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The Problem With Prescription Cough Suppressants

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Updated March 26, 2013

Cough medications are very common in the U.S. Since coughs are a very common symptom of many illnesses, it is understandable that people would want a medication to decrease the amount of coughing. There are many cough suppressants available over-the-counter as well as a few that are available as a prescription only.

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

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. 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.

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.

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 health care provider 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 have been manufacturing these medications have been 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.

Sources:

”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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