sivukäyttö

Sivukäyttö, also known as off-label use, refers to the use of a medication, device, or treatment for a purpose other than that for which it has been approved by regulatory authorities. This practice is common in healthcare, where physicians may prescribe medications or use treatments based on their clinical judgment, even if the specific indication has not been formally approved. Off-label use can be driven by various factors, including the unavailability of an approved treatment, the severity of the condition, or the physician's belief that the treatment will be beneficial.

While off-label use can provide access to necessary treatments for patients, it also poses certain risks. Since the safety and efficacy of a treatment have not been rigorously tested for the off-label indication, there may be unknown side effects or reduced effectiveness. Additionally, off-label use can complicate insurance coverage and may lead to legal and ethical considerations, as it involves the use of a product in a manner not intended by the manufacturer.

Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), encourage the responsible use of medications and devices. They provide guidelines and resources to help healthcare professionals make informed decisions about off-label use, balancing the potential benefits with the risks involved. Patients and healthcare providers should engage in open communication to ensure that the benefits of off-label use outweigh the potential risks.