Unapproved cold, cough and allergy products being removed from the market.

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

• FDA List of Unapproved Prescription Cough, Cold, and Allergy Products Consumer Update

• FDA Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval

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.

Spring Allergy Tips

The arrival of spring, with warmer weather and budding trees and flowers, is a welcome event for most people. For the 35 million Americans who suffer from allergic rhinitis, spring also means the return of coughing, sniffling, sneezing, and watering eyes. Did you know:

·       Approximately 16.7 million office visits to healthcare providers are attributed to allergic rhinitis each year

·       Increased absenteeism and reduced productivity cost U.S. companies more than $250 million each year

·       Allergies can lead to other chronic conditions, such as asthma, sinusitis or otitis media (an ear condition)

As trees, grass and flowers begin budding in the spring, the amount of pollen in the air increases, leading to  more severe symptoms for allergy sufferers.  Fortunately, they can take steps that will decrease their allergy symptoms:

·       Take a shower after spending time outdoors to remove pollen that may be on your skin and hair

·       Avoid hanging sheets or clothing out to dry, pollen and molds collect on them

·       Take medications as prescribed in the recommended dosage. Do not take more medication to alleviate severe symptoms. If the medicine does not appear to be helping, contact your physician

Spring Allergies

Spring is approaching fast and allergy season is rolling in. Stay tuned for tips on how to minimize your symptoms.