Botox wins FDA approval to treat forehead wrinkles

botox forehead wrinkles photoPhoto © AdobeStock

Botox has won FDA approval for temporary treatment of moderate to severe forehead lines, making it the first neurotoxin approved for three facial treatment areas — forehead lines, crow’s feet lines and glabellar lines.

Allergan recognizes that forehead lines are a top area of concern for patients,” said David NicholsonChief Research and Development Officer at Allergan. “Our goal in pursuing a third indication for Botox Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes.”


Botox went into wide usage in the U.S. in 2002 when it won its first FDA approval to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines). In 2013, Botox Cosmetic was approved for the temporary improvement in the appearance of moderate to severe crow’s feet lines.

“As a physician, I’ve been using Botox Cosmetic since it was FDA approved in 2002,3 but for years my patients have also inquired about how to treat forehead lines,” said Dr. Steven Fagien, a surgeon in Boca Raton, Florida, and lead clinical trial investigator, in a news release. “I am proud to have worked closely with Allergan to establish criteria for proper patient selection, dosing and injection pattern for forehead line treatment and am pleased to see that the company is providing extensive injector training to help ensure optimal results.”

In clinical trials, Botox Cosmetic demonstrated efficacy compared with placebo in the reduction of the severity of forehead lines, as assessed by both the investigator and the subject at Day 30 (primary endpoint): 61% of subjects in study one and 46% of subjects in study two met the primary endpoint compared with placebo (0% in Study one and 1% in Study two). Similar response rates were seen across three treatments cycles.

Safety information

Botox Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing

Botox Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment.  If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive Botox Cosmetic if you: are allergic to any of its ingredients; had an allergic reaction to any other botulinum toxin product; have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions,

Tell your doctor about all your medical conditions, including: if you are or plan to become pregnant or breast feed.

Tell your doctor about all the medicines you take. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Botox  Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

The most common side effects include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, and swelling of your eyelids.

To report a side effect, please call Allergan at 1-800-433-8871.

About the Author

Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years. Most recently, he has reported extensively on health and consumer issues for ConsumerAffairs.com and FairfaxNews.com.