A new opinion piece published in Health Affairs Forefront raises questions around current approaches to assess drug safety and effectiveness in people with obesity. The article sheds light on how increased body fat can modify the effects of drugs used to treat common conditions, in some cases rendering the drugs ineffective or unsafe for people with obesity.
The article, titled “Assessments Of Drug Safety And Effectiveness Continue To Fail People With Obesity,” argues that drug manufacturers should be required to show correct dosing instructions on their labels for people with obesity when they are well-known and, when appropriate, include people with obesity in clinical trials during the drug approval process.
People with obesity deserve to know that the prescription drugs they take are safe and effective for them. Today, neither patients nor their providers know how some drugs may act differently in people with obesity.”
William Dietz, Director of the STOP Obesity Alliance at The George Washington University, and one of the paper’s authors
According to the article, the FDA has recognized that people with obesity are often intentionally excluded from clinical trials in an effort to reduce the observed variability of early-phase trials. For some drugs, this makes little or no clinical difference. But with drugs that are lipophilic, meaning highly fat soluble, the difference in clinical impact for patients with obesity