Foradil Aerolizer

Foradil Aerolizer (formoterol) is a prescription drug manufactured by Novartis that is used to treat Asthma. On March 15th 2006, the FDA requested that Novartis update their existing product label with a black box warning in response to a number of asthma-related deaths.

Foradil Aerolizer belongs to a class of drugs known as long-acting beta 2-adrenergic agonists (LABA), which are long acting bronchodilator medicines. These medicines are believed to make asthma episodes more severe when they occur. In one asthma medication study, a number of people taking a LABA died from their asthma compared to people taking placebo.

LABAs were originally developed to help relax the muscles in the lungs, however they have recently been linked with increasing the severity of asthma attacks.

The following is a public health advisory released by the FDA that highlights a number of recommendations about the use of LABA medications:

• LABAs should not be the first medicine used to treat asthma. LABAs should be added to the asthma treatment plan only if other medicines are unsuccesful.
• Patients should not stop using LABA or other asthma medications that healthcare providers have prescribed to them unless they have specifically discussed doing so with them.
• Patients should not use LABA to treat wheezing. If wheezing persists while on LABA, patients are urged to contact their physician immediately.
• LABAs do not relieve sudden wheezing. Patients should always have a short acting bronchodilator medication accessible.

Based on their findings, the FDA proposed a number of changes to the Foradil Aerolizer product label, stating that although LABAs decrease the number of asthma episodes, the medications may increase the severity of those episodes, which can potentially cause death.

Foradil Aerolizer Side Effects include:

• Death
• Allergic reaction: Itching or hives, swelling in face or hands, swelling or tingling in the mouth or throat, tightness in chest, trouble breathing
• Fast, pounding, or irregular heartbeat
• Worsening of asthma symptoms

If you notice these less serious side effects, talk with your doctor:

• Dizziness, shaking, nervousness, or headache
• Nausea, stomach pain, indigestion (especially in children)
• Stuffy or runny nose, hoarseness, sore throat, sneezing

If you or a loved one have experienced side effects from Foradil Aerolizer including sever asthma episodes, increased blood pressure, allergic reactions or death, please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.