A new drug can slash triglyceride levels nearly in half by targeting a genetic driver of high fat levels in the bloodstream, researchers said. The injectable drug, olezarsen, lowered triglyceride levels by 49% at the 50 milligram (mg) dose and by 53% at the 80 mg dose compared to a placebo, researchers reported April 7 in the New England Journal of Medicine. The findings were presented simultaneously at the American College of Cardiology’s annual meeting in Atlanta. The drug also reduced blood levels of two other contributors to clogged arteries, apolopoprotein B and “bad” cholesterol, results show. Olezarsen inhibits the activity of APOC3, a gene that typically restrains the liver’s ability to filter triglycerides out of the bloodstream, the researchers said. “These findings indicate that targeting APOC3 is a promising new pathway for lowering triglycerides and potentially reducing the risk of heart attack and stroke,” said researcher Dr. Brian Bergmark, of the Brigham and Women’s Hospital Division of Cardiovascular Medicine. Triglycerides are fatty particles in the bloodstream that contribute to the risk of heart disease, both on their own and in combination with “bad” LDL cholesterol, according to Harvard Medical School. For the study, researchers recruited 154 adults already on cholesterol-lowering therapy. They were split into three groups and assigned to either take a placebo or a low or high dose of olezarsen, through injections…  read on >  read on >

New research questions the effectiveness of the U.S. Food and Drug Administration’s accelerated drug approval program after finding that many cancer drugs remain unproven five years later. The study, published Sunday in the Journal of the American Medical Association and presented simultaneously at the American Association of Cancer Research’s annual meeting in San Diego, found that 46 cancer drugs were granted accelerated approval between 2013 and 2017. Of those, 41% showed no benefit after five years of follow-up. And of the 63% that were converted to regular approval, less than half (43%) demonstrated any clinical benefit in confirmatory trials. “Five years after the initial accelerated approval, you should have a definitive answer,” Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the study, told the Associated Press. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.” First created in 1992 to get new HIV drugs to desperate patients as quickly as possible, more than 80% of the program’s accelerated approvals now go to cancer drugs, researchers found. The program allows the FDA to grant early approval to drugs that show promising results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full…  read on >  read on >

A test to gauge if it’s safe to prescribe a patient an addictive opioid may have been approved too soon by the U.S. Food and Drug Administration, claims a letter sent to the agency by a group of experts. The test, called AvertD, is meant to screen for genetic markers suggesting that a person has a higher likelihood of developing an opioid use disorder (OUD). If the test result is positive, doctors could try alternative medications. However, the FDA approved the test in December against the advice of its own advisory panel, the experts noted in their letter. They claim that AvertD is inaccurate and could actually lead to more opioid dependencies, not less. “This test will make the opioid crisis worse,” said Dr. Andrew Kolodny, medical director of opioid policy research at Brandeis University in Massachusetts and one of the those who signed the letter. “It will contribute to overprescribing, it will contribute to an increased incidence of opioid use disorder,” he told NBC News. “In other words, more people becoming newly addicted to opioids.” He and the letter co-authors asked FDA Commissioner Robert Califf  to revoke the agency’s approval. Neither the FDA nor the test’s maker, California-based SOLVD Health, responded to NBC News for comment. According to data from the Substance Abuse and Mental Health Services Administration, over 6.1 million Americans were reported…  read on >  read on >

(HealthDayNews) — Following disappointing trial results, the maker of a controversial ALS drug said it is pulling the medication off the market. In a statement issued Thursday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, and the drug “will no longer be available for new patients as of today.” The medication is sold as Albrioza in Canada. “The decision to remove RELYVRIO/ALBRIOZA from the market and provide therapy free of charge for those who wish to continue was informed by the PHOENIX trial results, engagement with regulatory authorities and discussions with the ALS community,” Joshua Cohen and Justin Klee, co-CEOs of Amylyx, said in the statement. “Thank you to each and every person who shared feedback with us and continues to support our commitment to the ALS community.” The company added that, as of Thursday, “patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to continue can be transitioned to a free drug program.” Relyvrio combines two older drugs: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine. According to the New York Times, about 4,000 patients battling ALS are currently using Relyvrio, which has a list price of $154,000 per year. Relyvrio was first approved by the U.S. Food and Drug Administration in September 2022,…  read on >  read on >

Cutting back on sodium is crucial to treating heart disease, but most heart patients aren’t able to limit their salt intake, a new study finds. On average, people with heart disease consume more than double the daily recommended amount of salt, researchers report. Sodium is essential for human health, but taking in too much can raise blood pressure, which damages blood vessels and forces the heart to work harder, researchers noted. Too much salt also causes the body to retain fluid, which can exacerbate conditions like heart failure. The U.S. Dietary Guidelines recommend that heart disease patients limit sodium to 1,500 miilligrams (mg) per day, and that even healthy people keep their salt intake at less than 2,300 mg/day. But among a sample of more than 3,100 heart patients, nine out of 10 (89%) reported consuming more than the recommended daily maximum of 1,500 mg/day, researchers said. In fact, heart patients consumed an average 3,096 mg/day of salt, only slightly lower than the national average of 3,400 mg/day previously reported by the U.S. Centers for Disease Control and Prevention, the researchers noted. “The relatively small difference in sodium intake suggests that people with cardiovascular disease are not limiting their intake very much compared with the general population and are also consuming more than double what is recommended,” said lead researcher Dr. Elsie Kodjoe, an internal…  read on >  read on >

A new warning is being issued over a heart pump whose use could perforate the heart. The device has already been linked to over 100 injuries and 49 deaths. These left-sided Impella heart pumps are made by Abiomed, a subsidiary of Johnson & Johnson MedTech. Abiomed posted the new warning on the devices on the U.S. Food and Drug Administration’s website. “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the statement said, although it adds that “this recall is a correction, not a product removal.” The advisory informs those implanting the Impella devices about revised instructions for use, including “carefully position the pump catheter during operative procedures.” These Impella pumps resemble a long straw inserted into the heart. They are used during high-risk cardiac procedures (for example, during certain types of heart attack), to help maintain proper blood flow from the heart to the body. The pump is threaded through major heart vessels and into the heart’s left ventricle, the organ’s main pumping chamber. “Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate [cut] the wall of the left ventricle in the heart,” the company warned in its statement. “During operations, the Impella device could cut through the wall of the…  read on >  read on >

Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns. These creams, gels, sprays and soaps are marketed for topical use to relieve the pain of cosmetic procedures like microdermabrasion, laser hair removal, tattooing and piercing, the FDA said. The agency has issued warning lettings to six companies that are marketing products containing concentrations of lidocaine heavy enough to harm people, particularly after cosmetic procedures that could cause the cream to be absorbed more readily through the skin. Products containing lidocaine over 4% can contribute to health problems like an irregular heartbeat, seizures and breathing difficulties, the FDA explained. They also can interact with other medications or supplements a person is taking. “These products pose unacceptable risks to consumers and should not be on the market,” Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “We are committed to using all available tools to stop the sale of these illegal high-risk products.” The companies and products covered by the warning letters include: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine…  read on >  read on >