The U.S. Food and Drug Administration (FDA) has called for the removal of about 500 unapproved prescription drugs that are taken by mouth to treat colds, cough and allergies.
These drugs are unapproved because the FDA has not reviewed their safety, effectiveness or quality. However, many healthcare providers may be unaware that the drugs are unapproved because the labels do not explicitly state that they lack FDA approval.
In 1962, the federal government began requiring that the FDA review the safety and effectiveness of all new drugs before they enter the U.S. market. The FDA is also supposed to evaluate thousands of drugs that were already being sold.
In 2006, the FDA began its Unapproved Drugs Initiative to ensure that all drugs on the market have been evaluated and approved by the agency.
The FDA recommends that consumers contact their healthcare professionals if they are concerned that they may be taking unapproved medications.
For more information about integrative therapies for allergies or the common cold, please visit Natural Standard’s Comparative Effectiveness database.