U.S. FDA orders GLP-1 drugmakers to add blindness risk warning

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FDA blindness warning for GLP-1 drugs

Highlights

FDA orders makers of GLP-1 receptor agonists, including Eli Lilly and Novo Nordisk, to add blindness risk warning to drug labels on July 8, 2024.
FDA review finds GLP-1 users face a Naion incidence rate of 6.4 events per 100,000 person-years versus 3.8 for controls, highlighting a potential risk increase.
The label update and underlying safety concerns may intensify scrutiny of GLP-1 drugs as their widespread adoption affects healthcare spending and related sectors.

Label change follows FDA safety review

As reported by Financial Times, citing the Food and Drug Administration, the agency said on Monday that it will require makers of GLP-1 receptor agonist medicines to add information to the warnings and precautions section of their labels about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, or Naion.

The regulator said it is informing patients and healthcare providers about the possible increased risk of the rare but serious eye condition, which can cause acute, painless, decreased vision in one eye, including permanent vision loss. It added that Naion cases have been reported for all currently marketed GLP-1 products and that its reviews and analysis conclude there is a potential increased risk of rare Naion events in patients taking the drugs.

The requirement applies to companies such as Eli Lilly, Novo Nordisk and other application holders for GLP-1 medicines. Novo said patient safety is a top priority and that it will continue to monitor the safety of its medicines and work with health authorities globally, while saying it remains confident the benefits of GLP-1 drugs outweigh the risks. Eli Lilly does not immediately respond to a request for comment.

Study evidence and broader market implications

Monday's announcement cites a July 2024 article in the peer-reviewed journal Jama Ophthalmology examining Naion risk among GLP-1 users. The FDA says it identifies several limitations in that study, but decides that further assessment of the potential risk is warranted.

After the study was published, the agency says it undertakes a comprehensive evaluation of clinical trial data, animal data and postmarketing data, including observational studies and case reports. It also says its meta-analysis of clinical trials shows a Naion incidence rate of 6.4 events per 100,000 person-years in subjects treated with GLP-1s, compared with 3.8 events per 100,000 patient-years for those given control treatment.

The decision is likely to intensify debate over the drugs' side effects and their wider economic impact as use expands. That discussion increasingly extends beyond patient safety to how widespread adoption of weight-loss treatments could influence healthcare spending, consumer activity and related markets.

Earlier, we reported that S&P Global Ratings warned geopolitical tensions and elevated fiscal spending are raising sovereign borrowing risks as funding costs stay high.

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