Off-label use of Botox can benefit many

Q. I just heard that Botox cosmetics became approved by the federal Food & Drug Administration for treating crow’s feet and lateral wrinkles. I have been getting Botox now for the last five years for these areas. Does this mean my doctor has been doing something illegal?

No. I have been injecting Botox for crow’s feet for the past 19 years and have had no problem with it. My patients have benefited from its use for many years.

Physicians use many drugs that are FDA-approved for specific purposes. They will, however, use the same drug for different purposes from what the agency originally approved it. This is called “off-label’’ use.

While FDA approval is necessary to use a drug on patients, off-label use is commonly done by physicians when, after using the drug, an improved condition results. Many uses for Botox have come about because of this, including helping people with migraines and minimizing excessive sweating.

While at first it would seem that physicians are being cavalier using drugs off label, many drugs have become FDA-approved as a result of this use and further research.

FDA approval is a long and tedious procedure. This procedure has its benefits as it has saved many Americans from using drugs that have caused havoc around the world. Thalidomide and its resulting birth defects is one such drug.

One problem with using drugs with strict FDA labeling, however, is that some beneficial effects may not be realized for many years as the FDA requires stringent studies that may take a long time and cost a lot of money. Using a drug off label may hasten the approval process when the drug company sees there are benefits beyond the original use, which means more profits for it.

I’m happy to hear that the FDA approved Botox for crow’s feet, as it confirms what doctors have known for many years. The FDA approval makes patients who otherwise might be concerned about its safety feel more comfortable. Of all the drugs I have used over the years, Botox is certainly one of the safest when used by properly trained physicians.

Dr. Carlos Wolf is a partner at Email your questions to: