Novo Nordisk provides a specific response to the research paper on the side effect of semaglutide on erectile dysfunction (ED)
On June 4th, Novo Nordisk finally responded to research suggesting that semaglutide may be associated with male erectile dysfunction. They stated that according to the approved US prescription information (PI) or EU product characteristics summary (SmPC), sexual dysfunction is not a semaglutide (Wegovy)side effect .
Novo Nordisk was not involved in the execution or analysis of the study. The analysis results did not provide sufficient information on the dosage form and dosage (at the start and end of treatment) or treatment duration of Semaglutide. Therefore, it cannot be confirmed whether the dose of semaglutide evaluated in this study has been studied or approved for long-term weight management.
The PDE5 inhibitors (type 5 phosphodiesterase inhibitors) mentioned in the research paper are not only used to treat erectile dysfunction, but also to treat benign prostatic hyperplasia. Novotech, Wegovy, and Novotech have been fully validated in clinical research and development projects, as well as large-scale real-world data studies, with a cumulative usage experience of over 11 million patients exposed to years.
Ensuring patient safety has always been its top priority. Novo Nordisk will continue to monitor adverse drug reactions, including sexual dysfunction, through routine drug vigilance. Novo Nordisk works closely with relevant institutions to ensure patient safety and provide sufficient information for healthcare professionals.
Before using Semaglutide, it is best to consider the advice of regulatory agencies and medical professionals
Although the side effects of ED remain to be discussed, the drug has been approved for use in type 2 diabetes in China. The instructions have detailed the adverse reactions of the immune system, nervous system, gastrointestinal system and other aspects. When the weight loss version of Semaglutide was approved in the United States, regulatory authorities specifically mentioned that the contraindications for the drug include patients with a history of medullary thyroid cancer or family history, as well as patients with type 2 multiple endocrine neoplasia.
Regarding thyroid risk, Novo Nordisk has responded that safety data from trials and post market monitoring did not reveal a causal relationship between the drug and thyroid cancer. As for the risk of suicide, in January 2024, the US Food and Drug Administration (FDA) officially said that preliminary evidence showed that diet and diabetes drug smeglutide were not associated with the increase of suicidal thoughts.
Semaglutide can improve male sexual function
In March 2024, a paper published by Andrology also concluded that semaglutide can improve male sexual function. This is a retrospective study, which selects the group of patients with diabetes. All patients in the experiment confirmed erectile dysfunction (IIEF5 score 13 to 19) before treatment. After 12 months of treatment, the research results showed that the International Erectile Function Index (IIEF5) score of the final experimental group (metformin+GLP-1) was higher than that of the control group (metformin) (2.74 ± 0.53, P<0.001).
