BOTOX Likely to Get OK to Fight Wrinkles

BOTOX, or botulinum toxin, is expected to receive Food and Drug Administration approval for broader use in facial cosmetic applications in the near future.

This comes after a long history of its off-label or non-FDA-approved use for this same purpose.

Since the mid-1990s, BOTOX has been used to treat facial wrinkles, or rhytids, without approval from the FDA.

Up until now, BOTOX's designated use, according to the FDA, has been to treat patients with complex neuromuscular disorders that cause muscles to be hyperactive or spastic. Some of these disorders include blepharospasm, a tic-like movement of the eyelids, and laryngeal dystonia, a disorder of the vocal cords that causes an erratic vocal quality with breaks and sudden changes in pitch).

In these cases, BOTOX acts to block the release of a chemical, acetylcholine, that is responsible for signaling the muscles to move. By blocking the nerve impulse to the muscle the muscle is weakened.

Cosmetic Use

More recently, new applications for BOTOX in facial plastic surgery have developed. The FDA has not officially approved these applications, but they are quite popular.

The most common current usage is for hyperfunctioning facial muscles that create lines of animation or "wrinkles."

Examples of such lines are the horizontal creases that form on the forehead when we raise our eyebrows. The "crow's feet" lines that occur as we age that radiate from the outer edge of the eyes are also a product of the muscle acting on the skin over time.

All of this combines to create a face that appears older and wrinkled. To combat this, BOTOX is used to selectively weaken those specific groups of muscles responsible for the unwanted lines or wrinkles.

Ease of Use: It is injected in small doses directly into the muscles. This is performed in a doctor's office using a very small needle. The only pain experienced is during the injection of the BOTOX. The BOTOX itself does not burn or sting.

Onset of Action: The effects of BOTOX can be seen beginning at approximately two days and are maximal by three to four days.

Duration of Action: By three months, most patients will have minimal residual effect of the BOTOX, and for this reason most patients are placed on a three-month regimen for maintenance.

Benefits: The benefits of BOTOX are tremendous in combating the signs of aging that are associated with muscle action such as the crow's feet, forehead and glabellar (the area between the eyebrows just above the nose). When administered appropriately, the results are a smooth forehead and more youthful appearing eyes.

Disadvantages and Risks: The amount of BOTOX administered for facial wrinkles is small enough that systemic reactions should not occur. Allergic reactions to the components of the BOTOX are possible. The effect of BOTOX is not permanent and so re-injection every three months is necessary. Any undesired effect in a particular area will persist for three months. There is no way to reverse its effect. For this reason, BOTOX should be administered by a physician who has particular expertise in its use for facial wrinkles.

The uses of BOTOX continue to expand and it has shown some benefit in migraine and tension headaches, as well as hyperhidrosis (sweaty palms). By far the most popular and widespread use of BOTOX today is for its rejuvenative effect on the face. By erasing the lines of age, some of the youthful appearance of earlier days can be restored.

Dr. Gregory H. Branham is an associate professor and director of facial plastic surgery at the St. Louis University School of Medicine.

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