Drugs after 60 – And Not The Fun Kind

I react badly to most medications – sometimes badly enough to warrant a MedWatch report to FDA. A bit ironic, given that I spent my career in biotech writing submissions to FDA for product approvals. But knowing what I do about medical regulation, it did not surprise me to learn that the American Geriatric Society has developed the Beer’s List of approved medications they do not recommend prescribing to adults over 65.

If you have ever read the package insert for a medication, you know that drug labeling lists warnings and contraindications, including who should not take the drug. So you might wonder: Why do we need the Beer’s List? Doesn’t FDA make drug companies study the effects of new products on older people?

Let me tell you a story.

Three years ago I consulted for an organization that develops immune-based therapies for cancer. My job was to write protocols for clinical studies on these drugs. Midway through writing one of the protocols, I found out FDA had just published a new guidance for industry calling for inclusion of patients over 65 in cancer clinical trials. FDA pointed out the preponderance of patients needing these drugs were in that older age group. Sounds reasonable, but think about what else that means: Until that 2021 guidance, researchers were free to exclude older persons from cancer trials. I’d worked for decades on studies of diagnostics, devices, and medicines that excluded older people, and never gave it a thought, until that moment in my sixties when I read the new guidance. Chalk that one up to internalized ageism.

Even now, studies point out that “Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments’ efficacy, and safety.” But older adults are not the only ones underrepresented; this is an intersectional problem. Historically, the young or midlife white male was considered the “norm” for inclusion in clinical studies. Until 1996, FDA did not require inclusion of women in clinical trials. In fact, in 1977 FDA had banned women of childbearing potential from participation in Phase I or Phase II trials. People of color were often excluded from trials until passage of the Civil Rights Act prompted the NIH to warn drug companies that discrimination was illegal; yet to this day, people of color remain underrepresented in clinical trials.

While there is movement in the direction of greater inclusion for new medical products, keep in mind that when FDA adds new requirements for approval, products already on the market do not need to meet those requirements. As a result, for existing medications, the only data about whether a medication is safe and effective for a subgroup such as older persons is from adverse events. Hence the need for the Beer’s List.

But keep in mind that the list, while a good idea, is not the only word on any given medication. For example, the 2023 Beer’s List recommends taking women over 65 off estrogen, whereas the 2022 report by the North American Menopause Society (NAMS) says this: “There is no general rule for stopping systemic hormone therapy in a woman aged 65 years. The Beers criteria from the American Geriatrics Society has warnings against the use of hormone therapy in women aged older than 65 years. However, the recommendation to routinely discontinue systemic hormone therapy in women aged 65 years and older is neither cited or supported by evidence nor is it recommended by the American College of Obstetricians and Gynecologists or The North American Menopause Society.”

Bottom line: It pays to be a skeptical consumer of medical advice. If you are prescribed a medication on the Beers List, proceed with caution. Check to see if the research supports inclusion on the list. And if you are prescribed a medication that is not on the list, it pays to check the package insert that comes with the drug. And even better, read what medical journals have to say about the drug. Case in point: Ototoxicity, or hearing loss caused by medications.

Ear Damage from Medications

Certain medications are known to risk damage to the ear, which can manifest as ringing in the ears (tinnitus) or as hearing loss. These hearing problems are more common among older adults. But ototoxicity is not cited on the Beers List as a reason for inclusion.

The Mayo Clinic has published a list of ototoxic medications, including a number that are not on the Beers List. So it is useful to keep both lists on hand. And keep in mind, too, that the Mayo Clinic list is not exhaustive. The article that accompanies the list recommends checking with your physician if tinnitus occurs when starting any new medication.

Deprescribing for Older Adults

Clinical trials study the safety and effectiveness of drugs, including the lowest dosage at which a medication does its job. The tricky part is, optimal dosage can be different for various subgroups including children, women, and older persons. As we age, our ability to metabolize medications changes. A drug can stay in our system longer, meaning that a safe dose for a younger adult can be toxic for us. So unless clinical studies include older persons, and unless their data is analyzed as a separate subgroup, the dosage recommended on a drug label may be too high.

And while FDA requires companies to study the combined effects (cross reactivity) of certain combinations of drugs, the agency typically requires the new medication be studied with only a few other drugs that are often co-prescribed. And these studies are one-on-one studies: New drug A with existing drug B, and a separate study of new drug A with existing drug C. There is typically no study of A plus B plus C. Yet we know that more than half of persons over 65 report taking four or more prescription medications.

This combination of issues leads to polypharmacy, which is overprescription of medications to older adults, typically women. As a result there is a movement afoot to look at each individual’s full range of prescriptions, to carefully lower dosages, and to eliminate prescriptions where possible for older adults. Canadian researchers founded the deprescribing.org site to gather research and guidelines for this important work.

Conclusions for Drugs after 60 and Not The Fun Kind

When it comes to medications after sixty, it pays to be a savvy consumer. The more we know, the better able we are to navigate health care settings for ourselves and those we care for. Each of us has lived in our body for a long time and know it well; yet our bodies change all the time, and self-care requires that we learn about ourselves as we are now.

In that way, we can partner most effectively with our healthcare providers.