From: R&M Whitworth [rmwhit@aaahawk.com]
Sent: Friday, January 05, 2001 12:09 AM
To: Morrison, James C
Subject: Phenylpropanolamine discontinuation OTC-vs-Rx Only

Mr. Morrison:

I'm addressing this to you in hopes that if you cannot answer my
questions (comments), you could forward my email to someone who could.
I am a clinical pharmacist practicing in San Antonio, TX and I, along
with several of my colleagues and patients, are quite distressed at the
TOTAL elimination of Phenylpropanolamine (PPA) from all drug products.

I've been in practice since 1987 and I keep up with adverse drug
reactions, have participated in MedWatch, etc.  Along with my fellow
pharmacists, we understand the danger that PPA can pose in some
patients.  This information has been passed on to patients as a regular
part of practice.

I understand the need to protect public health and safety, and it is an
area that as a profession we are constantly involved in.  However, the
withdrawal of PPA in prescription only drugs seems to be throwing out
the baby with the bath water.  The obvious reformulation of any product
that is Rx only would be to add pseudoephedrine but I have patients who
cannot tolerate pseudoephedrine and have been using PPA for YEARS.  The
risk-vs-benefit ratio that any physician uses in prescribing a
particular drug would still be in play with PPA in Rx medications.  It
just seems, especially in this part of the country, that the FDA has
made an extremely poor decision.  Entex LA (and its generic equivalents)
are some of the most prescribed drugs in this area for a reason.  In
many cases this drug, along with others is used prophylactically to
avoid upper respiratory infections which plague this area.  Combine this
with the large diabetic population (at higher risk of infections) and
you can see the need for the use of PPA as a prescription drug.

I am not completely sure as to the procedure, but I already know that if
I were to start a petition among pharmacists (and several physicians) to
reverse the FDA's decision to entirely eliminate PPA in Rx medications,
I could get a huge number of signatures.

The pharmaceutical manufacturers are going to go along with your
recommendations to avoid possible lawsuits brought by lawyers looking to
make a quick buck on this situation.  From a clinical position, the
risks posed by PPA in prescription drugs is no more great than those
posed by other medications still on the market today.  Adding a warning
to PPA containing Rx drugs would suffice, but completely eliminating PPA
in all Rx meds seems to go over the mark.

Please email me back as to the procedure for challenging this decision
if you would.

I appreciate your time and hope if you are not the contact person for
this issue you forward it to the person who is.

Sincerely,
Randy G. Whitworth, R.Ph.
130 Fantasia Drive
San Antonio, TX  78216
work phone 800-803-1378
home 210-366-1418