Parkway Medical Blog

What does off-label mean to you? Many medications and devices used in medicine are used “Off Label”. What it means is that the medication or device is FDA (Food and Drug Administration) approved for one purpose, and we use it for another purpose. It is legal and appropriate for physicians to use medication in this fashion, although not approved for other uses by the FDA. If something has no FDA approval, it is NOT legal to use anywhere!

Many years ago a heart medication was found to be useful in treating migraine headaches. The medication was used to treat hypertension, but those who took it found a decrease in headaches. So, doctors began using this medication and shortly thereafter, it was FDA approved for migraine treatments. Similarly, the product minoxidil (Rogaine) was used to treat hypertension and men noticed that their hair was growing. Some dermatologists began emptying the capsules to make a product that men could apply directly to the scalp, and hair grew. Thereafter, the company applied for and received FDA approval for hair growth, and the rest is history. It is now sold over the counter to treat male pattern baldness.

Many of the injections we perform at Parkway Medical Laser and Skin Centre are off label. Botox is FDA approved for use in the glabella (frown lines), yet it is used for forehead, eye’s, mouth, etc. Juvederm and Restylane are FDA approved for nasolabial folds, yet we use it for lips, chins, ears, and other areas. This does not mean we just said one day “I think I will use this somewhere else other than where it is approved.” There are conferences, studies, research, and other avenues where these things have been tried and have been successful. There is some science surrounding the use of injections.

Parkway wants you to know and understand that we and many others use these products in an off label fashion, but still within the legal limits and perfectly appropriate. Please ask about this if you have any questions.

This entry was posted on Tuesday, March 11th, 2008 at 9:52 pm and is filed under Family & Urgent Care. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.