E-DRUG: Re U.S. FDA's Proposal to Withdraw Terfenadine

Dear Joel,

First of all, let me clarify that presently terfenadine has not been
withdrawn in the U.S. The FDA proposes to withdraw the approval of
terfenadine and the manufacturers have been given an opportunity to
respond to the FDA's intention. And according to news report the leading
manufacturer will fight the withdrawal.
                                             
Secondly, as the FDA Talk Paper (included with Larry's posting) mentions
there is a relatively safer drug fexofenadine (which is the active
metabolite of terfenadine) which has been approved by the FDA and
presently does not appear to have the same side effects potential as the
parent drug terfenadine. I think this is the reason why the FDA has
proposed to withdraw terfenadine and not astemizole (which I agree has
similar serious drug interaction potential).

I hope this is helpful.
                                                                    
Syed Rizwanuddin Ahmad, MD, MPH

--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.