New Indication for Botox Cosmetic
October 2, 2017 – The U.S. FDA has approved Botox® Cosmetic (onabotulinumtoxinA) injection, manufactured by Allergan, for a new indication to smooth moderate-to-severe horizontal lines across the forehead. The drug already holds approval to temporarily smooth lines at the corners of the eyes (crows feet), as well as vertical lines on the forehead between the eyebrows (glabellar lines).
Recommended dosing for the new indication is 0.1mL of Botox Cosmetic injected into five sites on the forehead by a healthcare professional. This should be done at the same time that five 0.1mL doses are injected to smooth glabellar lines.
Like other botulinum products, Botox Cosmetic has a black box warning that its effects may spread beyond the injection site, and that is has the potential to cause severe and potentially fatal side effects, including difficulty breathing and/or swallowing. Adverse effects may not become apparent until hours or weeks after the administration of botulinum products.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.