What “off-label” use of a drug really is, and why you need to know about it

When your doctor prescribes a drug for you, you probably assume — and with good reason — that it is an FDA-approved treatment for your condition. That may or may not be the case. On average, one in five prescriptions are written for an “off-label” use of a drug. That means your doctor believes that the drug will help you even if it has not been approved specifically for your illness or symptoms. Off-label prescribing of drugs is legal and common, and can be beneficial for patients. For example, beta blockers (drugs approved to lower blood pressure and treat heart disease) can also help some people with migraines or anxiety. Tricyclic antidepressants are not FDA-approved to treat nerve pain, but many doctors consider them a good first-choice drug for this condition. When off-label use is backed by strong evidence that is submitted to the FDA, it can lead to FDA approval for that use. Most people know of botulinum toxin type A (or Botox) as a way to eliminate wrinkles, but it originally gained FDA approval for treating a number of different conditions, from excessive sweating to muscle spasms. While some off-label uses for drugs are well-studied and have been a part of routine medical practice for years, many other off-label uses have not. When a drug has not been tested for a specific condition or in a particular group of people, it could have unanticipated and hazardous side effects. For instance, doctors will prescribe antipsychotic drugs, such as haloperidol...
Source: New Harvard Health Information - Category: Consumer Health News Authors: Tags: Drugs and Supplements off-label use of a drug Source Type: news