top of page

DRUGWATCH: Off-Label Drug Use: What You Need to Know

Off-label drug use refers to the use of a medication in a way that has not been approved by the Food and Drug Administration. This can include using a drug for an unapproved indication, age group, dosage, or route of administration.

Off-label prescribing is legal, but the efficacy and safety of the medication have not been reviewed by the FDA. Off-label use is common and can be beneficial to patients, but it can also increase the risk of harm and liability for providers.


Sildenafil :

FDA-approved use : treating erectile dysfunction and pulmonary arterial hypertension

Off-label use: treating altitude sickness and Raynaud’s phenomenon


If a patient does not have access to a particular FDA-approved drug, a doctor may prescribe a drug off-label. Drugs in the US are approved and legalized by the FDA. In order to gain FDA approval, drug companies must submit certain information to the agency.


Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems who is with Drugwatch and has given a detailed explanation of Why Doctors Prescribe Drugs Off-Label with fast facts that all healthcare professionals need to be aware of.


Read and understand more about Off-Label Drug Use from the Drugwatch site, by clicking this LINK.

コメント


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page