Advocates for the use of the psychedelic drug MDMA (midomafetamine) to treat mental health conditions were delivered a setback on Friday after the U.S. Food and Drug Administration declined to approve it as treatment for post-traumatic stress disorder (PTSD). There is insufficient evidence that MDMA — currently illegal and also known as Ecstasy or molly — can ease PTSD, the agency told Lykos Therapeutics, a company that’s been seeking to gain approval for the drug’s legitimate use. The FDA asked that Lykos conduct another clinical trial to determine whether MDMA is safe and effective against PTSD — a demand that could mean many years and millions of dollars before another chance at approval would arise. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Lykos Therapeutics CEO Amy Emerson said in a statement. “While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the [agency’s] advisory committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson added. Many had…  read on >  read on >

Eating more fruits and veggies can lower blood pressure and improve heart health by reducing acid levels in the body, a new clinical trial finds. People who added two to four cups of fruits and vegetables to their daily diet wound up with lower blood pressure and reduced heart disease risk, as well as improved kidney health, trial results published Aug. 6 in the American Journal of Medicine showed. “This supports our recommendation that fruits and vegetables should be ‘foundational’ treatment for patients with hypertension, because we accomplish all three goals [kidney health, lower blood pressure and reduced cardiovascular disease risk] with fruits and vegetables, and we can do so with lower medication doses,” said researcher Maninder Kahlon, an associate professor of population health with the University of Texas at Austin Medical School. In other words, doctors should first have people eat more fruits and veggies before starting them on blood pressure medications, the researchers said. “Dietary interventions for chronic disease management are often not recommended and even less often executed because of the many challenges to get patients to implement them,” explained lead researcher Dr. Donald Wesson, a professor of internal medicine with the University of Texas at Austin. “Nevertheless, they are effective, and in this instance, kidney- and cardiovascular-protective.” “We must increase our efforts to incorporate them into patient management and more broadly,…  read on >  read on >

Millions of Americans use the opioid-like herbal supplement known as kratom, but evidence of its dangers continue to mount. The U.S. Food and Drug Administration has issued another alert for consumers to stay away from one brand of kratom in particular, OPMS Black Liquid Kratom. “The FDA recently received an adverse event report of a person who died after using OPMS Black Liquid Kratom,” the agency noted. “This is one of many reports of serious adverse events individuals have reported” after using the supplement, the FDA added. Kratom is an herbal supplement derived from the dried leaves of a tropical evergreen tree in the coffee family. A chemical called mitragynine, found in kratom, tweaks some of the same brain receptors that respond to opioids. However, overdoses of mitragynine are toxic to the liver and can prove fatal. Kratom has been used for centuries in its native Southeast Asia to produce increased energy and relaxation, according to the U.S. National Institute on Drug Abuse. The drug is largely unregulated: Anyone can buy kratom online, and it can be found in convenience stores, gas stations and vape shops. Some bars serving botanical drinks offer kratom tea. About 1.7 million people 12 and older used kratom in the United States in 2021, according to the National Survey on Drug Use. The new alert from the FDA noted that…  read on >  read on >

Prior studies have found that statin meds can help lower liver cancer risks, and new research suggests that at least one non-statin cholesterol drug can do the same. A team led by Katherine McGlynn of the U.S. National Cancer Institute looked at the health histories of almost 19,000 people tracked by the U.K.’s Clinical Practice Research Datalink.  About 3,700 of them developed liver cancer, and their medication use was compared to almost 15,000 others who did not get the disease. McGlynn’s team linked use of a non-statin form of cholesterol-lowering meds, called cholesterol absorption inhibitors, to 31% lower odds of developing liver cancer. Their findings were reported July 29 in the journal Cancer. The link held when the researchers accounted for other risk factors such as diabetes and liver disease status.  The study also re-confirmed that statins lower liver cancer risk by 35%. But the use of three other medicines used to lower cholesterol — fibrates, omega-3 fatty acids and niacin — did not seem to affect liver cancer risk, the research showed. Risks attributed to another drug type, bile acid sequestrants, were inconclusive. “As few studies have examined the effects of non-statin cholesterol-lowering drugs on liver cancer risk, the results of our study require replication in other populations,” McGlynn said in a journal news release. “If our findings are confirmed in other studies, however,…  read on >  read on >

People taking compounded versions of Ozempic have been overdosing on the drug, the U.S. Food and Drug Administration warns. These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA added. “Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug,” the FDA alert said. Health problems caused by overdoses of compounded semaglutide — the main ingredient in Ozempic and Wegovy — include severe nausea, vomiting and hypoglycemia, the FDA said. Other side effects include fainting, headache, migraine, dehydration, pancreatitis and gallstones. People who have a severe overdose might need to be kept for observation for an extended period, since the half-life of semaglutide is about a week, the FDA said. Drug compounding involves combining, mixing or altering drugs to create a medication tailored to the needs of an individual patient. “FDA is aware of compounded semaglutide products that are being marketed for weight loss,” the agency said. “Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness.” “Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug,” the agency added. Compounded semaglutide products can come in varying concentrations, and often are provided in multiple-use vials…  read on >  read on >

An additional cinnamon product sold in the United States has been found to contain high levels of lead, health officials are warning. In a health alert issued Thursday, the U.S. Food and Drug Administration said the ground cinnamon product, sold as El Servidor, joins a growing list of cinnamon products that have contained high levels of lead. Through testing, the cinnamon was found to have elevated lead levels at 20 parts per million. Although the FDA doesn’t set limits for lead levels in spices, the United Nations’ Food and Agriculture Organization has a proposed international safety standard of 2.5 parts per million of lead for bark spices like cinnamon, NBC News reported. The FDA noted that it has asked the distributor to recall the product. Lead in cinnamon products has become a growing problem: In March, the FDA warned about lead in fruit puree products sold at Dollar Tree, Family Dollar and other stores. Those products had levels of lead ranging from 2.03 to 3.4 parts per million. The cinnamon identified in the new alert was sold at a supermarket in New York City, although it’s unclear whether it was distributed more widely. Leigh Frame, director of integrative medicine at George Washington University School of Medicine and Health Sciences, told NBC News that the new recall was “alarming.” “We sort of assume things are safe until proven otherwise,” Frame…  read on >  read on >