ROANOKE TIMES
Copyright (c) 1995, Roanoke Times
DATE: Monday, December 4, 1995 TAG: 9512050023
SECTION: NATIONAL/INTERNATIONAL PAGE: A-8 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
The Food and Drug Administration is trying to reassure epilepsy patients that a popular drug investigated for quality fluctuations is safe to use - because the concerns are more legal than medical.
``We have no evidence ... that the Dilantin available today is not performing as expected in patients,'' the FDA said in response to dozens of phone calls from epilepsy patients worried after Dilantin's maker, Warner Lambert Inc., pleaded guilty to a felony for hiding quality problems with the drug.
No one should stop taking Dilantin unless told to by a doctor, because stopping could cause serious seizures, the FDA said.
But some patients question whether they can believe the reassurance, saying the FDA shouldn't have waited three years to unveil its investigation of Dilantin and never told consumers the drug was recalled eight times this year alone.
``How can I have any faith in the FDA or any drug ever again?'' asked Betty Gruehl of South Euclid, Ohio, whose son suffered two days of life-threatening seizures while taking Dilantin in 1991.
Warner-Lambert agreed last week to pay a $10 million fine for concealing quality problems with Dilantin from 1990 to 1992. Several batches of the drug did not dissolve at the proper rate, but the FDA said the fluctuations were too minor to endanger anyone.
Federal records show Warner-Lambert recalled Dilantin eight times this year, mostly for the same quality fluctuations.
Many epileptics suffer seizures despite taking medication. The FDA has not detected any increase in seizures by Dilantin patients since the fluctuations began in 1990.
This year's Dilantin recalls, and the fluctuations before 1992, were for minor problems that were not dangerous, said Dr. Murray Lumpkin, the FDA's deputy drug director, so the FDA didn't consider it necessary to alarm patients by telling them of the recalls.
Patients may get more Dilantin information by calling the FDA at (301) 443-5006 or Warner-Lambert at (800) 221-5618.
LENGTH: Short : 48 linesby CNB