E-DRUG: FDA'S HEALTH ADVISORY FOR NEW ASTHMA DRUG
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Dear E-druggers,
Today, the U.S. Food and Drug Administration (FDA) issued a health
advisory for the new asthma drug zafirlukast (brand name: Accolate.
manufacturer: Zeneca) which is posted below. Watch out!
Syed Rizwanuddin Ahmad
Division of Information Development
United States Pharmacopeial Convention, Inc
12601 Twinbrook Parkway
Rockville, MD 20852, USA
Email: ra@usp.org
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Zafirlukast (Accolate), a popular asthma treatment, has
recently been associated with a rare and sometimes fatal
condition known as Churg-Strauss Syndrome. The drug's
manufacturer, Zeneca Pharmaceuticals, is now notifying health
care providers of this possible drug side effect after FDA
learned of six asthma patients who developed Churg-Strauss
Syndrome while taking zafirlukast. These data, however, do not
definitively demonstrate that the drug caused the condition.
Churg-Strauss Syndrome occurs in adult asthma patients and
may appear as generalized, flu-like symptoms such as fever,
muscle aches and pains, and weight loss. Patients also
experience inflammation of blood vessels, primarily in the lungs. If left untreated, Churg-Strauss
Syndrome can result in major
organ damage and even death.
Despite the severity of Churg-Strauss Syndrome, in light of
the rarity of its occurrence FDA does not recommend that patients
discontinue any asthma medication without consulting their health
care provider. In fact, Churg-Strauss Syndrome is often treated
with oral steroids, the same treatment that is used for patients
with severe asthma. Based on present information, the agency
continues to believe the benefits of this drug outweigh any of
its known or potential risks.
Thus far, all reported cases have occurred in patients whose
steroidal asthma medications were being gradually lowered or
discontinued while receiving zafirlukast. New labeling for
zafirlukast will warn health care providers of this possible
problem and urge them to monitor their patients carefully when
corticosteroids are being tapered or discontinued.
Approved in September 1996, zafirlukast is the first in a
new class of drugs designed as a nonsteroidal, asthma prophylaxis
and treatment for patients aged 12 or older.
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