The record
Written from the 1 report below. Nothing here is unsourced.
- Lawsuits have been filed in the United States against pharmaceutical manufacturers alleging that certain weight loss and diabetes medications are linked to sudden vision loss.
- Plaintiffs claim the companies failed to provide adequate warnings about the condition known as nonarteritic anterior ischemic optic neuropathy.
- Novo Nordisk and Eli Lilly have both disputed the allegations and emphasize their commitment to patient safety and ongoing regulatory monitoring.
- Regulators in Europe and Australia have already mandated warnings regarding this potential side effect for specific drugs.
- Further investigation by the US Food and Drug Administration remains ongoing to determine if a formal link exists.
What to watch next
- Results of the ongoing US Food and Drug Administration Sentinel Initiative review
- Developments in the ongoing personal injury lawsuits in the United States
Who said what3
Only words found exactly in the article are shown, attributed and linked to the line they came from.
Novo Nordisk
1 quote · 1 outlet
“Novo believes the personal injury lawsuits filed in the U.S. are without merit and are vigorously defending them”
In the article
…is a link between the medicines and the eye condition. Novo Nordisk, which makes Ozempic and Wegovy, said it takes “all reports of adverse events very seriously” but disputed the allegations made in the lawsuits. “ Novo believes the personal injury lawsuits filed in the U.S. are without merit and are vigorously defending them ,” a company spokesperson told ABC News. The company added, "Novo is committed to patient safety and continuously monitors the safety profile of our GLP-1 RA products. Should emerging safety data warrant further action,…
Eli Lilly
1 quote · 1 outlet
“Patient safety is Lilly’s top priority. We actively monitor, evaluate, and report safety information for all our medicines to the FDA.”
In the article
…action, appropriate measures will be implemented in accordance with regulatory requirements.” Eli Lilly, the manufacturer of Mounjaro and Zepbound, also said it continuously monitors the safety of its medicines. “ Patient safety is Lilly’s top priority. We actively monitor, evaluate, and report safety information for all our medicines to the FDA. As part of our routine safety review process, we have ongoing discussions with regulators regarding potential safety topics, and we will continue to review data, including any data regarding ophthalmic issues," a…
US Food and Drug Administration
1 quote · 1 outlet
“The FDA routinely monitors the safety of drug products postmarketing. The FDA identifies safety signals from a variety of sources, evaluates the available data and takes regulatory actions when appropriate”
In the article
…to specifically mention NAION as a risk on their labels. The FDA's Sentinel Initiative is conducting a review to assess the possible safety signal involving GLP-1 drugs and NAION. The review is still under way. " The FDA routinely monitors the safety of drug products postmarketing. The FDA identifies safety signals from a variety of sources, evaluates the available data and takes regulatory actions when appropriate ,” an FDA spokesperson said in a statement provided to ABC News. Regulators in some other countries have taken a different approach based on their assessment of the available evidence. The European Medicines Agency and…
Coverage1
All filed from India
Named United States · Australia · Eli Lilly · Mounjaro · Novo Nordisk · Ozempic · Wegovy · Zepbound · European Medicines Agency · Therapeutic Goods Administration · US Food and Drug Administration
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