When FDA Approval Isn’t Enough: Rethinking Medication Safety for Older Adults

In June 2025, investigative journalist Maryanne Demasi published a striking article titled “FDA exposed – hundreds of drugs approved with no proof they work”. Drawing from a 10-year analysis of FDA drug approvals, the article raised an uncomfortable truth: many drugs on the market, especially those given to our most vulnerable, were approved with little to no solid evidence that they actually improve patient outcomes.

At GeriatRx, we’ve long believed that not all medications are created equal. Our mission is rooted in ensuring every drug a patient takes is necessary, effective, and evidence-based. Demasi’s findings only reinforce why that work is more important than ever, particularly for older adults who are more likely to be on multiple prescriptions at once.

What the Report Uncovered

Between 2013 and 2022, researchers found that fewer than 1 in 3 FDA-approved drugs met basic quality standards in their supporting trials: randomized control, replication, blinding, and clinically meaningful outcomes. Even more concerning, some drugs were approved with none of those elements.

Demasi explains that “a significant proportion of new drugs approved by the FDA in the last decade were based on weak evidence,” often relying on surrogate markers like tumor shrinkage instead of real-world benefits like improved survival or quality of life. This problem was particularly glaring in oncology, where only 3 out of 123 cancer drugs met the four key trial criteria.

And even when the FDA requires post-market studies to verify benefit or flag risks, nearly half of those commitments are either delayed or never completed.

Why This Matters in Geriatric Care

The average older adult takes between 5 to 10 medications a day. This makes them uniquely vulnerable to drugs with weak evidence, hidden risks, or unclear benefit. When a new medication is introduced into an already complex regimen, the risks of side effects, drug interactions, or cognitive decline multiply, especially if that medication never had strong supporting data in the first place.

At GeriatRx, this is why we don’t just look at whether a drug is FDA approved. We look at how it was approved and whether it actually improves health and quality of life in real-world settings.

The Cost of Assuming Safety

Several examples in the article highlight the long-term cost of letting weakly supported drugs remain in use:

• Copiktra, a cancer drug, was approved based on progression-free survival, but later analysis showed it may have reduced overall survival in certain patients. A safety warning wasn’t issued until six years later.

• Elmiron, approved in the '90s for bladder pain, stayed on the market for over 25 years despite evidence of serious adverse effects—including vision loss—without ever proving it worked better than placebo.

• Even Avastin, once heralded as a breakthrough for metastatic breast cancer, had its approval rescinded for that use after post-market trials failed to show benefit. But that decision came only after widespread use and public resistance.

  
  

These stories remind us that FDA approval is not a guarantee of safety or effectiveness. It’s a starting point for scrutiny, not the finish line.

How GeriatRx Bridges the Gap

At GeriatRx, our approach is rooted in precision, transparency, and empowerment.

• Medication Reviews: We analyze each drug a patient takes—not just what it treats, but what evidence supports its use in that specific context.

• Deprescribing: If a drug doesn’t offer meaningful benefit or poses more risk than reward, we develop a safe and collaborative plan to reduce or stop it.

• Education for Families & Providers: We translate complex research and regulatory data into clear, actionable insights so that patients and care teams can make informed choices.

• Advocacy: We push for higher standards in clinical care, greater awareness of regulatory gaps, and safer medication practices for aging populations.

What You Can Do

Whether you're a caregiver, a clinician, or someone managing your own health, here are three simple ways to protect yourself or a loved one:

1. Ask questions about how each medication was approved and whether it improves survival, function, or quality of life.

2. Review your medication list at least once a year with a professional trained in deprescribing.

3. Be cautious with new prescriptions, especially if they’re fast-tracked or recently approved without long-term data.

Final Thoughts

As Demasi put it, “The FDA has increasingly lowered its approval standards,” and the public often assumes that an approved drug has been rigorously vetted. But in many cases, that assumption is wrong.

At GeriatRx, we’re working to change that one patient at a time. We believe that medication safety isn’t just about avoiding harm; it’s about ensuring every drug actually helps. When it doesn’t, we help people take back control with less medication, more clarity, and better outcomes.