FDA Tries to Reassure Epilepsy Patients Worried About Drug

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 patient should stop taking Dilantin unless directed 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 should not 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 between 1990 and 1992. Several batches of the drug did not dissolve quite at the proper rate.