FDA List of Unapproved Prescription Cough, Cold, and Allergy Products

On March 2, 2011, the FDA announced that certain unapproved prescription cough, cold, and allergy products will be removed from the market.  Here is the official notice in the Federal Register.  There are three general categories of products: "products in extended release form, products that contain tannates salts (e.g., phenylephrine tannate) as active ingredients, and certain immediate release products.  Today’s action does not affect OTC cough, cold, and allergy products."  It is clearest to simply quote the FDA website page.  The list of over 500 prescription medications is here.  If you are confused and unsure about your prescription, check this list.  Here is the FDA's relevant Q&A page.  Their rationale is review again here.

I think this will affect many of my patients.  Why?  There was always a medical need for these medications .  Here, things getting very muddled, for multiple potential reasons.  Some times, medications on this list were selected by patients because there was a desire to have a prescription medication, not over-the-counter, with few choices being available on their insurance company's formulary, thinking that other options have been tried already.  Sometimes, the pharmacy switched patients over.  Sometimes, this medication was the least inexpensive option available.  Sometimes, the medication works very effectively, but now the FDA has questions about the quality of the manufacturing process.
 

What is the time line?  Manufacture must stop within 90 days of 3/2/11.  Shipping of meds must stop by 180 days.  So supplies won't be affected for probably 270 days.  I already feel the ripples.  Drug reps have come to me to clarify the situation.  (Thank you, I'm on it already.)  Many are worried about their jobs.  Pharmacies and their suppliers right now are trying to reduce their inventories.  Some patients are already at the fork in the road and being pressed to discuss alternatives.

I promise to work with my patients, if affected, to find a safe, effective, and cost-effective alternative as soon as possible.  I predict many patients will end up buying the few remaining OTC combination products for relief.  There are very, very few prescription medication alternatives.

Updated 3/31/11 NK