FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market
This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
the possibility of improper use in infants and young children
potentially risky combinations of ingredients
patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:
You can visit the FDA website (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm244852.htm) for more information about this action to remove unapproved cough, cold, and allergy products from the market.
You can find a list of unapproved products by going to (http://goo.gl/Gqc7d).
For information on how to dispose of unused products, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Pseudoephedrine comes as a regular tablet, a 12-hour extended-release (long-acting) tablet, a 24-hour extended-release tablet, and a solution (liquid) to be taken by mouth. The regular tablets and liquid are usually taken every 4 to 6 hours. The 12-hour extended-release tablets usually are taken every 12 hours, and you should not take more than two doses in a 24-hour period. The 24-hour extended-release tablets usually are taken once a day, and you should not take more than one dose in a 24-hour period. To help prevent trouble sleeping, take the last dose of the day several hours before bedtime. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pseudoephedrine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.
Pseudoephedrine comes alone and in combination with other medications. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using 2 or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
Nonprescription cough and cold combination products, including products that contain pseudoephedrine, can cause serious side effects or death in young children. Do not give other nonprescription pseudoephedrine products to children younger than 4 years of age. If you give these products to children 4-11 years of age, use caution and follow the package directions carefully. Do not give pseudoephedrine extended-release tablets to children younger than 12 years of age.
If you are giving pseudoephedrine or a combination product that contains pseudoephedrine to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give pseudoephedrine products that are made for adults to children.
Before you give a pseudoephedrine product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.
If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
If your symptoms do not get better within 7 days or if you have a fever, stop taking pseudoephedrine and call your doctor.
Swallow the extended-release tablets whole; do not break, crush, or chew them.
This medication is also sometimes used to prevent ear pain and blockage caused by pressure changes during air travel or underwater diving. Talk to your doctor or pharmacist for more information.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Foods and drinks that contain large amounts of caffeine can make the side effects of pseudoephedrine worse.
This medication is usually taken as needed. If your doctor has told you to take pseudoephedrine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
fast, pounding, or irregular heartbeat
Pseudoephedrine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
If you are taking the 24-hour extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
Ask your pharmacist any questions you have about pseudoephedrine.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
§ These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs (http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).
Last Revised - 07/08/2011
AHFS® Consumer Medication Information. © Copyright, 2013. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.