Imprimis Pharmaceuticals Inc. recently released a statement after the MedWatch notification put forth by the U.S. Food and Drug Administration.
"Imprimis is 100 percent dedicated to patient safety and regulatory compliance,” Imprimis CEO Mark Baum said in a statement. “Imprimis has been successful because we place patient safety and compassion for those we serve above all else. Imprimis facilities are regularly inspected by state and federal officials, including the FDA, and our distinguished quality team looks to all regulators as partners in protecting patients, which is critical for the long-term success of our business."
Baum noted that his company, while saddened by the tragic events referenced in the notice, believes the events happened because of allergic or hypersensitivity reactions. Baum claims that the product never should have been administered to the patients.
“We have safely dispensed the referenced curcumin emulsion over 30,000 times without incident,” Baum said. “The production and safe dispensing of our products (or any drug product) necessitates compliance with the law by the prescribing doctor. Related to this, there are additional facts that must be disclosed to clarify and more completely and accurately inform the public of Imprimis' connection to these cases."