On March 2, 2011 the U.S. Food and Drug Administration (FDA) announced that they are requiring the removal of nearly 500 unapproved prescription cold, oral cough and allergy products from the market. Here are a few points of interest for you and your patients. It is important to make a distinction between these unapproved drugs and the individual components within the drugs. Many of the components can be obtained over-the-counter or by prescription and are approved by the FDA. However, the listed drugs for removal have not proven safe and effective by approved FDA studies.
Furthermore, some combination of the components contained in these drugs could result in adverse effects. The FDA also has concerns regarding the manufacturing processes for unapproved new drugs and changes in the formulations of these products. Finally, FDA has specific safety concerns about the products covered by this notice that are marketed as extended-release products. The removed drugs are in some cases untested combinations, many with familiar names. Many of the mostly liquid medication combinations have not been studied. In addition, the package insert language has not been approved and this can result in the use of these medications in inappropriate populations and for unproven indications.
This FDA action will not happen right away. 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.
These links offer detailed information:
• FDA News Release
• FDA Q&As
Although some allergy medications may no longer be available, many effective and approved medications remain that can be prescribed to help allergy patients find relief.
