FDA Requires Warnings about Serious Mental and other Side Effects With Certain Asthma Drugs

The Food and Drug Administration (FDA) announced on June 12, 2009, that it is requiring new warnings about mood and behavior changes for all of the three available leukotriene-modifying drugs used to treat asthma: montelukast (SINGULAIR), zafirlukast (ACCOLATE) and zileuton (ZYFLO, ZYFLO CR).

These symptoms, referred to as neuropsychiatric symptoms, include agitation, aggression, dream abnormalities and hallucinations, anxiousness, depression, irritability, insomnia, restlessness, tremor, and suicidal thinking and behavior (including suicide).

The FDA advises health care professionals to "consider discontinuing these medications if patients develop neuropsychiatric symptoms (as described above)."

These drugs are classified as Do Not Use in Worst Pills, Best Pills News, both because of their limited effectiveness and other side effects.

The American College of Physicians, the national organization of internal medicine physicians, has stated that these drugs "have modest anti-inflammatory effects compared with corticosteroids and although they are considered alternatives to inhaled corticosteroids, they are not preferred treatment for patients with persistent asthma."

Other associated side effects

Montelukast has been the biggest-selling asthma drug in the United States for the past six years, with 25.8 million prescriptions filled in retail drug stores in 2008, even though it has serious problems with effectiveness and safety.

Both montelukast and zafirlukast are associated with a rare side effect called Churg-Strauss syndrome, a serious condition in which blood vessels become inflamed. According to Merck’s labeling for montelukast, the syndrome can involve "worsening pulmonary (lung) symptoms, cardiac complications, and/or neuropathy (nerve damage)."

Zafirlukast use has been linked to drug-induced lupus, a recurrence of ulcerative colitis (inflammation of the colon), and has also been associated with liver toxicity in reports in both medical journals and in FDA data files.

Patients taking zafirlukast who develop the signs and symptoms of liver toxicity (such as pain on the upper right side of the abdomen, nausea, fatigue, lethargy, itching, yellowing of the skin or eyes, flu-like symptoms or loss of appetite) should contact their physician immediately.

What You Can Do

You and your doctor should be aware of the potential for neuropsychiatric symptoms listed above with these medications.

Talk with your health care providers if these events occur.

Health care professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.