THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Tuesday, July 16, 1996 TAG: 9607160284
SECTION: FRONT PAGE: A4 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: SILVER SPRING, MD. LENGTH: 56 lines
A new drug to battle schizophrenia should be approved despite concerns that it could pose a risk of irregular heartbeats, psychiatric experts told the Food and Drug Administration Monday.
Abbott Laboratories hopes to sell sertindole as a safer alternative to older schizophrenia drugs that cause side effects, including loss of motor control and tremors, which prompt some schizophrenics to abandon their medicine.
Only one other schizophrenia drug has a similarly low risk of side effects, Janssen Pharmaceutica's No. 1-selling risperidone. While doctors laud risperidone, they say they need alternatives because 25 percent of the nation's 2.5 million schizophrenics don't respond to any medicine sold today.
The FDA never disputed that Abbott's sertindole works as well as older schizophrenia medicines.
But FDA physicians saw a red flag: 27 people died in sertindole's studies, including 13 ``sudden deaths,'' people who literally dropped without any warning.
Although there is no proof that sertindole caused those deaths, the drug already had attracted scrutiny because it causes a small abnormality in patients' heartbeats, said FDA cardiac expert Dr. Raymond Lipicky.
Heartbeats pause for a fraction of a second while the heart's electrical current recharges. If that pause is too long, the heart beats so irregularly that, if it doesn't quickly get back on track, patients can die.
Sertindole prolongs that heartbeat pause, as do many other drugs that are sold with warnings urging extreme caution in their use. The difference: Studies have documented that those drugs kill but not that sertindole does.
``I think that this is a dangerous drug,'' said Lipicky, as FDA officials argued that sertindole caused more mysterious deaths than other schizophrenia drugs.
But Dr. Edward Pritchett of Duke University, a cardiologist Abbott asked to study the issue, said sertindole only lengthened the heartbeat's pause an average of 22 milliseconds, something no one has proved is dangerous by itself.
``I can't stand here and tell you that . . . (arrhythmia) will not occur with this drug. I can tell you the risk is very low,'' Pritchett said.
After eight hours of debate, the FDA's advisers sided with Abbott, voting 4-2 that sertindole was safe enough to approve. The psychiatrists did say, however, that they doubted sertindole would become a first-line therapy because of the questions.
The FDA is not bound by the advisory panel decisions but usually follows them.
Abbott said it would continue studying sertindole, to be sold under the brand name Serlect, to better understand the heartbeat abnormality.
KEYWORDS: FDA DRUG SCHIZOPHRENIA by CNB