The U.S. Food and Drug Administration on Thursday approved the nation’s first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans. Women will be able to buy the progestin-only oral contraceptive at drug stores, convenience stores and grocery stores, the FDA said. There is no age limit. Opill, which is made by Perrigo, should be available in stores starting in January or February, the Washington Post reported. The suggested retail price is expected to be announced this fall. Opill was first approved by the FDA in 1973. Other types of birth control pills will remain prescription only. “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news release announcing the approval. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.” The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists (ACOG), and other medical organizations already support over-the-counter access to hormonal contraception without age restrictions. The Free the Pill coalition also has been advocating for over-the-counter status for…  read on >  read on >

A bunch of healthy fruits and vegetables could be just what the doctor ordered. Nonprofit groups and public health agencies have experimented with the idea of a produce prescription over the years. Now, a new study simulates what would happen if patients with diabetes and diet-related conditions were given free or discounted produce and nutrition education nationwide. The researchers, from the Friedman School of Nutrition Science and Policy at Tufts University in Boston, report it could have significant health benefits and save billions of dollars in health care costs. “Of the strategies that can improve American’s nutrition and diet-related health outcomes, evidence continues to build that produce prescriptions are a terrific option,” said senior author Dr. Dariush Mozaffarian, a cardiologist and professor of nutrition, who is also launching an initiative dubbed Food is Medicine. “These innovative treatments are exciting because they can not only improve health and reduce health care spending, but also reduce disparities by reaching those patients who are most in need,” he said in a university news release. The simulation predicted both clinical and financial benefits from making fruits and vegetables more accessible to food-insecure diabetic patients, including a savings of at least $40 billion in medical bills because of nationwide reductions in heart disease. Typically, produce prescription programs allow a patient with a diet-related health condition to get vouchers or electronic…  read on >  read on >

Certain foods are key to reducing heart disease risk, so it’s important to eat them to stay healthy. A globally focused study looked at foods commonly considered to be healthy to better understand this. Consuming fruits, vegetables, legumes, nuts, fish and whole-fat dairy products is key to lowering the risk of cardiovascular disease (CVD), including heart attacks and strokes. The study was led by scientists at McMaster University and the Population Research Health Institute (PHRI) in Hamilton, Ontario, Canada. The investigators noted that there are various ways to achieve a healthy diet — for example, including moderate amounts of whole grains or unprocessed meats. For the study, the researchers analyzed data from multiple studies that included 245,000 people in 80 countries. They derived a diet score from PHRI’s ongoing Prospective Urban and Rural Epidemiological (PURE) study. The team used that to measure health outcomes in different parts of the world and in people with and without prior heart disease. “Previous diet scores — including the EAT-Lancet Planetary Diet and the Mediterranean diet — tested the relationship of diet to CVD and death mainly in Western countries,” senior author Salim Yusuf, principal investigator of PURE, said in a university news release. “The PURE Healthy Diet Score included a good representation of high, middle and low-income countries.” The score focused on exclusively protective, or natural, foods. “We…  read on >  read on >

The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, clearing the way for insurance coverage of the pricey drug. “The full FDA approval will open the floodgates for people with early Alzheimer’s to get this drug. It’s a big deal because it’s very expensive at $26,500 per year,” Robert Vassar, director of Northwestern Medicine’s Mesulam Center for Cognitive Neurology and Alzheimer’s Disease in Chicago, said in a statement released Thursday. “Now, Medicaid and Medicare will cover it as long as patients enroll in a registry to track their progress,” he added. “It’s a big breakthrough because it’s the first disease-modifying drug for Alzheimer’s. This has been the holy grail since the early 1990s when amyloid was discovered, and people were trying to design drugs to eliminate amyloid from the brain,” Vassar explained. “This is the first successful one. There were many attempts in the past that failed. It really shows that removing amyloid does delay the progression of Alzheimer’s disease,” he said. “During the 18-month trial, Leqembi delayed the progression of Alzheimer’s by five months, which is pretty significant,” Vassar noted. Thursdays approval did come with one significant caveat, however: The FDA added a so-called black-box warning to Leqembi’s labeling, cautioning that in rare cases the medication can trigger “serious and life-threatening events,” including brain bleeds, some of…  read on >  read on >

Could swings in your blood fat levels increase your chances of being diagnosed with Alzheimer’s disease? Yes, suggests a new study that found fluctuating cholesterol levels among older adults may increase the risk for Alzheimer’s disease and other dementias. Those who had the most fluctuations in cholesterol had a 19% higher risk of developing Alzheimer’s or dementia, and those with the most fluctuations in triglyceride levels had a 23% increased risk, the researchers found. Still, Dr. Marc Lawrence Gordon, chief of neurology at Northwell Health’s Zucker Hillside Hospital in Great Neck, N.Y., stressed this study can’t prove these variations actually cause Alzheimer’s disease or dementia. “You don’t know whether the fluctuation is what’s driving the incidence of dementia or an increased incidence of dementia is somehow causing fluctuations,” said Gordon, who had no part in the study. “I could not advise any of my patients to do anything in particular on the basis of these data.” However, lead researcher Suzette Bielinski, from the Mayo Clinic in Rochester, Minn., believes the findings could be helpful. “Fluctuations in these results [cholesterol and triglycerides tests] over time could potentially help us identify who is at greater risk for dementia, help us understand mechanisms for the development of dementia, and ultimately determine whether leveling out these fluctuations could play a role in reducing dementia risk,” she said in a…  read on >  read on >

Several companies are selling copycat food items that have the potential to trick people, including children, into consuming dangerous quantities of cannabis. On Wednesday the U.S. Food and Drug Administration and the Federal Trade Commission warned six companies about selling these copycat food products that contain delta-8 tetrahydrocannabinol, also known as delta-8 THC, a substance found in the cannabis sativa plant. The snack foods with delta-8 THC can be mistaken for regular chips, cookies, candies and gummies, according to the FDA. “Children are more vulnerable than adults to the effects of THC, with many who have been sickened and even hospitalized after eating ‘edibles’ containing it. That’s why we’re issuing warnings to several companies selling copycat food products containing delta-8 THC, which can be easily mistaken for popular foods that are appealing to children and can make it easy for a young child to ingest in very high doses without realizing it,” FDA Principal Deputy Commissioner Dr. Janet Woodcock said in an agency news release. The FDA sent warning letters to Delta Munchies, Dr. Smoke LLC (also known as Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC and The Haunted Vapor Room. “The products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos or pictures on packaging, that consumers, especially children, may…  read on >  read on >

A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk of this severe and sometimes deadly form of high blood pressure. The test can identify with 96% accuracy which women with sometimes-vague symptoms will develop preeclampsia within the following two weeks, The New York Times reported this week. “It’s groundbreaking. It’s revolutionary,” Dr. Douglas Woelkers, a professor of maternal-fetal medicine at the University of California, San Diego, said of the test. “It’s the first step forward in preeclampsia diagnostics since 1900, when the condition was first defined,” Woelkers added in the news report. The blood test was created by Thermo Fisher Scientific. It is meant for women in the 23rd to 35th weeks of pregnancy. Those who don’t test positive can be safely discharged from the hospital, while two-thirds of those with a positive result will advance to severe preeclampsia. Women who are positive may need to deliver their babies early. “We don’t have a therapy that reverses or cures preeclampsia other than delivery of the baby, which is more like a last resort,” Woelkers said in the news report. Black women are particularly at risk of preeclampsia, with much higher rates than white women. They are also more likely to experience kidney damage, death and to lose their babies, the Times…  read on >  read on >