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U.S. Department of Health and Human Services

Drugs

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Questions and Answers: FDA Intends to Remove Unapproved Prescription Cough, Cold, and Allergy Drug Products from the Market

On March 2, 2011, the U.S. Food and Drug Administration (FDA) announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the U.S. market. FDA is taking this action because these products have not been evaluated by the Agency to assure they meet today’s standards for safety, effectiveness, and quality.

There are many FDA-approved products available for the treatment of cough, cold, and allergy symptoms, thus the standard of care that patients receive should not be affected.
 
Q1: What are cough, cold, and allergy drug products?
Q2: What makes a prescription cough, cold, and allergy drug product unapproved?
Q3: Are unapproved prescription cough, cold, and allergy drug products safe?
Q4: Is there a list of the unapproved prescription cough, cold, and allergy drug products that are being removed from the market?
Q5: What should consumers do if they currently take an unapproved prescription cough, cold, or allergy drug product?
Q6: How can a consumer know if the drug they are using for cough, cold, or allergy symptoms is FDA-approved?
Q7: What should healthcare professionals do if their patients currently take unapproved prescription cough, cold, and allergy drug products?
Q8: What should manufacturers do if they currently market unapproved prescription cough, cold, and allergy drug products?
Q9: Why are unapproved prescription cough, cold, and allergy drug products on the market and prescribed by healthcare professionals?
Q10: Are there any specific safety concerns related to the unapproved prescription cough, cold, and allergy drug products covered in this action that are labeled for children?
 

 
 
Q1: What are cough, cold, and allergy drug products?
 
A: Cough, cold, and allergy drug products are used to relieve symptoms associated with the common cold or upper respiratory allergies. These symptoms may include coughing, chest congestion, nasal congestion, itchy eyes, and sneezing. Some cough, cold, and allergy products may be purchased over the counter (OTC), while others require a prescription. 
 
Only certain unapproved prescription cough, cold, and allergy products are involved in this action.  The affected products fall into three categories: products in extended release form, products that contain tannates salts (e.g., phenylephrine tannate) as active ingredients, and certain immediate release products. (http://www.gpo.gov/fdsys/pkg/FR-2011-03-03/pdf/2011-4703.pdf) Today’s action does not affect OTC cough, cold, and allergy products.  
 
Q2: What makes a prescription cough, cold, and allergy drug product unapproved?
 
A: Unapproved prescription cough, cold, and allergy drug products are drugs that FDA has not found to be safe, effective, and of known identity, quality, and purity.
 
Q3: Are unapproved prescription cough, cold, and allergy drug products safe?
 
A: Unapproved prescription cough, cold, and allergy drug products have not been approved by the FDA for safety, effectiveness, and quality, therefore, patients may be at greater risk when using unapproved drug products than when using FDA-approved drug products. FDA-approved cough, cold, and allergy drug products have undergone rigorous evaluation by FDA, and, if used as directed, are safe and effective for treating cough, cold, and allergy symptoms.
 
FDA has several specific concerns about the potential risks of unapproved cough, cold, and allergy drug products:
  • Some of these drugs are inappropriately labeled for use in infants and children. 
  • Some products may be manufactured incorrectly, which could result in consumers receiving an inappropriately large or an ineffective dose.
  • Some of these products may have potentially risky combinations of ingredients.

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Q4: Is there a list of the unapproved prescription cough, cold, and allergy drug products that FDA intends to remove from the market?
 
A: Here is a list of the unapproved prescription cough, cold, and allergy drug products FDA intends to remove from the market. The list only includes drug products that are listed with FDA's Drug Registration and Listing System and therefore may not include all unapproved prescription cough, cold, or allergy drug products subject to today’s action that are being marketed.
 
 
Q5: What should consumers do if they currently take an unapproved prescription cough, cold, or allergy drug product?
 
A: Consumers who are currently taking or believe they may be taking an unapproved prescription cough, cold, or allergy drug product should talk to their healthcare professional about alternatives that are FDA-approved or that are legally marketed OTC. There are currently many drugs for cough, cold, and allergy symptoms on the market that meet FDA’s standards, both in prescription and OTC form.
 
Q6: How can a consumer know if the prescription drug they are using for cough, cold, or allergy symptoms is FDA-approved?
 
A: FDA provides the following resources that list FDA-approved prescription drugs. All of these can be searched by the name of the product or by its active ingredient(s), although consumers who search by the active ingredient(s) may need to know the name of the manufacturer in order to determine whether the product they are taking is approved
  • Drugs@FDA (contains most, although not all, FDA-approved drug products):
    If a product or active ingredient is not included here, the search results will say “Your search term did not return any results.”
  • The National Drug Code (NDC) Directory of prescription drugs and insulin products:
    Search results include a column marked "Appl No."  FDA-approved products will have an associated new drug application (NDA) number or abbreviated new drug application (ANDA) number in this column.
  • The Orange Book List of Approved Drug Products: 
    If a product or active ingredient is not approved, the search results will say, "No matching records found."
It should be noted that many OTC drugs do not require FDA approval to be legally marketed; therefore, these lists do not include many OTC drugs.
 
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Q7: What should healthcare professionals do if their patients currently take unapproved prescription cough, cold, and allergy drug products?
 
A: Healthcare professionals should review the list of unapproved cough, cold, and allergy drug products and discuss alternatives with patients currently taking these drugs. FDA expects little, if any, impact on the level of care healthcare professionals provide since many alternative cough, cold, and allergy drug products that are FDA-approved or are legally marketed OTC will remain on the market.
 
Q8: What should manufacturers do if they currently market unapproved prescription cough, cold, and allergy drug products?
 
A: Companies making and selling unapproved cough, cold, and allergy drug products covered by this action that are currently listed with FDA must stop manufacturing these products within 90 days after March 3, 2011 and must stop shipping within 180 days after March 3, 2011This is discussed in more detail in a Federal Register notice issued by FDA regarding these products (http://www.gpo.gov/fdsys/pkg/FR-2011-03-03/pdf/2011-4703.pdf) Companies making and selling unapproved cough, cold, and allergy drug products covered by this action that are not currently listed with FDA must stop manufacturing and shipping those products immediately. 
 
Companies that wish to market the drug products covered by this action after these deadlines can obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA) for their product or comply with the applicable OTC monograph and labeling requirements.
 
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Q9: Why are unapproved prescription cough, cold, and allergy drug products on the market and prescribed by healthcare professionals?
 
A: Over the past century, the laws outlining the requirements for drug approval have changed. First, drug regulation focused on adulteration and misbranding, but did not require that drug products be approved prior to being marketed. Then, laws on drug regulation changed to include drug safety as a requirement for approval. Currently, the law requires that new drugs be shown to be safe, effective, adequately labeled, and of appropriate manufacturing quality prior to being approved by FDA for marketing in the United States. In part as a result of these changes in the law, many of the products that are the focus of this action have been marketed without being approved under the current legal requirements. Many healthcare providers have been unaware of the unapproved status of these drug products and have unknowingly prescribed them because the drugs’ labels do not disclose that they lack FDA approval.
 
Q10: Are there any specific safety concerns related to the unapproved prescription cough, cold, and allergy drug products covered by this action that are labeled for children?
 
A: In 2008, FDA issued a public health advisory recommending that over-the-counter (OTC) cough and cold products not be used for infants and children under 2 years of age because serious and potentially life-threatening side effects could occur. Many pharmaceutical manufacturers of OTC products voluntarily relabeled cough and cold products to state that they should not be used in children less than 4 years of age. 
 
Many of the unapproved prescription cough, cold, and allergy drug products subject to this enforcement action contain the same ingredients as the OTC cough and cold products discussed in the 2008 public health advisory and are labeled for children under 2 years of age. The safety concerns discussed in the 2008 public health advisory apply to these unapproved prescription drug products as well. 
 
The American Academy of Pediatrics concurs that cough and cold medicines should not be given to infants and children under two years of age because of the risk of life-threatening side effects. They also note that several studies show that cold and cough products are not effective in children younger than six years of age and can have potentially serious side effects when used in that age group (http://www.aap.org/advocacy/releases/jan08coughandcold.htm).

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