When should Restylane not be used?
Restylane ® should not be used in patients who have: • severe allergies marked by a history of anaphylaxis ( hypersensitivity to the ingestion or injection of a drug or protein) • multiple severe allergies • severe allergies to gram-positive bacterial proteins Restylane should not be used for: • breast augmentation • implantation into bone tendon, ligament, or muscle, or implantation into blood vessels, because it may obstruct blood flow. Additional information: Summary of Safety and Effectiveness and labeling will be available at: www.FDA.gov – CDRH Restylane You should also check the United States Food and Drug Administration web site for the latest information. Put the word “Restylane” into the search box. Generic Name: non-animal stabilized hyaluronic acid (NASHA) injectable gel Approved: December 12, 2003 Company: Medicis Treatment for: Facial Wrinkles FDA Approval Letter for Restylane on PDF The U.S. Food and Drug Administration (FDA) has approved Restylane ®, an injectio
