Highlights

Drug Warning

In 2007, the FDA requested the manufacturers of omalizumab (Xolair) to include a “boxed warning” emphasizing that this drug may cause a severe and life-threatening allergic reaction (anaphylaxis). Omalizumab is approved for patients who have moderate-to-severe asthma related to allergies and whose symptoms are not controlled by inhaled corticosteroids. It is given by injection in a doctor’s office every 2 - 4 weeks. The warning indicates that patients may develop anaphylaxis after any dose of omalizumab, even if they had no reaction to the initial shot. Health care providers need to observe patients carefully for 2 hours after they receive an omalizumab injection. However, because an allergic reaction can occur up to 24 hours after the injection, patients need to know the signs and symptoms of anaphylaxis and how to self-administer emergency treatment.

• Difficulty breathing
• Chest tightness
• Dizziness
• Fainting
• Itching and hives
• Swelling of the mouth and throat

Drug Approval

In 2006, the FDA approved budesonide/formoterol (Symbicort). Symbicort combines a corticosteroid and a long-acting beta2-agonist into a single inhaler.

Long-Acting Beta2-Agonists

• Long-acting beta2-agonist drugs, such as salmeterol (Serevent Diskus) and formoterol (Foradil Aerolizer), may worsen asthma symptom severity and increase the risk for asthma-related death, indicates a 2006 review in the Annals of Internal Medicine.
• Products that contain salmeterol and formoterol now have strengthened warning labels detailing these risks.

Asthma and Heartburn

Studies have suggested an association between heartburn, also known as gastroesophageal reflux disease (GERD), and asthma that gets worse at night (nocturnal asthma). A 2006 study tested whether a proton pump inhibitor drug might help improve morning breathing in patients who suffer from these two conditions. The results suggested that the drug provided only a moderate benefit.

Review Date: 12/21/2006
Reviewed By: Harvey Simon, MD, Associate Professor of Medicine, Harvard Medical School; Physician, Massachusetts General Hospital.

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