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The maker of a drug used to treat ADHD and narcolepsy has recalled one lot of the medication after a pill mixup was discovered. The recall notice, issued by Azurity Pharmaceuticals Inc., states that one lot of Zenzedi 30-milligram tablets is being recalled after a pharmacist found antihistamine tablets in a bottle labeled as Zenzedi. The active compound in Zenzedi is dextroamphetamine sulfate, a stimulant used for the treatment of narcolepsy and ADHD. Meanwhile, the allergy drug found in the mislabeled bottles contains the sedative carbinoxamine, which has the opposite effect of a stimulant. The recall comes amid an ongoing national shortage of ADHD drugs, creating further frustration for people with ADHD who have struggled to find medications for their condition, CNN reported. The recall notice said that people who take carbinoxamine instead of Zenzedi have a higher risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder. The recalled lot has the lot number F230169A and an expiration date of June 2025. Azurity added that it has not received any reports of serious injury related to the medication mixup. Consumers who have the recalled medication should return it to their pharmacy and call their doctor if they have any bad reactions to the drug. Problems may also be reported to the FDA’s MedWatch Adverse Event Reporting program. More information Drugs.com has… read on > read on >

Following a recall of millions of its breathing machines that began in mid-2021, Philips Respironics announced Monday that it would halt sales of all such machines within the United States. The machines include continuous positive airway pressure (CPAP) devices used by people with sleep apnea, as well as ventilators used by other patients. The recall was first spurred in 2021 by reports of defective CPAP machines emitting bits of foam and potentially toxic gases back into users’ airways. At the time, Philips initiated a recall of the devices in June 2021 and put a pause on sales of new sleep therapy machines to U.S. customers, Philips spokesman Steve Klink told the New York Times. After that, Philips published data from follow-up testing that it said showed the devices were “not expected to result in appreciable harm to health in patients,” although further testing was ongoing. However, the U.S.Food and Drug Administration questioned the validity of those claims, calling them “unpersuasive,” the Times said. Although the 2021 recall affected about 15 million devices manufactured since 2006, over 5 million more were thought to be still in use by 2021, the Times said. Many thousands of U.S. patients and their families who used the breathing machines have sued Philips, blaming the faulty devices for a wide range of ailments, including fatal lung cancers. According to the Times, in… read on > read on >

It’s not easy to lose weight, especially when facing a world filled with the temptation of tasty treats and rich, delicious meals. But being kind to yourself can make the difference when it comes to sticking to a diet, a new study reports. Dieters who practice self-compassion — showing themselves the same care and kindness they’d show loved ones — are better able to get past an overeating setback and stick to their weight-loss goals, researchers reported recently in the journal Appetite. Study participants reported more self-control over their eating and exercise if they gave themselves a break regarding a recent diet lapse, researchers found. The findings suggest that self-compassion can prevent people from becoming demoralized by a setback, said Charlotte Hagerman, an assistant research professor with Drexel University’s Weight, Eating and Lifestyle Science (WELL) Center. “Many people worry that self-compassion will cause complacency and lead them to settle for inadequacy, but this study is a great example of how self-compassion can help people be more successful in meeting their goals,” Hagerman said in a Drexel news release. “The road to achieving difficult goals — especially weight loss — is paved with setbacks,” Hagerman added. “Practicing self-compassion helps people cope with self-defeating thoughts and feelings in response to setbacks, so that they are less debilitated by them. In turn, they can more quickly resume pursuing… read on > read on >

THURSDAY, Jan . 25, 2024The maker of Robitussin has recalled eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult cough syrups. The products, which are made by Haleon, may be contaminated with a microbe, and “in immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection,” the recall notice said. Fungemia is a fungal infection of the blood. In people with healthy immune systems, infection is unlikely to lead to severe illness, “however, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out,” the company said. Haleon says that no illnesses in customers using the product have yet been reported. The recall only pertains to eight specific lots, which are listed in the full company announcement posted by the FDA. Customers who know they have purchased one of the recalled products should not use them, and they should reach out to Haleon at 1-800-245-1040 (Monday through Friday 8 a.m. to 6 p.m. Eastern Time) or via email to mystory.us@haleon.com. SOURCE: Haleon, recall notice, Jan. 24, 2024 What This Means for You: The maker of Robitussin is recalling eight lots of Robitussin Honey CF products due to microbial contamination that could cause fungal disease read on >

WEDNESDAY, Jan. 24, 2024 (Healthday News) — The U.S. Food and Drug Administration has told drugmakers to add a boxed warning to a type of cancer treatment called CAR-T therapy, saying the treatment itself may sometimes cause a secondary cancer. Still, FDA spokesperson Carly Kempler told NBC News that, despite the new warning, “the overall benefits of these products continue to outweigh their potential risks.” Twenty-five reports of rare blood cancers in patients who had gotten CAR-T therapy prompted the agency to add the boxed warning, Kempler said. CAR-T therapy uses a patient’s own immune cells to fight blood cancers such as leukemia, multiple myeloma and lymphoma. Immune cells are harvested from the patient and then genetically altered in a lab to make them target cancer cells. Once tweaked, the immune cells are infused back into the patient. It’s a powerful therapy: In 2022, doctors who had treated two leukemia patients with CAR-T a decade ago reported that the treatment had essentially cured the patients. “This has been a game changer when we think about treating lymphoma and other diseases,” Dr. Matthew Frigault, clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program, told NBC News. In 2017, the first CAR-T therapy, Novartis’ drug Kymriah, was approved by the FDA. Another five therapies have since been approved. The makers of five of these drugs — Bristol Myers Squibb, for Abecma… read on > read on >

A daily multivitamin could help people keep their brains healthy as they age, a new trial finds. Results suggest taking multivitamins could help prevent memory loss and slow cognitive aging among older adults, researchers report in the Jan. 18 issue of the American Journal of Clinical Nutrition. The effect was measurable: A daily multivitamin slowed brain aging by the equivalent of two years compared to placebo. Still, experts expressed some skepticism, and wondered if simply eating healthy might not bring about the same results. “Taking a multivitamin supplement is probably good for you, but we don’t know if it’s likely to have a big impact in people who have a healthy diet,” Dr. Richard Caselli, a professor emeritus of neurology at the Mayo Clinic in Arizona, told NBC News. “I still maintain a bit of skepticism as far as what magnitude of impact this makes,” he added. “I’m doubtful the difference would be really big.” The new study was led by Dr. Chirag Vyas, an instructor in investigation at Massachusetts General Hospital’s Department of Psychiatry. “Cognitive decline is among the top health concerns for most older adults, and a daily supplement of multivitamins has the potential as an appealing and accessible approach to slow cognitive aging,” he said. The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is a large-scale, randomized trial performed in collaboration by… read on > read on >

Women who consume more plant-based protein tend to age more gracefully, a new study reports. Women with diets rich in protein — especially from plant-based sources — develop fewer chronic diseases and enjoy healthier aging overall, researchers report in the Jan. 17 issue of the American Journal of Clinical Nutrition. Overall, women who ate more plant-based protein were 46% more likely to be healthy into their later years. “Consuming protein in midlife was linked to promoting good health in older adulthood,” said lead researcher Andres Ardisson Korat, a scientist at Tufts University’s Jean Mayer USDA Human Nutrition Research Center on Aging, in Boston. “We also found that the source of protein matters,” Ardisson Korat added in a university news release. “Getting the majority of your protein from plant sources at midlife, plus a small amount of animal protein, seems to be conducive to good health and good survival to older ages.” For the study, researchers analyzed self-reported data from more than 48,000 women participating in the Harvard-based Nurses’ Health Study, which followed female health care professionals from 1984 to 2016. The women entered the study between the ages of 38 and 59, and all were deemed to be in good physical and mental health at the start. The research team evaluated surveys that tracked participants’ diets, and then compared that information to the women’s overall… read on > read on >

Casgevy, a groundbreaking treatment that was approved to treat sickle cell disease in December, was given the U.S. Food and Drug Administration’s blessing on Tuesday to treat another inherited blood disorder. Casgevy is the first CRISPR-based medicine, where gene editing is used to develop the treatment, to be approved for use in the United States. The one-time dose permanently changes DNA in a patient’s blood cells, but experts note the relief will not come cheap. The treatment list price is $2.2 million for its use in both sickle cell disease and beta thalassemia, CNN reported. This latest approval allows Casgevy to be used in patients over the age of 12 with transfusion-dependent beta-thalassemia. With this disorder, the body doesn’t make enough of the oxygen-carrying molecule in blood known as hemoglobin. “Today’s approval is an important step in the advancement of an additional treatment option for individuals with beta-thalassemia, a debilitating disease that places individuals at risk of many serious health problems,” Dr. Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The approval of a cell-based gene therapy for this condition using CRISPR/Cas9 technology reflects FDA’s continued commitment to supporting safe and effective treatments that leverage the most promising and cutting-edge medical technologies,” she added. In December, the FDA approved Casgevy… read on > read on >

Scientists from the U.S. Food and Drug Administration conclude in newly released documents that marijuana has less potential for abuse than other drugs with the same restrictions and it should be reclassified as a less dangerous drug. Not only that, the review found there is some evidence backing its use as a medical treatment. Right now, cannabis is classified as a Schedule I controlled substance, a high-risk category that includes heroin and LSD. The move to reconsider the dangers of marijuana first began in 2022, when President Joe Biden asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra and the attorney general to begin reviewing how marijuana is scheduled under federal law. As part of that process, HHS Assistant Secretary for Health Adm. Rachel Levine wrote a letter to the Drug Enforcement Administration (DEA) in August supporting the reclassification of marijuana to a Schedule III drug, a list that includes ketamine, testosterone and Tylenol with codeine. The FDA documents, which were posted online Friday, state that the agency recommends rescheduling marijuana because it meets three criteria: a lower potential for abuse than other Schedule I and II substances; an accepted medical use; and a low or moderate risk of physical dependence in people who abuse it. The National Institute on Drug Abuse backed the recommendation, the documents state. Although marijuana is widely used for recreational purposes,… read on > read on >

Drugs like Wegovy and Ozempic, which have become a wildly popular way to lose weight or battle diabetes, show no link to suicidal thoughts or actions, the U.S. Food and Drug Administration said Thursday. “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” an FDA review released Thursday stated. Still, the agency noted officials can’t rule out that “a small risk may exist,” and it will continue to look into similar reports involving this class of weight-loss drugs, known as GLP-1 medications. The FDA review comes on the heels of a study funded by the National Institutes of Health that showed people taking semaglutide, the active ingredient in both Ozempic and Wegovy, had a lower risk of suicidal thoughts than those taking other drugs to treat obesity and diabetes. In that study, researchers tracked over 240,000 obese people and more than 1.5 million people with type 2 diabetes. They looked at the risk of suicidal ideation within six months of starting the medicines, as well as at later times. At six months, it found that among people taking the drug for weight loss, semaglutide was linked to a 73% lower risk of first-time suicidal ideation and a 56% lower risk of recurrent suicidal ideation. The drugs that semaglutide was compared to included bupropion, naltrexone, orlistat, topiramate and phentermine.… read on > read on >