On January 9, 2013 the 10-month court injunction on Botox competitor Xeomin expired. Simon Ourian, M.D. of Epione Beverly Hills says that competition is good for the industry.
Xeomin Joins Botox and Dysport on the Market
“I don’t see how this can be anything but a good thing for consumers, ” opines Dr. Ourian, Medical Director of Epione Beverly Hills. “First there was Botox, then Dysport and now Xeomin, each with certain distinct attributes. This can only enable me to do a better job of serving the needs of my patients.”
Xeomin Injunction Expires
The injunction, issued by a U.S. District Judge on March 9, 2012, prevented Merz USA from doing a full commercial launch of Xeomin, the wrinkle-busting drug it developed to compete against market leader Allergan’s Botox. The judge concluded that several salespeople hired away from Allergan by Merz took confidential client information and market research when they left.
Six-Point Botox checklist
“Regardless of which treatment option you choose, consumers need to be smart and safe about the doctor they choose, ” says Dr. Ourian. “That why I recently created a six-point Botox checklist.”
- It’s important to know who is going to do the actual treatment. Will it be a physician or an RN. Do your research and ask friends and family for referrals.
- In California only a physician can conduct the examination and consultation required before a prescription for Botox, Dysport or Xeomin is issued.
- These are medical treatments and should only be done in a medical office setting.
- Make certain you understand the post-treatment instructions.
- Confirm that whatever product you choose to be injected with (Botox, Dysport or Xeomin) is the authentic product manufactured by Allergan, Medicis or Merz respectively. See below for more information about a recent U.S. Food & Drug Administration action.
- Don’t be afraid to ask questions.
FDA Warns U.S. Medical Practices About Unapproved Botox
The FDA warned over 350 medical practitioners about the potential dangers of the illegally manufactured Botox that have been delivered from spurious international suppliers. While the warning did not specify the Botulinum toxin as the only drug covered under the warning, the FDA has made it clear that the Botox consignments to these practices from a supplier named Canada Drugs held a high risk of contamination and did not meet FDA checks or standards for authenticity, purity, safe storage, secure transport and effectiveness. The agency also notified these medical facilities that these spurious drugs had the potential to have permanent and perhaps, fatal effects on patients.
“The FDA is very concerned that the Botox distributed by several of these international suppliers may be harmful to patients, as they may not be safe or effective.” says Thomas J. Christl the Acting Office Director of the FDA’s Office of Compliance.
He continued that the agency has recommended that each practitioner cease the distribution, use and administration of these compromised drug consignments. There is no assurance of the quality, potency, viability and safety of these drug consignments since the manufacturer does not meet the agency’s stringent guidelines for the manufacture, storage and distribution of Botox.
FDA Focus on Consumer Safety
The FDA continues its focus on safe, regulated medications to enhance the quality of healthcare in the U.S. The agency is committed to ensure that all medications distributed in the country are suitable for use with detailed information about their prescription and dosage. The FDA has also attached a list of medical practitioners to whom the warning has been sent.