Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them. Unapproved drugs have not been evaluated by the FDA for safety, effectiveness and quality, putting patients at greater risk when using these products compared to an FDA-approved drug.
“Removing these unapproved products from the market will reduce potential risks to consumers,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, according to an FDA news release. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products.”
Read the FDA news release about unapproved drugs.
Read more about patient safety:
– Healthcare Costs Soar for ED Patients Admitted for Adverse Drug Events
– AHRQ Highlights Successful Strategies for Increasing CRC Screening, Infection Prevention
– Some Hospitals Hesitant to Share Medical Errors Despite Push for Greater Transparency
