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Growing Calls For Labelling Changes With Obesity Patients In Mind

 
• By Ed Silverman

Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.

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Key Takeaways
  • Advocates and academics argue that many existing medications lack proper labeling for people with obesity, leading to potential patient harm and ineffective care. They are urging the FDA to require pharma companies to include obese individuals in clinical trials and update product labels accordingly.
  • Obesity is a significant and growing issue, with over 40% of US adults classified as obese as of August 2024. This underscores the importance of ensuring that drug studies and labeling accurately reflect the needs of this population to provide safe and effective treatments.
  • Specific drugs like Merck's posaconazole and Otsuka/Lundbeck's Rexulti have been highlighted for their inadequate labeling regarding obesity. Independent research shows these drugs behave differently in obese patients, but this information is not reflected in their labels, potentially leading to suboptimal treatment outcomes.

As the pharmaceutical industry invests more money than ever before to develop new weight loss treatments, a growing number of patient advocates and academics say companies have, ironically, failed to sufficiently

This lack of information has consequences, according to industry critics. They point to independent research showing that different dosages for some existing medicines can affect the way the drugs work in people with obesity

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Growing Calls For Labelling Changes With Obesity Patients In Mind

 
• By Ed Silverman

Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.

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