrolled with the Texas Department of State Health Services to distribute the COVID-19 vaccine. Texas’ Expert Vaccine Allocation Panel is working on who will be among the next to receive the vaccine. Only documented healthcare providers who’ve enrolled with the state can receive the vaccine. Healthcare providers also had to prove they could store the Pfizer vaccine at sub-zero temperatures. Texas’ first-week allotment schedule shows the nearly 225,000 doses will be sent to 109 healthcare providers in 34 counties.
FDA advisory panel recommends approval of Pfizer coronavirus vaccine
Read full article: FDA advisory panel recommends approval of Pfizer coronavirus vaccinePfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. FDA scientists issued a glowing review of the vaccine earlier in the week. The company proposed gradually moving those patients to the vaccine group, with priority based on age, health conditions and other factors. Pfizer must still show whether the vaccine works in children younger than 16 and in pregnant women.
FDA panel meets Thursday to debate future of Pfizer’s coronavirus vaccine in US
Read full article: FDA panel meets Thursday to debate future of Pfizer’s coronavirus vaccine in USA final FDA decision and the first shots could follow within just days. FDA scientists reanalyzed data from Pfizer's huge, still-unfinished study and found that so far, the vaccine appears safe and more than 90% effective across patients of different ages, races and underlying health conditions. The FDA specifically confirmed it works well in older people, who are especially vulnerable to the virus. Moderna has reported nearly identical protection in tests of its vaccine, which was developed with the U.S. National Institutes of Health. --Does the vaccine protect against infection with no symptoms, or could the vaccinated still unknowingly spread the virus?
What possible adverse reactions to Pfizer vaccine could mean for Americans
Read full article: What possible adverse reactions to Pfizer vaccine could mean for AmericansHOUSTON – Two people who experienced possible allergic reactions after receiving the Pfizer vaccine in the UK are recovering well, according to UK regulators. However, now there’s a warning for those who have a history of severe allergic reactions, such as those to food, medicine, vaccines or need to carry an epi-pen. “There are people who have had true allergic reactions to vaccines in the past. “Work out a strategy about when and how they can safely receive the vaccine,” McCarthy said. “It may mean they need to receive it in a more monitored environment.”Locally, researchers said they’ve witnessed zero allergic reactions to the vaccines in clinical trials.
Houston hospitals finalizing distribution plans for Pfizer’s COVID-19 vaccine
Read full article: Houston hospitals finalizing distribution plans for Pfizer’s COVID-19 vaccineHOUSTON – More than 220,000 vaccines are expected across the state next week beginning as early as Monday. Here in Houston, many hospitals are looking to vaccinate or than 1,000 healthcare workers per day. Houston area hospital plans for Pfizer’s COVID-19 vaccine distribution are being finalized as healthcare workers wait for FDA emergency approval. About 2,000 healthcare workers are expected to be vaccinated per day. Again vaccine distribution could start as early as next week.
Texas working to finalize COVID-19 vaccination distribution plans
Read full article: Texas working to finalize COVID-19 vaccination distribution plansVan Deusen said the state estimates there are 1.6 million healthcare workers. “So that’s the allocation for December, it will be weekly, on-going,” said Van Deusen. Van Deusen said test runs are already being done to make sure the shipping process is working properly. Van Deusen said while the Moderna vaccine also has to be shipped frozen. “The Moderna vaccine gives us a lot more flexibility in terms of where we can send it in the state,” said Van Deusen.
Houston Methodist Hospital has three infusion sites for COVID antibody treatment
Read full article: Houston Methodist Hospital has three infusion sites for COVID antibody treatmentHOUSTON – The Houston Methodist Hospital is now administering the FDA emergency use authorization drug, bamlanivimab. There are three sites where the hospital offers monoclonal antibody infusions: Houston Methodist Hospital at the Texas Medical Center, Houston Methodist Sugar Land and Houston Methodist Continuing Care Facility near the West campus in Katy. Since the hospital system started this therapy on Friday, they said 50 patients have been treated. Sandy Zeluff said she was one of the first patients to receive this treatment. After her symptoms were getting progressively worse last week, she says she made a recovery within a day of infusion.
FDA allows emergency use of antibody drug Trump received
Read full article: FDA allows emergency use of antibody drug Trump receivedEmergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied. There's no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own. FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.
The Latest: S Korea begins stronger limits in some areas
Read full article: The Latest: S Korea begins stronger limits in some areasIn 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. — Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the state’s 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.
Local experts explain how Houstonians could benefit from Pfizer vaccine
Read full article: Local experts explain how Houstonians could benefit from Pfizer vaccine“This is one of the most significant medical advances in the last 100 years,” Dr. Albert Bourla, Pfizer Chairman and CEO, said. El Sahly actually oversees the Moderna trial for Baylor College of Medicine. Americans will receive the vaccine for free consistent with the U.S. government’s commitment for free access for COVID-19 vaccines." Some infectious disease experts, including Dr. Peter Hotez with Baylor College of Medicine, believe the first vaccine available may not be the one that’s proven most effective in the long run. “I’m often asked the question, ‘hey Dr. Hotez which vaccine are you waiting for?’ That’s the wrong question I’m not waiting for anything,” Hotez explained.
Warning for parents about children overdosing in ‘Benadryl challenge'
Read full article: Warning for parents about children overdosing in ‘Benadryl challenge'Some teens and children are intentionally overdosing on the antihistamine, Benadryl, as part of a “challenge” on Tik Tok. While the social media platform has pledged to remove videos publicizing it, local doctors and the Food and Drug Administration are warning parents about ways to recognize if your child is doing this. We are aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok. BENADRYL® products and other diphenhydramine products should only be used as directed by the label. The most common way people overdoseOne toxicologist said Benadryl is the most common over-the-counter drug to overdose on.
Don’t drink that! FDA issues warning on hand sanitizer packaged in food, drink containers
Read full article: Don’t drink that! FDA issues warning on hand sanitizer packaged in food, drink containersHOUSTON – Since the start of the coronavirus pandemic, many companies switched to making much-needed products like PPE and hand sanitizer. Because they already had the containers on-hand, many of the companies that switched to making alcohol-based hand sanitizers have been packing it in containers meant for food or drink. “It’s dangerous to add scents with food flavors to hand sanitizers, which children could think smells like food, eat and get alcohol poisoning,” said Hahn. For more information, people can read the FDA’s guidelines on safe use of hand sanitizer or check out the agency’s question and answer page. People can also go online to see a list of hand sanitizers the FDA says people should not use.
SAVE THIS: Emergency information you need if you have a chronic condition, need medication
Read full article: SAVE THIS: Emergency information you need if you have a chronic condition, need medicationThey will be giving you important information specific to your condition and let you know where to go for treatment if your facility closes. DIALYSIS PATIENTS NEED TO SAVE THIS INFORMATIONPatients may have questions like: What to do if a dialysis facility closes? For help, the Kidney Community Emergency Response (KCER) is available by phone 24/7 to answer your questions regarding kidney conditions and emergency events. Under emergency conditions, you still may need to use the insulin that has been stored above 86°F. For more information see Information Regarding Insulin Storage and Switching Between Products in an Emergency (en Español).
Doctors discuss blood plasma treatment for COVD-19 as FDA puts authorization on hold
Read full article: Doctors discuss blood plasma treatment for COVD-19 as FDA puts authorization on holdHouston Methodist Hospital is one such site conducting clinical trials and doctors there say recent results have shown promise. If you look at 28 days post-transfusion of the plasma, there is a significant reduction in mortality and death in those patients who received the plasma, Musser said. Despite the optimistic results from trials across the country, the Emergency Use Authorization of blood plasma as a treatment by the FDA is on hold, according to a New York Times article. It just means at this point the FDA wants additional information, said Dr. Musser. Although the Emergency Use Authorization is on hold for now, that is not to say things couldnt change after more data is collected.
New COVID-19 antibody testing available at Toyota Center
Read full article: New COVID-19 antibody testing available at Toyota CenterHOUSTON – A new COVID-19 antibody testing is available in Houston, which has proven to be highly accurate in determining the existence of coronavirus antibodies in a person’s system. Genalyte, a California-based diagnostics company, is offering its SARS-CoV-2 Multi-Antigen Serology Panel at the Toyota Center at 1510 Polk St.Genalyte will begin accepting appointments on Wednesday. Genalyte completed the LDT certification for its SARS-CoV-2 Serology Panel and is completely compliant with all regulations. Genalyte’s U.S. Food and Drug Administration (FDA)-cleared Maverick™ Diagnostic System will expand antibody testing in the fight against COVID-19 with the launch of its SARS-CoV-2 Multi-Antigen Serology Panel. The Genalyte serology test also has a very low false-positive rate—with accuracy exceeding 99 percent, according to Gunn.
COVID-19 at-home test: What you need to know about the Kroger test just approved by the FDA
Read full article: COVID-19 at-home test: What you need to know about the Kroger test just approved by the FDAHOUSTON The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization for the Kroger brands COVID-19 Test Home Collection Kit, the grocery chain announced Wednesday. Heres how Kroger Healths COVID-19 Test Home Collection Kit works, as described by the company:The home collection is performed under the supervision of a licensed healthcare professional. Upon receipt of the home collection kit, a healthcare professional guides the home collection process via telehealth a two-way video chat. The direct observation helps to ensure the proper technique is used for sample collection. If test results are negative for an active infection, results are released to the patients electronic medical record portal.
These 9 hand sanitizers produced by Eskbiochem may contain a potentially fatal ingredient, FDA warns
Read full article: These 9 hand sanitizers produced by Eskbiochem may contain a potentially fatal ingredient, FDA warnsThe US Food and Drug Administration is advising consumers not to use hand sanitizer products manufactured by Eskbiochem SA due to the potential presence of a toxic chemical. The FDA has discovered methanol, a substance that can be toxic when absorbed through skin or ingested, in samples of Lavar Gel and CleanCare No Germ hand sanitizers, both produced by the Mexican company. The FDA recommends that consumers avoid the following brands of hand sanitizers produced by Eskbiochem:All-Clean Hand Sanitizer (NDC: 74589-002-01)Esk Biochem Hand Sanitizer (NDC: 74589-007-01)CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)Exposure to significant amounts of methanol can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Anyone exposed to these hand sanitizers should seek immediate treatment, the FDA warns. The FDA asked Eskbiochem SA to remove its hand sanitizer products from shelves on June 17 but has yet to receive a response from the company.
FDA warns against Mexican-made sanitizer gel containing methanol
Read full article: FDA warns against Mexican-made sanitizer gel containing methanolMEXICO CITY The U.S. Food and Drug Administration has issued a warning about a Mexican-made hand sanitizer gel that it said is dangerous because it contains large amounts of poisonous methanol, or wood alcohol. The FDA said the methanol can be toxic when absorbed through the skin or ingested, and recommended consumers dispose of nine brands of gel sanitizers made by Eskbiochem SA de CV. The FDA said one of the brands contained 81% methanol and no ethyl alcohol, which is the drinkable kind. The brands include All-Clean Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer, The Good Gel Antibacterial Gel Hand Sanitizer and CleanCare NoGerm Advanced Hand Sanitizer. Methanol is a poisonous cousin of the ethyl alcohol in normal liquors and cannot be smelled or tasted in drinks.
US stuck with stockpile of 63M doses of hydroxychloroquine after FDA revokes emergency use authorization
Read full article: US stuck with stockpile of 63M doses of hydroxychloroquine after FDA revokes emergency use authorization(CNN) – The federal government is stuck with 63 million doses of hydroxychloroquine now that the US Food and Drug Administration has revoked permission for the drug to be distributed to treat coronavirus patients. The government started stockpiling donated hydroxychloroquine in late March, after President Trump touted it as "very encouraging" and "very powerful" and a "game-changer." That leaves the Strategic National Stockpile with 63 million doses of hydroxychloroquine, plus another 2 million doses of chloroquine, a related drug donated by Bayer, according to Carol Danko, a spokesperson for the US Department of Health and Human Services. Before the FDA revoked its authorization, the stockpile had already distributed 31 million doses. Novartis and Mylan donated doses of the drug to the stockpile.
Humans can infect their pets with coronavirus, FDA says
Read full article: Humans can infect their pets with coronavirus, FDA saysThe Food and Drug Administration posted a video Friday that says pets likely cant spread the coronavirus, but they can get it from people. Limited information from the Centers for Disease Control and Prevention indicates while humans can infect their pets, the transmission risk seems to be low. The FDA suggests following these tips when caring for a pet during the pandemic:Make sure pets are leashed when outside and practice social distancing when walking. If you are unable to find pet care, you should wear a face covering when around your pet. To learn more and to find other FAQs about coronavirus and pets, click here.
Local doctors have opposing take on using hydroxychloroquine to treat COVID-19 patients
Read full article: Local doctors have opposing take on using hydroxychloroquine to treat COVID-19 patientsHOUSTON – The Food and Drug Administration has revoked its emergency use authorization for hydroxychloroquine as a treatment for the coronavirus. At Houston’s United Memorial Medical Center, dozens of COVID-19 patients have taken the drug, according to Dr. Joseph Varon, chief medical officer. “Hydroxychloroquine works,” Dr. Varon said. Dr. Varon believes the treatment is effective, as long as it’s given early to patients and they’re closely monitored in the hospital. By day four or day five, they really do better,” said Dr. Varon.
Sweet Tomatoes closing for good amid coronavirus pandemic, report says
Read full article: Sweet Tomatoes closing for good amid coronavirus pandemic, report saysSweet 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. WKMG reported the self-service eatery will close all 97 restaurants, it announced Thursday. 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. “The regulations are understandable, but unfortunately, it makes it very difficult to reopen. 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?
Read full article: 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, it’s then tested on tens of thousands of people to make sure there are few adverse side effects and the vaccine is effective.
Houston Methodist first in the nation to be approved by FDA to transfuse donated plasma from recovered COVID-19 patient
Read full article: Houston Methodist first in the nation to be approved by FDA to transfuse donated plasma from recovered COVID-19 patientHOUSTON – Houston Methodist Hospital will be the first academic medical center in the country to transfuse donated plasma from a recovered COVID-19 patient to a critically-ill COVID-19 patient. "What we did is transfused COVID-19 convalescent plasma to two critically ill patients," said Dr. Eric Salazar, the principal investigator and a physician-scientist at Houston Methodist. Houston Methodist Hospital said the FDA must approve each patient using the donated convalescent serum. Houston Methodist said physicians began recruiting blood plasma donors on Friday from approximately 250 patients who have tested positive for the COVID-19 virus at Houston Methodist hospitals. "This is like a regular plasma donation, and so we the donors have to qualify to be regular plasma donors.