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POWER SPORT THE-BEAUTY

Drug recalls are common

Multicolored pills, tablets, and gel medicines spilling onto a bright yellow background and surrounded by emptied silver blister packs for medications

Scientific advances have brought us scores of new drugs in recent years. In the US, one major agency — the FDA — is responsible for making sure that the drugs they approve are safe and effective. Yet there were more than 14,000 drug recalls in the last 10 years, according to FDA statistics. That averages out to nearly four drug recalls a day!

Why are drug recalls so common, and how can you maximize safety when taking the medicines you need?

Why do so many drug recalls occur?

The FDA approves prescription drugs if research shows a medicine is safe and effective. Usually the risks are well known by the time approval is granted. For over-the-counter drugs, the bar is lower: proof that they work is not required, but the FDA still maintains oversight for safety.

Drug recalls are common because:

  • Rare side effects may be missed in clinical trials. Studies leading to drug approval might have hundreds or thousands of study subjects. But a rare problem may not be detected until tens of thousands of people have taken a drug.
  • Study subjects tend to be healthier than the general population. When you’re trying to figure out if a drug works, the chances of success are higher and reliability of results is greater if study subjects are healthy. Once a drug is approved, people taking it may be older, less healthy, or taking multiple drugs for health issues.
  • Problems during or after manufacturing can make a safe drug harmful. Examples include bacterial contamination, incorrect labeling, and improper storage.
  • Bad behavior by drug makers may affect drug safety. For example, multiple over-the-counter supplements marketed for male sexual performance were recalled in recent years because they were laced with prescription drugs for erectile dysfunction.

Are most drug recalls high-risk?

Fewer than one in 10 poses a serious health risk. The FDA grades risk severity for recalls as follows:

  • Class I is dangerous and poses a serious health risk (a hand sanitizer contaminated with methanol)
  • Class II might cause a temporary or slight risk of serious harm (a diabetes medicine stored at the wrong temperature)
  • Class III is unlikely to cause any harm to health, but there is a violation of FDA requirements (an ointment for dermatitis in damaged tubes).

Between 80% and 90% of drug recalls are Class II.

In 2022, 6% of recalls were Class 1, 86% were Class II, and 7% were Class III.

How do drug recalls happen?

The FDA inspects drug manufacturing facilities every two to three years. The agency also tests thousands of drugs each year.

Problems spotted during inspections, concerns identified by drug makers, or problems reported by patients or health care professionals can prompt a recall. The FDA then assigns a risk classification, supervises actions taken by the drug maker to remedy the problem, and monitors the product to make sure the problem is eliminated.

Drug recalls in the US are almost always voluntary. That means the drug maker acknowledges the problem and takes corrective action rather than waiting for a possible mandate from the FDA.

How can you stay informed about medicines you use?

Here are some practical measures to take:

  • Sign up to receive texts or emails about recalls, market withdrawals, and safety alerts from the FDA.
  • When filling prescriptions, take a good look at your medicine. Pills should not be discolored or crumbling, or have an unusual odor. If your prescription hasn’t changed, a refill should look similar to what you’ve taken in the past. If you suspect a problem, contact your pharmacist or the health care professional who prescribed it. And if you do confirm a problem, you can report it to the FDA.
  • If you learn of a recall for a drug you take, check the lot number on the package to see if your medication is affected. If the risk is classified as high (Class I), contact your doctor right away for advice. For many recalled drugs, there are safe and effective alternatives.
  • A recall notice will tell you if the medicine can be replaced or if you can be reimbursed. If you are instructed to dispose of medication, do so safely.

Another way to limit your potential exposure to recalled drugs is to take fewer drugs. Review your medication list with your doctor regularly and take only what you truly need.

The bottom line

News on drug recalls may not inspire confidence. It might make you wonder if the drugs you take are safe. In general, yes: the vast majority of medicines on the market have an excellent safety profile. But with more than 1,000 drug recalls every year, there’s plenty of room for improvement by drug makers and good reason to encourage better regulation of the industry.

Follow me on Twitter @RobShmerling

About the Author

photo of Robert H. Shmerling, MD

Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School. … See Full Bio View all posts by Robert H. Shmerling, MD

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POWER SPORT THE-BEAUTY

Does less TV time lower your risk for dementia?

Smiling couple sitting on couch watching TV; man with short brown hair points remote, woman has white hair; bowl of popcorn rests on blanket

Be honest: just how much television are you watching? One study has estimated that half of American adults spend two to three hours each day watching television, with some watching as much as eight hours per day.

Is time spent on TV a good thing or a bad thing? Let's look at some of the data in relation to your risks for cognitive decline and dementia.

Physical activity does more to sharpen the mind than sitting

First, the more time you sit and watch television, the less time you have available for physical activity. Getting sufficient physical activity decreases your risk of cognitive impairment and dementia. Not surprisingly, if you spend a lot of time sitting and doing other sedentary behaviors, your risk of cognitive impairment and dementia will be higher than someone who spends less time sitting.

Is television actually bad for your brain?

Okay, so it's better to exercise than to sit in front of the television. You knew that already, right?

But if you're getting regular exercise, is watching television still bad for you? The first study suggesting that, yes, television is still bad for your brain was published in 2005. After controlling for year of birth, gender, income, and education, the researchers found that each additional hour of television viewing in middle age increased risk for developing Alzheimer's disease 1.3 times. Moreover, participating in intellectually stimulating activities and social activities reduced the risk of developing Alzheimer's.

Although this study had fewer than 500 participants, its findings had never been refuted. But would these results hold up when a larger sample was examined?

Television viewing and cognitive decline

In 2018, the UK Biobank study began to follow approximately 500,000 individuals in the United Kingdom who were 37 to 73 years old when first recruited between 2006 and 2010. The demographic information reported was somewhat sparse: 88% of the sample was described as white and 11% as other; 54% were women.

The researchers examined baseline participant performance on several different cognitive tests, including those measuring

  • prospective memory (remembering to do an errand on your way home)
  • visual-spatial memory (remembering a route that you took)
  • fluid intelligence (important for problem solving)
  • short-term numeric memory (keeping track of numbers in your head).

Five years later, many participants repeated certain tests. Depending on the test, the number of participants evaluated ranged from 12,091 to 114,373. The results of this study were clear. First, at baseline, more television viewing time was linked with worse cognitive function across all cognitive tests.

More importantly, television viewing time was also linked with a decline in cognitive function five years later for all cognitive tests. Although this type of study cannot prove that television viewing caused the cognitive decline, it suggests that it does.

Further, the type of sedentary activity chosen mattered. Both driving and television were linked to worse cognitive function. But computer use was actually associated with better cognitive function at baseline, and a lower likelihood of cognitive decline over the five-year study.

Television viewing and dementia

In 2022, researchers analyzed this same UK Biobank sample with another question in mind: Would time spent watching television versus using a computer result in different risks of developing dementia over time?

Their analyses included 146,651 people from the UK Biobank, ages 60 and older. At the start of the study, none had been diagnosed with dementia.

Over 12 years, on average, 3,507 participants (2.4%) were diagnosed with dementia. Importantly, after controlling for participant physical activity:

  • time spent watching television increased the risk of dementia
  • time spent using the computer decreased the risk of dementia.

These changes in risk were not small. Those who watched the most television daily — more than four hours — were 24% more likely to develop dementia. Those who used computers interactively (not passively streaming) more than one hour daily as a leisure activity were 15% less likely to develop dementia.

Studies like these can only note links between behaviors and outcomes. It's always possible that the causation works the other way around. In other words, it's possible that people who were beginning to develop dementia started to watch television more and use the computer less. The only way to know for sure would be to randomly assign people to watch specific numbers of hours of television each day while keeping the amount of exercise everyone did the same. That study is unlikely to happen.

The bottom line

If you watch more than one hour of TV daily, my recommendation is to turn it off and do activities that we know are good for your brain. Try physical exercise, using the computer, doing crossword puzzles, dancing and listening to music, and participating in social and other cognitively stimulating activities.

About the Author

photo of Andrew E. Budson, MD

Andrew E. Budson, MD, Contributor; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Andrew E. Budson is chief of cognitive & behavioral neurology at the Veterans Affairs Boston Healthcare System, lecturer in neurology at Harvard Medical School, and chair of the Science of Learning Innovation Group at the … See Full Bio View all posts by Andrew E. Budson, MD