ALL ABOUT HEALTH -

07Feb 2023 by Janice Holland

FDA Approves First Drug to Delay Onset of Type 1 Diabetes

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For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug that can delay the development of type 1 diabetes.The intravenous drug, teplizumab-mzwv (Tzield), is for adults and children 8 years and older who are at high risk for type 1 diabetes but haven’t yet been diagnosed with the condition and have not yet become reliant on insulin shots. Tzield is in a new family of medicines that slow the immune system’s attack on insulin-producing cells in the pancreas, which is the underlying cause of type 1 diabetes.“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and…

07Feb 2023 by Janice Holland

Experts Debunk Myths About Alternative Medicine for Heart Disease, Heart Failure

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Now more than ever, people are turning to home remedies like herbal medicines, dietary supplements, and homeopathic products, and activities such as yoga, massage therapy, and acupuncture to treat what ails them. The alternative medicine market reached $100 billion in 2021 and projections show that value more than tripling in the next five years, according to a 2022 report from Research and Markets.The use of alternative medicines was a topic of discussion at a panel held on Sunday, November 6 at the AHA Scientific Sessions 2022. Experts addressed myths related to alternative medicines in people with heart disease, such as heart failure. Want to know what the experts think about alternative medicine? Here’s a rundown of what they discussed.Don’t Place Alternative Therapy Above Traditional Medicine“It's critical for us to educate…

06Feb 2023 by Janice Holland

FDA Gives First-Ever Approval for Fecal Transplant Therapy

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The U.S. Food and Drug Administration (FDA) has approved a fecal transplant therapy to prevent recurrence of a bacterial infection that kills up to 30,000 people a year.The therapy, Rebyota, is the first fecal transplant product approved in the United States, the FDA said in a statement. It’s cleared to combat Clostridioides difficile, or C. difficile, a bacteria that can flourish in the gut and cause diarrhea, abdominal pain, and fever, and in rare cases leads to organ failure and death.“Recurrent Clostridioides difficile infection impacts an individual’s quality of life and can also potentially be life-threatening,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, in a statement. The approval of Rebyota “represents an important milestone, as it provides an additional approved option to…

06Feb 2023 by Janice Holland

Blood Pressure Pills Recalled Over Potential Cancer Risk

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Editor’‎s NoteThis story was originally published on Oct. 28, 2022.On Dec. 21, 2022, the FDA announced another distributor, Lupin Pharmaceuticals, was also recalling four lots of the blood pressure medication quinapril for excessive nitrosamines. Source link

06Feb 2023 by Janice Holland

High Blood Pressure Medicine Recalled Again Due to Possible Cancer Risk

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Four lots of the generic high blood pressure medication quinapril tablets have been recalled by its manufacturer, Lupin Pharmaceuticals, because of abnormally high amounts of a probable cancer-causing impurity.Recent testing revealed levels of a nitrosamine impurity (N-nitroso-quinapril) were above the U.S. Food and Drug Administration's (FDA) acceptable daily intake level.While long-term ingestion of this suspected carcinogen may increase cancer risk, there is no immediate danger to patients taking this medication.According to an announcement from the FDA issued on December 21, the quinapril products in question are:20 mg tablets, lot number G102929, expiration date 04/202340 mg tablets, lot number G100533, expiration date 12/202240 mg tablets, lot number G100534, expiration date 12/202240 mg tablets, lot number G203071, expiration date 03/2024The pills were packaged in 90-count bottles and distributed nationwide to wholesalers, drug chains, mail…

06Feb 2023 by Janice Holland

FDA Says Morning-After Pill Isn’t Abortion

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The U.S. Food and Drug Administration (FDA) is changing the packaging information for the emergency contraception pill Plan B to explicitly state a fact that has long been well understood in the medical community: This drug can prevent pregnancy but can’t cause an abortion.Plan B is approved for women to take within 72 hours of sex to prevent pregnancy, and is available over the counter without a prescription or medical exam. The FDA is revising labels inside the package for Plan B to remove a statement unsupported by scientific evidence: that this drug might stop a fertilized egg from implanting in the uterus.Changes to the packaging labels for Plan B clearly distinguish this form of contraception from medication abortion pills, which can stop a pregnancy after a fertilized egg is…

06Feb 2023 by Janice Holland

FDA Approves Briumvi to Treat Relapsing Multiple Sclerosis

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On December 28, 2022, the U.S. Food and Drug Administration (FDA) approved Briumvi (ublituximab), a disease-modifying therapy (DMT) to treat relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS.An estimated one million people in the United States live with MS, with about 25,000 new people diagnosed each year, according to the National MS Society.Briumvi, manufactured by TG Therapeutics, is a glycoengineered monoclonal antibody designed to target B cells — a type of white blood cell — and reduce their numbers. These cells are thought to be one of the immune cells that attacks myelin — the protective coating that insulates nerve cells — in people with MS.Glycoengineered means removing certain sugar molecules normally expressed on the antibody, which is thought to…

06Feb 2023 by Janice Holland

Overconsumption of Common Red Food Dye May Lead to Inflammatory Bowel Disease

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Skittles, Doritos, Gatorade, Jell-O, Fruit Loops, and many other top-selling food products contain a synthetic dye called Allura Red AC that, consumed too frequently, may increase the likelihood of developing inflammatory bowel diseases (IBDs), including Crohn’s disease and ulcerative colitis.A small study involving laboratory mice suggests that frequent and long-term exposure to the dye (also called FD&C Red 40 and Food Red 17) harms gut health and promotes inflammation.Recently published in Nature Communications, the research found that the additive directly disrupts the gut barrier (which helps prevent bacterial intrusion) and increases the production of serotonin, a hormone and neurotransmitter found in the gut. This reaction changes the gut microbiome, leading to increased susceptibility to inflammatory bowel conditions, according to the report.“What we have found is striking and alarming, as this common…

06Feb 2023 by Janice Holland

Some COVID-19 Patients Don’t Recover Their Sense of Smell — Scientists May Know Why

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New research suggests that the presence of ongoing inflammation that damages and destroys cells in the nose may be the reason that some people fail to recover their sense of smell after COVID-19.The study, a collaboration between researchers at Duke, Harvard, and the University of California in San Diego, adds an important insight into a problem that has affected millions of people who have not fully recovered their sense of smell after COVID-19. The findings were published online December 21, 2022, in the journal Science Translational Medicine.Millions Have Not Fully Recovered Their Sense of Smell After COVID-19One symptom long associated with COVID-19 infection is loss of smell, says the senior author of the study, Bradley Goldstein, MD, PhD, associate professor in head and neck surgery and communication sciences and neurobiology at…

05Feb 2023 by Janice Holland

Cluster Headache More Likely to Be Chronic in Women, Study Finds

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Compared with other types of headache, cluster headache is rare. Defined by short but extremely painful episodes that can occur for many days or even weeks in a row, the condition can be excruciating. In fact, the pain can be so unbearable that these attacks have been given the name “suicide headaches.”“Historically, about half the patients who had them would kill themselves [because] the pain was so bad,” says Merle Diamond, MD, the managing director of the Diamond Headache Clinic and the director of the Diamond Inpatient Headache Unit at Saint Joseph Hospital in Chicago. “It’s a knife-searing pain. People have described it as having a hot poker through their eye or somebody stabbing them through their skull.”Although this debilitating condition has been more frequently reported among men, a new…