Homeopathic products intended for use by those with weakened immune systems, infants and children, older adults, and pregnant women, as well as ophthalmic and injectable products, will be prioritized by FDA under a risk-based approach described in a guidance, Homeopathic Drug Products, scheduled for publication in today’s Federal Register. The document explains such categories of homeopathic drug products potentially pose a higher risk to public health or for causing adverse events. FDA anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for enforcement and regulatory action. No FDA-approved products are labeled as homeopathic, and the agency cannot ensure these drugs meet safety, effectiveness, and quality standards. Previously, the FDA has warned the public about certain homeopathic products, including those containing a toxic substance and ones recalled due to contamination.
A consensus is emerging on how to use the new Eisai agent for Alzheimer’s disease that is currently under review at FDA, Stat reports. A major challenge is identifying the right patients who should receive lecanemab (see Nov. 30 PNN report). “Patients who should get lecanemab have mild, early Alzheimer’s disease, called mild cognitive impairment or mild dementia,” explained Jason Karlawish, co-director of the Penn Memory Center at the University of Pennsylvania, at a Stat event earlier this week. Karlawish, a critic of the previously marketed and controversial agent aducanumab, “said that he, as an expert, can identify those patients after an hourlong workup that involves talking to patients and their families. In order for lecanemab to be right for them, they must test positive for having high levels of a substance called amyloid. Right now, such tests are usually done with an expensive positron emission tomography (PET) scan, but Karlawish expressed hope that a blood test could be used to screen patients before conducting brain scans.”