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Parts of Intestinal Scope Devices Can Break Off Inside Patients

A medical device used to diagnose and treat pancreatic and bile duct disease is getting attention from the U.S. Food and Drug Administration after pieces have fallen off and remained in patients’ bodies.

Previously, the FDA had expressed

  • Cara Murez HealthDay Reporter
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  • March 24, 2023
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    • Death Count Climbs in Outbreak Linked to Recalled Eyedrops

    WEDNESDAY, March 22, 2023 (HealthDay News) – A drug-resistant bacteria linked to recalled eye drops has now killed three people.

    The U.S. Centers for Disease Control and Prevention reported Tuesday that infections with Pseudomonas aeruginosa had led to two additional deaths.

    In all...

    Gerber Baby Formula Recalled Due to Bacteria Concerns

    Perrigo Co., which makes Gerber Good Start SootheProTM Powdered Infant Formula, has recalled the product over concerns about contamination with a potentially dangerous bacteria.

    Cronobacter sakazakii was possibly present between Jan. 2 and Jan. 18 at the company’s Gateway Eau Claire, Wisc., manufacturing facility.

    No distributed products have tested positive for the bact...

    FDA Advisors Back Full Approval of Paxlovid

    Paxlovid, a medication that has helped millions of high-risk COVID patients avoid hospitalization and death since late 2021, moved one step closer to getting full approval from the U.S. Food and Drug Administration on Thursday.

    An FDA advisory panel voted 16-1 that the Pfizer drug remains a safe and effective treatment and should be given full approval. It has only received emergency use ...

    New Nasal Spray for Migraines Approved by FDA

    MONDAY, March 13, 2023 (HealthDay News) – Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.

    The U.S. Food and Drug Administration has approved Pfizer Inc.’s zavegepant (Zavzpret), a nasal spray meant to treat severe headache pain, the company announced Friday.

    “The FDA approval of Za...

    Mammogram Centers Must Notify Patients of Breast Density, FDA Says

    New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts, a description of how the tissue looks on the X-ray.

    It can be more difficult to detect cancer in dense breast tissue on a mammogram. Having dense breasts is also a risk factor for developing breast cancer.

    The U.S. Food and Drug Administration update amends regulations issued u...

    Preterm Birth Drug Pulled From Market Over Lack of Effectiveness

    Pregnant women will no longer have any drug to prevent preterm birth after the maker of the only available treatment announced Tuesday that it will withdraw its product, Makena, from the market.

    Covis Pharma Group's decision follows a U.S. Food and Drug Administration advisory panel vote last October that concluded the drug does not actually benefit newborns.

    “While we stand by M...

    Two More Brands of Eyedrops Recalled Over Infection Risks

    U.S. Federal health officials have issued recall notices for two more brands of eyedrops.

    In the latest round of recalls, the U.S. Food and Drug Administration posted notices after the companies voluntarily pulled several lots of their eyedrops from the market.

    These recalls do not appear to be connected to other recent recalls or an outbreak in drug-resistant infections, the As...

    FDA Panel to Again Weigh Merit of Decongestant That Many Call Useless

    Consumers have been using a common over-the-counter oral decongestant known as phenylephrine for years, but that may not continue much longer.

    The U.S. Food and Drug Administration has asked a panel of its advisors to reassess the drug’s effectiveness. The medication’s safety isn’t in question, just whether it actually does what it claims to do.

    The FDA’s Nonprescription Dru...

    FDA Panel Backs Second RSV Vaccine for Older Americans

    Following hours of discussion over safety concerns, a U.S. Food and Drug Administration advisory panel on Wednesday recommended approval of a second RSV vaccine, this one made by GlaxoSmithKline, for use in Americans ages 60 and older.

    The panel's recommendation was based largely on the results of a trial that tested the GlaxoSmithKline vaccine in the same age group. Those findings, publi...

    Bed Rails Can Help and Harm: FDA Gives Guidance

    While adult bed rails are marketed with safety in mind, they need to be used with caution, the U.S. Food and Drug Administration advises.

    "Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission]," the FDA said in a new

  • Cara Murez HealthDay Reporter
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  • March 1, 2023
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    • FDA Panel Backs Pfizer's RSV Vaccine for Older Americans

    In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up.

    The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on...

    FDA Takes Action Against Animal Tranquilizer Tied to Fatal ODs

    The U.S. Food and Drug Administration said Tuesday that it has taken action to restrict imports of the veterinary tranquilizer xylazine to prevent illicit use of the drug.

    While veterinarians use products containing xylazine to sedate large animals such as horses and deer, the drug is not safe for people. It is sold on the street under the names tranq, Philly dope and zombie drug.

    F...

    After Criticism, FDA Pledges to Revamp Its Tobacco Division

    The U.S. Food and Drug Administration’s heavily criticized tobacco program promised changes on Friday, including a five-year strategic plan to better outline priorities.

    "As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle," FDA Commissioner Dr. Robert Califf said in an agency news relea...

    Almond, Soy Drinks Can Be Called Milk, FDA Proposes

    THURSDAY, Feb. 23, 2023 (HealthDay News) – Plant-based beverages that use oats, soy, almonds, cashews and other products instead of dairy can continue to call themselves milk.

    The U.S. Food and Drug Administration

  • Cara Murez HealthDay Reporter
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  • February 23, 2023
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    • FDA Panel Says Opioid Overdose Antidote Safe to Sell Over-the-Counter

    A nasal spray that can reverse an opioid overdose should be sold over-the-counter, two expert panels to the U.S. Food and Drug Administration recommended Wednesday.

    Research has shown that wider availability of naloxone -- brand named Narcan -- could save lives as the opioid epidemic rages on in this country.

    The FDA advisors voted unanimously in favor of making the drug easier to ...

    FDA Panel Considers Making Opioid Antidote Drug Available Without Prescription

    A nasal spray that can reverse an opioid overdose may become available for easier over-the-counter purchase.

    U.S. Food and Drug Administration advisers are meeting Wednesday to discuss making generic naloxone hydrochloride available without requiring interaction with a pharmacist, CNN reported.

    Approval could happen later this year. Research shows that wider availability of...

    Could a Vibrating Pill Ease Chronic Constipation?

    A new treatment for chronic constipation may bring relief without having to use drugs.

    It’s a vibrating pill called Vibrant that stimulates the colon as it passes through the body.

    Although the pill was

  • Cara Murez HealthDay Reporter
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  • February 9, 2023
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    • After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety

    Stung by recent food safety scandals -- most notably last year's infant formula shortage, the U.S. Food and Drug Administration announced Tuesday that it is creating a new unit devoted to food safety.

    The newly dubbed Human Foods Program will wield wide-ranging powers.

    "We’re proposing the creation of a unified, newly envisioned organization, called the Human Foods Program, that ...

    FDA Could Ease Blood Donation Rules for Gay Men

    Longstanding restrictions on blood donations from gay or bisexual men could soon shift towards a more nuanced policy, where such men are asked about sexual partners and practices instead, the U.S. Food and Drug Administration announced Friday.

    Specifically, gay men who are in monogamous relationships will no longer be required to abstain from sex for any period of time before donating to ...

    FDA Says No to Regulating CBD Products as Supplements

    The U.S. Food and Drug Administration said Thursday it can't regulate CBD supplements because there isn't enough evidence on their safety. The agency also called on Congress to create new rules for what has become a burgeoning industry.

    "The use of CBD raises various safety concerns, especially with long-term use," FDA Deputy Commissioner

  • Cara Murez and Robin Foster HealthDay Reporters
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  • January 27, 2023
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    • Updated Booster Shots, Not Original COVID Vaccines, Should Be Standard: FDA Panel

    The U.S. Food and Drug Administration's vaccine advisory panel on Thursday voted unanimously to recommend that the agency phase out original versions of COVID vaccines for use in the unvaccinated, in favor of updated bivalent booster shots.

    Committee members also weighed a proposal to streamline the dosing schedule for COVID vaccines by turning them into annual shots that would likely be ...

    Top FDA Official Involved in Baby Formula Debacle Resigns

    A U.S. Food and Drug Administration official who has led the agency’s food policy efforts since 2018 announced his resignation on Wednesday.

    Frank Yiannas was also among the top officials leading the agency response to last year’s infant formula shortage.

    "Today, I informed [FDA] Commissio...

    FDA Wants to Lower Lead Levels in Baby Food

    The U.S. Food and Drug Administration has proposed stricter limits on levels of lead in infant food products.

    The agency announced draft guidance for manufacturers that would lower allowable lead levels in processed foods meant for infants and children 2 years and younger.

    The change could reduce dietary exposure to lead, which can cause neurological and developmental harm, the FDA ...

    U.S. Proposes to Make COVID Shot Annual, Much Like Flu Shot

    The U.S. Food and Drug Administration on Monday asked its vaccine advisory panel to weigh a proposal to turn COVID vaccines into an annual shot for most Americans.

    The committee will weigh the proposal at its Jan. 26 meeting.

    Such a move would simplify future vaccination efforts, a critical point given the fact that efforts to get people to get COVID booster shots have fallen far sh...

    New USDA Rules Ramp Up Oversight of Organic Food

    FRIDAY, Jan. 20, 2023 (HealthDay News) – Organic food will soon have to comply with stricter labeling rules under new requirements announced Thursday by the U.S. Department of Agriculture (USDA).

    In what the Organic Trade Organization (OTA) called the biggest change since the USDA’s organic program was first founded in 1990, the

  • Cara Murez HealthDay Reporter
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  • January 20, 2023
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    • FDA Approves New 2-Drug Combo Medicine for Asthma

    Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.

    The drug is the first approved to combine albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid).

    It's mea...

    FDA Approves Second Alzheimer’s Drug, Despite Safety Concerns

    The U.S. Food and Drug Administration on Friday approved a second Alzheimer's drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

    However, the FDA pointed to the drug's benefits, as well.

    “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Bill...

    Patients, Doctors Await FDA Decision on Experimental Alzheimer’s Drug

    Lecanemab: It's an experimental medication that's been shown in trials to slow cognitive decline in people with Alzheimer’s disease.

    It's also up for accelerated approval by the U.S. Food and Drug Administration, with a decision expected by Jan. 6.

    However, the drug has also been linked to two deaths from brain bleeds among people who’ve used it in trials, so safety concerns c...

    Drug Approved to Help Young Patients Battle a Rare Cancer

    Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact.

    The U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq) for use in p...

    Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer's Drug Aduhelm

    The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.

    Actions the agency took with Biogen, maker of Aduhelm, "raise serious concerns about FDA's lapses in protocol," th...

    Buyer Beware: Bogus Flu Meds Are Out There

    With flu rampant in the United States, the U.S. Food and Drug Administration is warning consumers to be wary of over-the-counter products that promise to cure you of influenza, prevent it or reduce its severity.

    Sellers offering these products may make claims that are not accurate or safe, the FDA cautions.

    "These products can be found online, including popular marketplac...

    Tough New Labeling Law for Sesame Prompts Companies to Add It to Their Products

    Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products.

    The new federal law goes into effect on Jan. 1, adding sesame to the list of major al...

    FDA's Tobacco Unit Overloaded and Lacking Direction, Panel Says

    The U.S. Food and Drug Administration's tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday.

    In addition, the panel blamed the FDA's inconsistent regulation efforts for the spread of unauthorized e-cigarettes that are appealing to teens, among other problems.

    Commissioned by FDA chief

  • Cara Murez HealthDay Reporter
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  • December 20, 2022
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    • FDA Approves Gene Therapy for Tough-to-Treat Bladder Cancer

    Patients with a high-risk bladder cancer now have a new option to treat it.

    The U.S. Food and Drug Administration on Friday approved a gene therapy called Adstiladrin, which is designed to work for patients who have what's called high-risk non-muscle-invasive bladder cancer (NMIBC) that hasn't responded to the standard treatment, Bacillus Calmette-Guérin (BCG), but hasn't spread. BCG is ...

    Cats Now Have an FDA-Approved Pill to Treat Their Diabetes

    Owners whose cats have diabetes now have a new option to care for the condition in their otherwise healthy pets.

    The U.S. Food and Drug Administration on Thursday approved the first pill to improve control of diabetes in some cats.

    The drug, call...

    FDA OKs Bivalent COVID Boosters for Kids 6 Months and Older

    The updated bivalent COVID-19 boosters are now approved for use in children as young as 6 months of age, the U.S. Food and Drug Administration announced today.

    Children can receive either a Moderna or Pfizer-BioNTech bivalent booster shot, although the rules differ depending on their age and what type of vaccine they got as their primary series, the FDA said.

    Kids 6 months to 5 year...

    Lasik Surgery Should Carry Warnings of Possible Complications, FDA Says

    Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications.

    Although many patients are happy with the results after surgery, the recommended new guidance says complica...

    Is a Ban on Menthols Enough to Thwart Big Tobacco?

    A proposed U.S. federal ban on menthol cigarettes doesn't go far enough and needs to include other menthol products, from pipe tobacco to cigarette tubes, researchers say.

    New evidence shows both the appeal and the addiction potential of these substitutes in adults who smoke menthol cigarettes, said scientists from Rutgers University Center for Tobacco Studies in New Brunswick, N.J., and...

    FDA's Food Safety Program Needs a Revamp: Panel

    The U.S. Food and Drug Administration's foods program is in “constant turmoil” and needs stronger leadership, a panel said Thursday.

    The Reagan-Udall Foundation, a group with close ties to the FDA, released a 51-page report Tuesday noting the need for a clear mission in the program ...

    Banning Flavored Vapes Didn't Spur Folks to Quit

    When the U.S. Food and Drug Administration banned fruit-flavored vaping products in early 2020, the idea was to reverse the rapid rise in electronic cigarette use among youths.

    Now, a new survey of adult e-cigarette users finds that instead of quitting e-cigarettes, most vapers switched to flavored products not covered by the ban, or even went back to smoking traditional ciga...

    Pfizer Asks FDA to Approve Tweaked COVID Booster as Third Shot for Kids Under 5

    Infants and young children could soon receive an updated COVID-19 vaccine as part of their three-dose series.

    Pfizer Inc. on Monday asked the U.S. Food and Drug Administration to have the vaccine that targets the Omicron subvariants BA.4 and BA.5 replace the third dose in the series for children aged 6 months through 4 years old. Children in that age group would still receive two doses o...

    First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

    The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections.

    "Today's approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI]," said

  • Cara Murez HealthDay Reporter
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  • December 1, 2022
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    • FDA Moves to Ease Restrictions on Gay Men Giving Blood

    U.S. Food & Drug Administration policies that have limited blood donations from men who have sex with men may soon ease.

    At the moment, FDA policy does not allow blood donation from men who have had sex with other men in the past three months. That's already a shorter timeframe than in the past, when the agency required a one-year gap.

    The agency is now considering switching to ques...

    Berry Good for You: Some Foods Can Strengthen Your Brain

    Eating more berries and drinking tea may help slow mental decline as you age, new research suggests.

    In a study of more than 900 adults, researchers found that foods like these -- containing antioxidant flavonols -- delivered brain benefits to older adults. Flavonols are found in fruits like berries, green leafy vegetables, tea and wine.

    For example, people who ate a serving o...

    A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

    People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag.

    The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost.

    The company said its drug would ultimately reduce health care costs because patients with the genetic disorder would ne...

    FDA Approves First Drug to Delay Onset of Type 1 Diabetes

    The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of type 1 diabetes (T1D).

    Teplizumab (Tzield) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a game changer.

    “Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patient...

    Using an Online Pharmacy to Buy Meds? It's Buyer Beware, FDA Says

    It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns.

    While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit and unsafe medications, the

  • Cara Murez HealthDay Reporter
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  • November 18, 2022
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    • FDA Approves First Lab-Grown Meat Product

    Americans could soon be eating chicken that's grown in a lab from cultured animal cells, rather than raised at a farm or facility.

    The U.S. Food & Drug Administration announced Wednesday that the environment-friendly chicken made by California-ba...

    FDA Moves Toward Making Overdose Antidote an Over-the-Counter Drug

    The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation's opioid epidemic.

    Naloxone (Narcan, Evzio) can save lives when administered soon after the first signs of an overdose from opioids such as heroin, fentanyl, oxycodone or morphine.

    On Tuesday, the FDA

  • Cara Murez HealthDay Reporter
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  • November 16, 2022
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