Formoterol important warning

In a large clinical study, more patients who used an asthma medication similar to formoterol died of asthma problems than patients who did not use the medication. If you have asthma, use of formoterol may increase the chance that you will experience serious or fatal asthma problems. Your doctor will only prescribe formoterol if other medications have not controlled your asthma or if your asthma is so severe that two medications are needed to control it. Formoterol should not be the first or the only medication that you use to treat your asthma.

Do not use formoterol if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately:

• your short-acting inhaler [inhaled medication such as albuterol (Proventil, Ventolin) that is used to treat sudden attacks of asthma symptoms] does not work as well as it did in the past
• you need to use more puffs than usual of your short-acting inhaler or use it more often
• you need to use four or more puffs per day of your short-acting inhaler for 2 or more days in a row
• you use more than one canister (200 inhalations) of your short-acting inhaler during an 8-week period
• your peak-flow meter (home device used to test breathing) shows your breathing is worsening
• you need to go to the emergency room for asthma treatment
• your symptoms do not improve after you use formoterol regularly for 1 week or your symptoms get worse at any time during your treatment

Talk to your doctor about the risks of using this medication.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with formoterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.