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BRAND NAMEINSPIREASE DRUG DELIVERY SYSTEM
MANUFACTURER
SCHERING-PLOUGH CORP.
2000 GALLOPING HILL RD
KENILWORTH NJ 07033
ACCESS NUMBERM188156
PRODUCT CODECCQ
PANELANESTHESIOLOGY
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED04/04/1990
DEVICE CATALOGUE NUMBER0085-4602-02
EVENT DESCRIPTION TYPEPRELIMINARY
EVENT DESCRIPTION
A 26-YR-OLD MALE WITH A FOUR-YR HISTORY OF INTERMITTENT ASTHMA NOTED THE ONSET OF SHORTNESS OF BREATH ONE EVENING. HE TREATED HIMSELF WITH TWO PUFFS OF ALBUTEROL VIA A METERED-DOSE INHALER USING DRUG DELIVERY SYSTEM. ALTHOUGH THE PT'S COUGH AND DYSPNEA IMPROVED, HE NOTED THE ONSET OF PALPITATIONS WHEN HE WENT TO BED. UPON ARISING THE FOLLOWING DAY, HE FELT NAUSEATED, MILDLY DIAPHORETIC AND STILL HAD PALPITATIONS. AN EKG DEMONSTRATED ATRIAL FIBRILLATION, AND THE PT WAS TREATED WITH INDERAL. A SHORT TIME LATER, HIS PALPITATIONS CEASED; REPEAT EKG DEMONSTRATED NORMAL SINUS RHYTHM. THESE EPISODES RECURRED WHEN THE PT USED ALBUTEROL WITH INSPIREASE. MEDICAL EVALUATION, INCLUDING THYROID FUNCTION, HOLTER MONITOR, ECHOCARDIOGRAM, AND STRESS TEST WERE NORMAL. PULMONARY FUNCTION TESTS REVEALED MILD VARIABLE AIRFLOW OBSTRUCTION. NO OTHER ORAL OR INHALER MEDICATIONS WERE USED, AND THE PT HAD NO PAST CARDIAC HISTORY. UNIT WAS WAS DISCONTINUED, AND THE ALBUTEROL METERED-DOSE INHALER WAS USED ALONE, WITHOUT RETURN OF CARDIAC SYMPTOMS. AN EXERCISE STUDY WITH CARDIAC MONITORING FAILED TO DOCUMENT ANY ISCHEMIC CHANGES OR ARRHYTHMIAS, EITHER WITH OR WITHOUT INHALED ALBUTEROL. IT IS THE REPORTER'S FEELING THAT THE ALBUTEROL TRIGGERED ATRIAL FIBRILLATION IN THIS PT PRINCIPALLY THROUGH THE INCREASED DOSE MADE AVAILABLE BY USING THE UNIT. THIS IS FROM NEW JERSEY MEDICINE VOLUME 87 NO 2 FEB 90. (SEE FILE).
CLOSEOUT TEXT
THE CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE RESULT OF PHYSIOLOGICAL OR PROCEDURAL FACTORS.
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