Over the years, we’ve learned that being obese means facing higher levels of health risks than people who maintain a lower weight.
We’ve been warned that obesity:
Now, there’s another obesity-related danger to add to the list — this time from the drug industry.
That’s because according to a paper published in Health Affairs Forefront, being obese can modify the effects of drugs used to treat common conditions. In some cases, it can render the drugs ineffective and in others, downright unsafe for people with obesity.
And shockingly, obese people are intentionally left out of drug trials.
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Drug testing leaves obese people out in the cold
The authors, who are part of the STOP Obesity Alliance at The George Washington University, a group dedicated to reversing the obesity epidemic in the United States, are calling on drug manufacturers to make some big changes to make taking medications safer and more effective for people living with obesity.
“People with obesity deserve to know that the prescription drugs they take are safe and effective for them,” according to William Dietz, Director of the STOP Obesity Alliance. “Today, neither patients nor their providers know how some drugs may act differently in people with obesity.”
How is this even a thing?
For starters, the FDA admits that people with obesity — that’s 41.9 percent of the U.S. population — are often intentionally excluded from clinical trials to reduce the observed variability of early-phase tests.
And, while for some drugs, this makes little or no clinical difference, for others it can create a real and present danger.
This is especially true for lipophilic drugs. Lipophilic means that a drug is highly fat soluble.
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One size does not fit all
One such drug is brexpiprazole (brand name Rexult). It’s a drug that treats schizophrenia and depression, two very serious conditions with life-threatening implications.
In 2015, the FDA approved brexpiprazole without it being tested fully on people with obesity, even though approximately 60 percent of people with schizophrenia also live with obesity.
It wasn’t until 2021 that researchers were able to uncover how Rexulti works in obese patients. The study, conducted by a team from Tufts and Emerald Lake Safety, showed that the drug took significantly longer to reach effective levels in people with obesity.
Even worse, for some patients it never reached an effective level, leaving them to suffer from potentially life-threatening mental and emotional issues. Still, no warning exists on the drug label and no specific guidance is available to providers.
And it’s not the only drug that’s a problem.
Posaconazole (brand name Noxafil) is used to treat fungal infections like candidiasis, which can occur more often in people with obesity. Yet, the researchers were able to show that the half-life of the drug is substantially longer for people who are obese.
This means that it takes longer to clear out of the body, even when you stop taking it, which could result in serious drug interaction even weeks later.
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Big changes are needed
There’s no telling how many more drugs could adversely affect obese people taking them. That’s why the authors have suggested creating a reporting system for adverse events relating to drug metabolism in people with obesity. This would enable the FDA and drug manufacturers to identify and track issues so changes could be made and patients warned.
But that’s not all they are calling for…
They want to see the FDA revise its Clinical Trials Guidance Documents and Regulations Relating to Good Clinical Practice to require testing on people with obesity. And, whenever appropriate, demand that drug manufacturers include information on the effects of obesity on specific drugs in the drug package insert.
If you’re living with obesity, be sure to talk to your doctor about the drugs you’re taking. It’s also important to note that weight can impact the effectiveness of some supplements, as was recently discovered about vitamin D.
However, always follow dosage guidelines and do not deviate from them, unless advised by a doctor.
Sources:
Obesity experts spotlight safety gap in clinical trials and drug labeling for people with obesity — EurekAlert!
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