Unapproved prescription cough, cold, allergy meds pulled

The FDA ordered the market removal of a large number of prescription oral cough, cold, and allergy products last week.

The drugs had not been approved by the agency, but because the drugs' labels do not disclose that they lack FDA approval, clinicians may have been unaware of the unapproved status of the drugs and continued to prescribe them, an FDA news release said. Over the past century, the laws outlining the requirements for drug approval have changed. In part as a result of these changes, many of the products targeted by this FDA action have been marketed without being approved under the current legal requirements.

There are numerous potential concerns about these products, FDA officials said. Some may contain risky combinations of ingredients, while others—marketed as timed-release—may release active ingredients too slowly, too quickly, or inconsistently. The agency has also received reports that some products have names that look or sound similar to other products. The FDA therefore concluded that the products pose unnecessary risk to consumers, especially given that approved prescription drugs and over-the-counter drugs that meet FDA standards are available to treat the same symptoms.

The companies that distribute these drugs have been ordered to stop production within 90 days and distribution within 180 days. A full list of the affected products is available online.