Sekundærindikasjoner

Sekundærindikasjoner refer to the use of a drug or treatment for a medical condition other than the one for which it was originally approved or developed. This often occurs when a medication demonstrates efficacy in treating a different ailment during clinical trials or through observational data collected after its initial release. For example, a drug initially developed to treat high blood pressure might later be found to be effective for certain heart rhythm disorders.

The process of identifying and establishing secondary indications involves further research, including preclinical studies and clinical trials, to confirm the drug's safety and effectiveness for the new use. Regulatory bodies then review this evidence before approving the drug for the secondary indication. This expansion of a drug's therapeutic uses can benefit patients by providing new treatment options for various conditions, potentially utilizing established safety profiles.

Physicians may also prescribe drugs off-label for secondary indications if they believe, based on their clinical judgment and available evidence, that the treatment will benefit the patient, even if it has not yet received formal regulatory approval for that specific use. This practice is common in medicine but carries inherent responsibilities for both the prescriber and the patient regarding informed consent and monitoring.