Anna Hartz
Novo Nordisk Revises Package Inserts to Include Eye Risk
When people take new medications, they expect to know about possible risks. For some patients using weight-loss or diabetes drugs, even very rare side effects can matter.
Novo Nordisk has now updated warnings for several of its products to reflect this, reports Danish news site TV2.
Package Inserts Updated
The company’s medications Rybelsus, Ozempic, and Wegovy all contain the active ingredient semaglutide.
The package inserts for these products in the EU have been updated to note that a rare eye condition, non-arteritic anterior ischemic optic neuropathy (NAION), is a possible side effect.
A “Very Rare” Eye Decease
The update follows guidance from the European Medicines Agency (EMA), which recently revised product information for these medicines.
The wording describes the condition as “very rare,” meaning that statistically fewer than one in 10,000 patients is expected to experience it.
Previous Claims
According to Denmark’s Medicines Agency, there have been 32 reported cases of NAION linked to the use of Ozempic, Wegovy, or Rybelsus.
Novo Nordisk has previously said there is no “reasonable likelihood” that semaglutide directly causes NAION. The company confirmed to Danish media that the package inserts have been updated for EU sales.
The Question of Compensation
It is not yet clear how the EMA’s updated information will affect ongoing compensation claims in Denmark.
Patient Compensation is currently reviewing at least 27 claims from patients seeking compensation related to semaglutide use. The agency has waited for EMA’s decision before making further determinations.
Eligibility for Compensation
For most patients in Denmark, the new package insert is not expected to change much. Danish compensation rules allow for claims even when side effects are very rare and already listed in product information.
This differs from countries such as Germany and France, where being listed in the insert can affect eligibility for compensation.
Stay Alert when Using Medications
Novo Nordisk’s updates reflect the company’s commitment to keeping patients informed. Doctors and patients are advised to be aware of the very rare risk of eye problems while using semaglutide products.
Regular check-ups and reporting any vision changes remain important for anyone taking these medications.
This article is made and published by Anna Hartz, which may have used AI in the preparation
