FDA trims use of contentious Alzheimer's drug amid backlash

The Food and Drug Administration has approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer's drug

WASHINGTON -- U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug. The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month. The new drug label emphasizes that the drug, Aduhelm, is appropriate for patients with early or mild Alzheimer's but has not been studied in patients with more advanced disease. That's a big change from the original FDA instructions, which said simply that the drug was approved for Alzheimer's disease in general. Drugmaker Biogen announced the change in a release Thursday, stating that the update is intended to “clarify” the patients studied in the company trials that led to approval. The FDA first approached the company about narrowing the label and approved the language.