Dear colleagues,
Since my November 29, 1995 posting on the above subject, I received a few
queries from list members to whom I have replied individually. I
received the following message from one individual:
"I am wondering whether I have the whole story of this issue. Which lots
of the product (Dilantin) didn't meet the standard of quality assurance?
Are these products sold in other countries? Did the company inform the
FDA in other countries. How can we check that there are this problem
drugs sold in our country?"
I think the above concern maybe relevant to folks in many parts of the
world and hence I am taking the liberty to post my reply to all list
subscribers.
The quality assurance problems of phenytoin (Dilantin) occured from 1990
to 1992. FDA has determined that the current formulation of phenytoin
in the U.S. market meets federal standards and is safe and that
Warner-Lambert (Parke Davis) has fixed the manufacturing problems.
According to a December 1, 1995 'Dear Healthcare Professional' letter
signed by the President of Parke-Davis in the U.S. "all of the lots
covered by the plea agreement have expired and are no longer on the market."
A spokesperson of the company told me today (Dec 4) that she has
to get back to me later regarding names of countries where phenytoin
may have been shipped from the U.S. "This information is not readily
available to us." However, the company spokesperson added that the
recall is applicable in overseas market too.
Meanwhile, the company's December 1 letter mentions that the product in
question is Dilantin (extended phenytoin sodium capsules, USP) Kapseals
as well as three other products that are no longer manufactured.
I hope the above information is useful.
Syed Rizwanuddin Ahmad 3831 Beecher Street, NW
Researcher Washington, DC 20007-1802, USA
Drug Safety, Education and Information Phone/Fax: 1-202-965-1518