Are off-label uses of Restylane injection safe?

How do you know if an injectable (like Restylane injections) is safe for a use that it is not specifically approved for -- like injecting the back of the hands for example?

4 answers to “Are off-label uses of Restylane...”

A: Off label uses similar to approved use are safe under certain circumstances

Mark A. Codner, MD

Off label uses that are similar to the approved use, and that are commonly practiced among physicians are generally safe, so long as all the proper procedures are followed, including: Your doctor is qualified It is an FDA approved brand Safety practices including sterilization and patient education and risk... more

A: Off-label use of Restylane

Steven Wallach, MD

Off-label use refers to doctors using medications that are FDA approved for one type of treatment and use it for another non-approved treatment.  As to the use of restylane on the hands, some doctors inject these products and other fillers to improve the aged appearance.  I would use a doctor... more

A: Ask specific questions about off label treatments

Jeffrey M. Kenkel, MD

Once a device is FDA approved it may be used "off label" by a physician. This means it may not be as thoroughly studied for that specific application through scientific methods as the original FDA approval. Because of that, we recommend that you thoroughly explore the off label use with your... more

A: Restylane and Injectable Fillers - Off- Label Use: Is It Safe?

Arnold W. Klein, MD

The short answer to your question is that you don't know if it is safe. Off-label means that the proposed use is not approved by the FDA. Off-label is perfectly legal, but as a consumer, you do not know if it is safe and effective. When medical corporations present a drug or device (Restylane) to the FDA for... more

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