The Box Debate: Should New Diet Drugs Carry a Warning Label?

New diet drugs are emerging as powerful tools in the fight against obesity. However, their effectiveness comes with a potential cost – side effects. This has reignited the debate about boxed warnings on these medications. Already, there is a group lawsuit, with over 11,000 people, against the makers of diet drugs because of severe side effects.

More than 3 million prescriptions for the new medications are dispensed each month in the U.S., according to recent data from the health technology company IQVIA. They include semaglutide, the drug in Ozempic and Wegovy, and tirzepatide, the drug in Mounjaro and Zepbound.

One recent study published in Obesity found that just 40% of patients who filled a prescription for Wegovy in 2021 or 2022 still took it a year later. However, patients are suing Eli Lilly and Novo Nordisk, the two companies that make drugs within this class of medication, saying they suffered distressing digestive symptoms, such as gallbladder removal or gastroparesis, after taking the drug.

More than five dozen lawsuits accuse Novo Nordisk or Eli Lilly of failing to notify patients about the side effects of their widespread diabetes or weight loss drugs. Those drugs include Novo Nordisk’s Ozempic, Wegovy, Rybelsus, and Eli Lilly’s Trulicity and Mounjaro. These personal injury cases have been centralized under a federal judge in Philadelphia because they share common elements involving the same class of drugs.

Should there be a Boxed Warning?

What is a Boxed Warning?

A boxed warning is the most vital safety communication from the FDA. It highlights serious or life-threatening risks associated with a drug. Proponents of boxed warnings for new diet drugs argue that these medications can have significant side effects, including:

  • Increased risk of certain cancers: Studies have shown a link between some GLP-1 receptor agonist drugs (a typical class of diet drugs) and thyroid tumors in animals. While the risk in humans is unclear, a boxed warning would ensure transparency.
  • Mental health concerns: Recent reports suggest a possible link between diet drugs and suicidal ideation. A boxed warning could prompt closer monitoring and earlier intervention for mental health issues.
  • Severe gastrointestinal issues: Nausea, vomiting, and diarrhea are common side effects of these drugs. A boxed warning would inform patients about these potential disruptions to their daily lives.

Are Boxed Warnings Necessary?

Opponents of boxed warnings argue that they might discourage patients from seeking potentially life-changing weight loss solutions. They point out that:

  • Risks can be managed: Doctors can carefully screen patients for pre-existing conditions that might increase risks and closely monitor patients taking the medication.
  • Benefits outweigh risks: For many people struggling with obesity, the health risks associated with their weight far outweigh the potential side effects of the medication.
  • Focus on education: Clear and comprehensive patient education materials can effectively communicate risks without resorting to a boxed warning.

Finding the Balance

The debate highlights the need for a balanced approach. Here are some possibilities:

  • Tiered warnings: Depending on the severity and likelihood of side effects, different levels of warnings could be implemented, with boxed warnings reserved for the most severe risks.
  • Emphasis on shared decision-making: Doctors can discuss the risks and benefits of new diet drugs with patients, allowing them to make informed decisions about their treatment plans.

Ultimately, the goal is to ensure patients can access safe and effective weight loss solutions. Open communication between doctors and patients and clear and informative risk communication from drug manufacturers will be crucial in navigating this complex issue.