Couple on Bench River loneliness-g533b52d5a_640The approval of a new drug to treat Alzheimer’s disease is controversial.

The U.S. Food and Drug Administration gave full approval to the drug lecanemab (Leqembi) Thursday to treat adults with Alzheimer’s disease.

In January, Public Citizen, a consumer advocacy organization, urged the agency not to approve the drug. In a letter to the FDA, it said that lecanemab investigators have concluded that longer trials are needed to determine the effectiveness and safety of lecanemab in early Alzheimer’s disease, and that three deaths thought to be related to the drug have now occurred in lecanemab subjects.

In June, Public Citizen urged the agency not to grant full approval because the evidence for the drug’s benefits doesn’t outweigh its significant risks..

The FDA’s decision to grant full approval for lecanemab to treat adult patients with Alzheimer’s disease is misguided and very disappointing, said Robert Steinbrook, M.D., director of Public Citizen’s Health Research Group.

“The evidence for the drug’s clinical benefits does not outweigh its substantial health risks,” Steinbrook said. “The fact that a black box warning for brain swelling and bleeding risks has been added to the prescribing information for lecanemab underscores the substantial safety concerns.”

Patients with Alzheimer’s disease and their families are understandably desperate for better treatments, he said. However, Steinbrook added, when it approves drugs for Alzheimer’s disease with little or no benefit and significant health risks, the FDA fails patients and the public.

Families should consider the pros and cons of having a loved one take lecanemab carefully. In addition to possible harmful side effects, the drug also is very expensive. The cost, without coverage, could be more than $26,000 annually for the drug, which is delivered by an intravenous infusion every two weeks..

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Rita Robison Consumer & Personal Finance Journalist

For more than two decades, Rita R. Robison has been a consumer and personal finance journalist making her living by finding the best bargains, calling out the crooks, and advocating for regular people just like you and me. In that time, Robison has talked to so many people who feel like their money just isn’t getting them what they want, where they want to be, or the life they thought it would.

The purpose of her blog is to help you get what you want from your money. Robison covers financial goals, budgets, debt reduction, saving, smart choices for buying goods and services, and retirement planning. You’ll also find articles on safety, such as avoiding scams, looking out for rip off companies, and getting informed on the latest recalls.

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