The Surgeon Minute

Authorities Seize a New Skin Care Drug Being Marketed Without Approval From the FDA

Authorities Seize a New Skin Care Drug Being Marketed Without Approval From the FDA

Authorities seize a new skin care drug being marketed without approval from the Food and Drug Administration. The FDA says U.S. Marshalls seized the drug from Crescendo Therapeutics LLC, a California based company that has continued to market the unapproved drug despite repeated warnings. The prescription drug, HybriSil, was being marketed as a topical gel, to treat scars and skin disorders.

Evidently, this is not the first time the company has had problems with the government agency.

  • In April 2011 the FDA discovered the drug company marketing the cream without FDA approval.
  • Seven months later, in November 2011, The FDA warned Crescendo Therapeutics, they could not continue to market HybriSil as ‘safe and effective’.
  • On January 3, 2012, Crescendo submitted an application to the FDA to market HybriSil for investigational use only.
  • However, another inspection in January 20l2 revealed that Crescendo continued to distribute HybriSil for non-investigational purposes.

Patients should discontinue use of HybriSil

HybrisilAs of yet, the FDA has not received any reports of adverse reactions from the drug. If you happen to be a patient who is using HybriSil, you should discontinue use immediately. Dr. Dan Del Vecchio, a board certified plastic surgeon in says, “there are alternative drugs on the market that are FDA approved and work well on scars and skin disorders.”   Another board certified plastic surgeon from Dallas, William P. Adams Jr MD, adds “The  scientifically proven scar therapy products are silicone gel sheets and topical silicone gels.  It is unfortunate that  this company chose to promote an non-FDA approved  product to surgeons as well as recommended primary use of a steroid for scar therapy, a practice that few  would agree with.”  For more information on approved topical scar therapy gels containing steroid see a recent PSC mediawire from March 2012.

How does the consumer know if a drug is safe?

Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs says “The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”

Dr. Peter Fodor, a board certified plastic surgeon in Beverly Hills says, “It is best for patients, considering today’s ease of gathering information to do some research.  As a source they can talk to pharmacists, check the internet and of course, talk to the physician who prescribed or suggested it.”

“The best way to feel assured if a drug is safe is to have it prescribed by a physician you trust,” says Del Vecchio. He says another benchmark would be to see how long the drug has been on the market and a third way is to look on-line to see if the FDA has issued any warning letters that are related to the drug.

The FDA advises the public and physicians to report any problems from the drug by calling 800-FDA-1088, or by logging on to: www.fda.gov/medwatch/report.htm.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

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