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Wednesday, March 7, 2012

Off Label

Off-Label is a term used to describe the 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 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.

Albuterol is a good example. It's approved for use every 4-6 hours for asthma. However, it is often used in much higher doses in emergency rooms. Some asthmatics use it more often at home, and this is okay.

Albuterol also is not approved for use in pediatrics. This is because most pharmaceutical companies don't do studies on children under the age of 12. Still, doctors are not going to deny these patients a medicine they know will help them.

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.  Once FDA approved, a doctor may legally prescribe the medicine at any dose and for any other diagnoses.  But, by making such recommendations, the pharmaceutical company is not held liable for off-label uses of their medication.

I can give a couple other examples. Both Advair and Breo were both initially approved for asthma. They were both used for COPD long before this was FDA approved. Spiriva was FDA approved for COPD. But, some doctors prescribe it for asthma. This is okay. It's legal.

Off-Label has its benefits. 

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 of the patient by allowing another option to be tried. But, it also benefits patients who may need such a medicine for an off-label indication in the future. 

It's also a neat way for doctors to decide what's best for their patients, rather than pharmaceutical companies. If there's a medicine approved for COPD, they can decide if it's worth trying on their asthmatic patients. 

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