The U.S. Food and Drug Administration today took action against
companies that manufacture, distribute, or market certain unapproved
prescription oral cough, cold, and allergy products. The affected
products cannot be legally marketed in the United States.
Unapproved prescription cough, cold, and allergy drug products have not
been evaluated by the FDA for safety, effectiveness, and quality. People
may be at greater risk when using these products than when using
FDA-approved prescription drugs or drugs that are appropriately marketed
over-the-counter (OTC).
Many health care providers are unaware of the unapproved status of drugs
and have continued to unknowingly prescribe them because the drugs’
labels do not disclose that they lack FDA approval.
“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. “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.”
Companies that have previously listed products subject to today’s action
with FDA are expected to stop manufacturing them within 90 days and
stop shipping the products within 180 days. Companies that have not
previously listed products subject to today’s action with FDA are
expected to stop manufacturing and shipping their products immediately.
Given that so many cough, cold, and allergy drug products exist that are
FDA-approved prescription products or are appropriately marketed OTC,
taking an unapproved prescription product is an unnecessary risk.
Consumers who believe they are taking an unapproved prescription cough,
cold, or allergy product should contact their health care provider to
discuss alternatives.
This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative,
which began in June 2006. The initiative is the agency’s risk-based
enforcement approach to efficiently and rationally bring all unapproved
new drugs into the approval process. One of the goals of the initiative
is to reduce consumer exposure to drugs that are not proven safe,
effective, and of high quality.
Source: U.S. Food & Drug Administration
Much of the well-advertised medicines need to be checked by FDA.