"What" Series

What is the meaning of off-label use?

22 March 2024
2 min read

Off-label use refers to the practice of prescribing or using a medication for a condition, age group, or dosage that has not been officially approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This type of usage is based on clinical experience or research that may suggest the medication's effectiveness for a particular purpose, even though it has not gone through the full regulatory process for that specific application.

The key points about off-label use are:

1.Unapproved Indications: The medication has not been tested and approved by regulatory bodies for the condition being treated.

2.Legal and Ethical Considerations: While off-label use is legal in many countries, it may raise ethical questions about the balance between patient care and the need for rigorous testing to ensure safety and efficacy.

3.Insurance Coverage: Insurance companies may not cover the costs of medications used off-label, as they are not approved treatments for the condition in question.

4.Research and Evidence: Off-label use may be supported by limited or preliminary research, and healthcare providers may rely on anecdotal evidence, case studies, or small clinical trials.

5.Professional Judgment: Physicians may use their professional judgment to prescribe medications off-label when there are no approved treatment options available, or when they believe the potential benefits outweigh the risks.

6.Patient Informed Consent: It is important for healthcare providers to inform patients about off-label use, including the potential risks and the lack of formal approval for the treatment.

Off-label use is a complex area of medical practice that requires careful consideration of the available evidence, patient needs, and the potential for harm or benefit. It is a topic of ongoing debate in the medical community, with some advocating for more flexibility in treatment options and others emphasizing the importance of strict regulatory oversight to ensure patient safety.

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Actinium-Based PSMA Radioconjugate Deal Targets Prostate Cancer Treatment and Development
Latest Hotspot
3 min read
Actinium-Based PSMA Radioconjugate Deal Targets Prostate Cancer Treatment and Development
22 March 2024
The deal encompasses a clinical-phase actinium radioconjugate aimed at PSMA to combat prostate cancer, a collection of radioconjugate products in development, and cutting-edge research, development, and production infrastructure.
Read →
How to Effectively Search for Progesterone on Synapse
Drug Insights
2 min read
How to Effectively Search for Progesterone on Synapse
22 March 2024
Progesterone, a diminutive molecule drug, acts as a modulator of the progesterone receptor (PR), exhibiting a broad spectrum of active indications.
Read →
Lynparza and Imfinzi Surpass Chemotherapy in Advanced Endometrial Cancer Response
Latest Hotspot
3 min read
Lynparza and Imfinzi Surpass Chemotherapy in Advanced Endometrial Cancer Response
22 March 2024
Lynparza and Imfinzi substantially increased the average response time, outperforming chemotherapy, in providing clinical advantages for individuals with advanced or relapsed endometrial cancer that shows proficient DNA mismatch repair.
Read →
What Is a Blockbuster Drug?
"What" Series
2 min read
What Is a Blockbuster Drug?
22 March 2024
A "blockbuster drug" is a term used in the pharmaceutical industry to describe a medication that is extremely successful in the market, generating significant sales and revenue.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.