The Problem With Prescription Cough Suppressants

Boy taking medicine
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Cough medicines are very common in the U.S. Since coughs are a common symptom of many illnesses, it is understandable that people would want a medicine that would make. it. stop. There are many cough suppressants available over-the-counter as well as a few that are available by prescription only.

Over the Counter Options

Over-the-counter cough suppressants, which contain a product called dextromethorphan, tend to be less effective, but may be helpful for minor coughs.

Expectorants are a type of medicine that don't stop a cough but instead loosen mucus, making the cough more productive and effective. 

When to See a Doctor

If you have a severe or chronic cough that lasts longer than three weeks, it should be evaluated by your health care provider and prescription cough suppressants should only be used when absolutely necessary. Coughs -- especially chronic coughs -- can be caused my many things and it is best to try to treat the underlying cause rather than just trying to cover it up. This involves more than just taking a medicine to make the cough stop.

Where the Problem Lies

In recent years, there has been a big problem with prescription cough suppressants being prescribed and sold when they are not approved by the FDA. Currently, there are only seven prescription cough suppressants that are approved by the FDA.

They include:

  • Tussicaps
  • Tussionex Pennkinetic
  • Hydrocodone Compound
  • Mycodone
  • Homatroprine Methylbromide and Hydrocodone Bitartrate
  • Hycodan
  • Tussigon

All of these prescription cough suppressants contain an opiate (hydrocodone) which has been proven effective to control a cough in adults and children over 6. However, they should be avoided by people who may be recovering from an addiction to opioids because it is just not worth the risk of relapse to treat a simple cough.

These medications should only be used for adults and children over the age of 6. Some of them are marketed and have dosing instructions for children as young as 2. However, the FDA has stated that these medications are not safe for and should not be used for children under age 6.

Using medications "off label" is not new and it's not even all that uncommon, especially in pediatrics. Very few drug trials are performed on kids because not a lot of people want to sign their kids up for "experimental" medicines and getting these trials approved is much more difficult than it is for adults.  Unfortunately, there isn't a lot of incentive (money) in it for the manufacturers of the medicines either. 

But giving these prescription cough medicines to kids is dangerous. They can slow their breathing to dangerous levels and can even be fatal. 

The other main problem is that some prescription cough suppressants are being sold that are intended to treat multiple symptoms.

The FDA has only approved prescription cough suppressants to include hydrocodone and the suppressant. Any medication that includes other ingredients (such as an expectorant or decongestant) is not approved by the FDA and should not be prescribed or sold in the United States.

Your Doctor Didn't Know

The scariest part about this problem is that many health care providers did not know these drugs were not approved and have been prescribing them. These are not medications that you can only buy on the “black market” or through the internet. They are medications that you may be prescribed by your doctor and buy at your local pharmacy.

The FDA is not reporting any adverse events with these medications (except when given to children under 6) so there is likely little harm that has been done. However, the fact is that these medications have been manufactured and sold and were never approved. As of March 31st, 2008 all companies that were manufacturing these medications were ordered to stop producing and selling them. After that date, if a company is still selling these products, they may face penalties from the FDA.


”Questions and Answers About FDA’s Enforcement Action Regarding Unapproved Hydrocodone Drug Products.” U.S. Food and Drug Administration 01 Oct 07.21 Mar 08.

”FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone.” FDA News Press Release 11 Mar 08. U.S. Food and Drug Administration.24 Mar 08.

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