Questions & Answers for Consumers about Unapproved Drugs

While most prescription drugs marketed in the U.S. have been reviewed and approved as required by FDA, some unapproved prescription drugs are marketed by companies, prescribed by physicians, and taken by patients. Some unapproved drugs, such as phenobarbital, used to control seizures, are very important therapies in the treatment of significant medical conditions and appear to have benefits for patients, so patients should not stop taking an unapproved drug without talking to their doctor first to determine their best treatment options. However, being unapproved means a drug’s safety, effectiveness, manufacturing, and labeling have not been specifically reviewed by FDA. Click the link above for more information on this topic from the U.S. Food and Drug Administration.