May lead to severe and permanent vision loss
In the study it was found that the use of Ozempik more than doubles the chance of developing a non-inflammatory infarction of the optic nerve head – a disturbance in the blood flow to the optic nerve which manifests itself in a sudden decrease in vision. Prof. Grausland explains that this is a condition that may lead to severe and permanent vision loss.
It also emerged from the findings that since the release of the drug “Ozmpic” on the market in 2018, there has been an approximately two-fold increase in the number of cases of patients suffering from such a medical condition in the eyes in Denmark. Prof. Grosland points out that according to the study, the number of people who contracted the disease is lower than that found in the American study earlier this year, but it is still double the number of cases. The study was recently accepted into a medical journal, and is expected to be published soon.
The second study, led by Anton Potgaard, professor of pharmacoepidemiology and clinical pharmacy in the Department of Public Health at the University of Southern Denmark, included data from both Denmark and Norway, and was carried out in collaboration with the Norwegian Institute of Public Health. The study examined data from 44,517 Danish diabetic patients who took Ozampic between the years 2018-2024, and 16,860 Norwegian diabetic patients who received the drug between 2018-2022.
This study also found that type 2 diabetes patients who use the drug are almost three times more likely to develop an optic nerve infarct, compared to those who do not take the drug. This study is currently undergoing peer review.
The researchers emphasize that they do not intend to advise diabetics to stop their treatment, since without treatment, diabetes can lead to various complications, including in the eyes, and some of them are much more common than optic nerve head infarction. The researchers add that such a serious and rare medical condition is no more serious than the side effects of many other drugs that the public uses. According to Prof. Grossland, they are full of hope that the new findings can be used by doctors and patients to discuss the advantages and disadvantages of Ozampic treatment.
The Danish Medicines Agency says that during the past six months, they have examined the possibility that optic nerve infarction is a possible negative reaction to semaglutide – the active ingredient in Ozmepic. According to them, as of the beginning of December, the agency received a total of 19 reports of patients suffering from optic nerve head infarction.
They add that so far the data has been collected both from reports received and from previous studies, and they have not been significant enough to indicate a possible connection between the drug and the symptoms. However, “the findings of the new studies carried out at the University of Southern Denmark, strengthen the suspicion, and may constitute important information that the European Committee for the Safety of Medicines must evaluate, in order to find out if there is indeed a connection between the drug and the medical condition,” the agency said in a statement.
The head of the department at the agency also stated that this is a rare situation. Moreover, according to her, it is currently unclear whether Ozampic is the cause of the reported increase in optic nerve head infarction cases, or whether other factors have led to this condition among diabetic patients.
The response of the medicine manufacturer Novo Nordisk: “Patient safety is a top priority for Novo Nordisk. The company carefully examines any report of side effects from the use of its drugs. After a thorough examination of studies and an internal review of safety, the company believes that the risk-benefit profile of the treatment remains stable and unchanged. Anterior ischemic event of a nerve The evidence (NAION) is not defined as a side effect according to the labels of the approved preparations, as part of a comprehensive examination of clinical studies, incl A professional evaluation by ophthalmologists identified a small number of NAION cases, and no different rate was found from the population in the control groups.”