Botox is consistently the most popular and well-known cosmetic treatment in the United States, but it didn’t start off that way. Back when the drug was first approved decades ago, it was used to treat eye and eyelid problems. Today, it is approved by the Food and Drug Administration (FDA) for both cosmetic and medical purposes. But Botox is an extremely versatile drug that can be helpful for more than just its approved uses. This is called “off-label” use. But what does “off-label” mean, and is it safe?
Botox’s Approved Uses
Because Botox has such a long history of success, the FDA has approved it for several uses. Medically, it has been approved since 1989 to treat crossed eyes and eyelid tics. Cosmetically, it is approved to soften lines and wrinkles between the eyes (frown lines) and at the corners of the eyes (crow’s feet). These uses have been studied extensively and were given FDA approval after a long process of clinical trials.
Botox works by using a safe form of botulinum toxin to limit muscle movements. This affects “dynamic” wrinkles, which are caused by repetitive facial movements such as smiling, frowning, or even puckering the lips. Although it is not a permanent treatment, Botox is extremely popular because it is so effective in treating wrinkles. But it also has a lot of off-label uses patients rely on.
What Does Off-Label Mean? Is it Safe?
Off-label Botox doesn’t mean generic Botox or a lower-quality product, it’s about the approved uses. As we’ve established, off-label just means that the drug hasn’t been approved for the specific purpose by the FDA. But doctors use drugs like Botox off-label all the time safely and effectively. Just because a drug hasn’t been through the rigorous process to add approved uses doesn’t mean it’s dangerous. “Off-label” sounds sneaky to many patients, but it’s actually a very common practice, especially for drugs like Botox with an established track record of safety.
Millions of patients receive Botox with no serious complications. So if your plastic surgeon suggests using Botox for something other than crow’s feet or frown lines, don’t be concerned. It’s a common practice. In fact, Botox was only recently approved for treating frown lines. Before that, these treatments were off-label too!
Is Off-Label Botox Use Legal?
If your plastic surgeon has suggested off-label Botox, don’t worry. Off-label use is legal and common. It relies on the good judgment and experience of doctors. An experienced plastic surgeon knows how to inject Botox to best serve each person’s needs. Sometimes, that just means using the drug for its FDA-approved purposes. Sometimes, it’s off-label. The bottom line is that reputable plastic surgeons customize the treatment to the patient, but they never compromise patient safety.
Off-Label Uses for Botox
So what are some of the common uses for off-label Botox? Most often, dynamic wrinkles that don’t fall into the “approved” category as defined by the FDA. That might include those horizontal forehead lines that form from furrowing the brow or lines near the lips.
Other off-label Botox uses are for medical conditions. Botox can reduce excessive sweating, especially in the armpits and hands for people who have chronic issues. It is also helpful for people who suffer from migraines on a regular basis.
Choose Your Plastic Surgeon Wisely
Just because it’s generally safe to use Botox off-label, that doesn’t mean that all medical professionals can safely administer the treatments. It’s important to choose a board-certified plastic surgeon with years of experience to perform all of your cosmetic treatments. These doctors have in-depth knowledge of facial anatomy and aesthetics and can help patients get the natural-looking results they want while maintaining a high level of safety.
Dr. Edward Buckingham is a board-certified facial plastic surgeon with a long history of helping patients achieve beautiful, natural-looking results. He is known for his skill with injectables and minimally-invasive surgical procedures. He takes pride in tailoring each patient’s Botox treatments to meet their specific needs. To schedule a consultation with Dr. Buckingham, call Buckingham Center in Austin, TX at 512.401.2500 or fill out our online contact form.