News
02/27/1990

<TITLE>FDA Finds Moisture Causes Epilepsy Pill to Weaken </TITLE>
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FDA Finds Moisture Causes Epilepsy Pill to Weaken 


P90-14                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Mike Shaffer - (301) 443-3285 

    The Food and Drug Administration today announced the results of studies 
showing that carbamazepine, a drug relied upon by epilepsy patients to
prevent seizures, could lose one-third of its effectiveness if it is stored 
in humid conditions such as exist in most bathrooms.
    The studies may help explain why some patients have complained that the 
drug sometimes varies in its ability to prevent seizures. 
    The research was conducted by a team led by Jerome P. Skelly, Ph.D., at 
FDA laboratories in Washington, D.C., and by Marvin C. Meyer, Ph.D., in 
FDA-funded studies at the University of Tennessee College of Pharmacy in
Memphis.  The scientists plan to submit their findings for publication in a 
scientific journal. 
    FDA is asking manufacturers to change the products' packaging to keep 
out moisture. 
    For patients, FDA is reemphasizing its traditional advice to store drugs
in a cool, dry place.  The agency specifically advises people who use 
carbamazepine tablets to keep their supplies tightly closed, in a dry 
location and away from bathrooms, showers and humidifiers to reduce exposure
to moisture.
    FDA has met with the Epilepsy Foundation to describe the study results, 
and the foundation is helping to disseminate the information. 
                                   


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    The FDA and University of Tennessee researchers found that when 
carbamazepine tablets were exposed to humidity they hardened and then 
dissolved poorly in test liquids. 
    Blood samples from volunteers who took the drug confirmed that
carbamazepine tablets that dissolved poorly in laboratory tests also were 
absorbed poorly by the body.  Consequently, they would be less effective. 
    The tests did not involve carbamazepine sold as chewable tablets or in
liquid form.
    FDA is continuing to study carbamazepine and other products that may be 
subject to similar deterioration.  Carbamazepine is sold under the brand
name Tegretol by Ciba-Geigy Corporation of Ardsley, N.Y., and under more
than 15 generic label.    

This information is being transmitted in a video news release via 
satellite today, Feb. 28, 1:30 to 2 p.m. Eastern on coordinates Telstar 301,
Transponder 10 vertical (Ch. 19), audio 6.2 and 6.8.  For technical feed
information: Richard Feather (202) 783-8000.

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