Off Label

Off Label is a term used to describe use of a medicine for uses not approved by the Food and Drug Administration (FDA) and not recommended by the pharmaceutical company. It refers to any of the following:

• Using unapproved dosing
• Using a medicine for an unapproved conditions
• Prescribing a medicine for an unapproved age group

Despite contrary belief, prescribing medications off label is perfectly legal in the United States.  This is a good thing because it allows doctors a right to use a medicine to its full potential and this greatly benefits patients.

A good example is a medicine we respiratory therapists use on a regular basis.  The recommendation is for Albuterol to be prescribed for use every 4-6 hours as needed for shortness of breath.  The medicine is not recommended for children under the age of two because there have been no studies using Albuterol for this age group.

To gain approval by the FDA a pharmaceutical company must perform studies and make recommendations for use of a medicine.  This is basically for liability purposes.  A doctor may prescribe the medicine for other uses and doses, yet by making such recommendations, the pharmaceutical company is not held liable for off label uses of their medication.

Most doctors know there are asthmatics and COPD patients who need to use Albuterol more often than the recommended dose.  I can tell you first hand Albuterol is very safe when used above the recommended frequency.  When I used to have hardluck asthma I used it as needed with the approval of my doctor so I didn't have to go to the ER every day.

Likewise, Albuterol is used on pediatric patients with good results.  It is also used in emergency rooms at continuous doses to help asthmatics breathe better.  Clinical studies -- and personal experience of many doctors, nurses and RTs who work in ERs -- show that Albuterol used in this off label fashion works just as well as epinephrine without the side effects.

Many cancer medicines are used off label.  Even morphine can be used off label.  Pulmicort was recently prescribed by one doctor for a patient to squirt in his nose to help with nasal inflammation.  This is an off label use of the medicine and worthy of a trial by that patient.  

I guess you can say that using a medicine off label is an option when all other options for treating a disease have been exhausted.  It's done to the benefit not just of the patient, but all other patients who may need such a medicine for an off-label indication in the future.

Off-label use of a medicine is a good method of allowing the doctor and patient decide what's best for the patient as opposed to the government.