NEWS
08/01/1994

<TITLE>Suspension of Felbatol Use Urged</TITLE>








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<PRE>
August 1, 1994                                      Susan Cruzan
                                                     (301) 443-3285


                Suspension of Felbatol Use Urged

     The Food and Drug Administration today recommended the
immediate withdrawal of patients from the antiepilepsy drug
Felbatol because it has been linked to 10 cases of aplastic anemia. 
In a "Dear Doctor" letter to 240,000 physicians, Carter-Wallace,
Inc., the drug's manufacturer, in conjunction with the FDA
recommended suspension of Felbatol therapy, "unless in the
physician's judgement, an abrupt withdrawal would be deemed to pose
a more serious risk to the patient."
       Aplastic anemia is a rare and frequently fatal form of bone
marrow failure.  The rate of aplastic anemia cases reported with
Felbatol appears to be about 50 times higher than expected.
However, since the syndrome is still relatively rare, no cases were
observed in premarket testing in which approximately 1000 patients
were exposed to Felbatol.  All reports of aplastic anemia
associated with Felbatol have been in patients on the drug for at
least 2 1/2 months.   
     "We strongly recommend that patients consult their physician
as soon as possible, but it is critical that they not discontinue
the drug on their own due to the risk of seizures," said FDA
Commissioner David A. Kessler, M.D.  "Physicians should prescribe 
                             -More-

                                                Felbatol-page 2
this drug only if it is absolutely necessary."   
     In those rare cases where Felbatol is continued, FDA suggests
careful monitoring.  However, there is no evidence that even close
monitoring can protect against the occurrence of aplastic anemia.
     Felbatol was approved in August 1993 for partial seizures with
and without secondary generalization in adults and for Lennox-
Gastaut Syndrome, a serious form of childhood epilepsy.
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</PRE>





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