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 emphasized.
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 between 1990 and 1992. Several batches of the drug did not dissolve quite at the proper rate - off by between one and three percentage points - 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. The company also issued an additional 12 recalls for other products, while the most issued by any other drug firm this year was six, said consumer advocate Dr. Sidney Wolfe.
Many epilepsy patients suffer seizures despite taking medication, but the FDA has not detected any increased seizures by Dilantin patients since the fluctuations began in 1990.