Vocalist.org archive


From:  "John Messmer" <jjm23@p...>
Date:  Tue Apr 18, 2000  3:45 pm
Subject:  Re: [vocalist-temporary] Finding info in PDR



----- Original Message -----
From: Nancy Mitchell <tmitche2@t...>
Subject: [vocalist-temporary] Finding info in PDR


> Dr. Messmer wrote:

>
> Since I'm the one who mentioned this medicine, I'd be very interested in
> knowing the potential side effects. Where would I find access to a PDR
> (Physician's Desk Reference)? (Know what PDR stands for as I used to do
> medical transcription.)

Well, this is a good question. It seems all my patients own PDR's
(Physician's Desk Reference) these days. As a physician I have it in bound
form and two electronic forms plus I have access to it on the Web. I just
tried to access it as though I were a non-physician and I realized that you
must subscribe to it.

I believe that most libraries have it in the reference section (but that is
an assumption). You can find it in most bookstores, at least in Waldenbooks
and B. Dalton. But for the sake of discussion, I have copied the adverse
reaction list from the PDR.net website for Singulair:

ADVERSE REACTIONS

Adolescents and Adults 15 Years of Age and Older

SINGULAIR has been evaluated for safety in approximately 2600 adolescent and
adult patients 15 years of age and older in clinical trials. In
placebo-controlled clinical trials, the following adverse experiences
reported with SINGULAIR occurred in greater than or equal to 1% of patients
and at an incidence greater than that in patients treated with placebo,
regardless of causality assessment:


Adverse Experiences Occurring in >/=1% of Patients
with an Incidence Greater than that in Patients Treated with Placebo,
Regardless of Causality Assessment SINGULAIR
10 mg/day
(%)
(n=1955) Placebo
NOTE THAT THE TABLE DOES NOT COPY WELL; THE FIRST NUMBER AFTER A SIDE
EFFECT IS THE SINGULAIR PERCENT; THE SECOND NUMBER IS THE PLACEBO PERCENT -
JOHN
(%)
(n=1180)
Body As A Whole
Asthenia/fatigue 1.8 1.2
Fever 1.5 0.9
Pain, abdominal 2.9 2.5
Trauma 1.0 0.8
Digestive System Disorders
Dyspepsia 2.1 1.1
Gastroenteritis, infectious 1.5 0.5
Pain, dental 1.7 1.0
Nervous System/Psychiatric
Dizziness 1.9 1.4
Headache 18.4 18.1
Respiratory System Disorders
Congestion, nasal 1.6 1.3
Cough 2.7 2.4
Influenza 4.2 3.9
Skin/Skin Appendages Disorder
Rash 1.6 1.2
Laboratory Adverse Experiences *
ALT increased 2.1 2.0
AST increased 1.6 1.2
Pyuria 1.0 0.9
*Number of patients tested (SINGULAIR and placebo, respectively): ALT and
AST, 1935, 1170; pyuria, 1924, 1159.


The frequency of less common adverse events was comparable between SINGULAIR
and placebo.

Cumulatively, 569 patients were treated with SINGULAIR for at least 6
months, 480 for one year, and 49 for two years in clinical trials. With
prolonged treatment, the adverse experience profile did not significantly
change.


Pediatric Patients 6 to 14 Years of Age

SINGULAIR has also been evaluated for safety in approximately 320 pediatric
patients 6 to 14 years of age. Cumulatively, 169 pediatric patients were
treated with SINGULAIR for at least 6 months, and 121 for one year or longer
in clinical trials. The safety profile of SINGULAIR versus placebo in the
double-blind, 8-week, pediatric efficacy trial was generally similar to the
adult safety profile with the exception of the adverse events listed below.
In pediatric patients receiving SINGULAIR, the following events occurred
with a frequency >/=2% and more frequently than in pediatric patients who
received placebo, regardless of causality assessment: diarrhea, laryngitis,
pharyngitis, nausea, otitis, sinusitis, and viral infection. The frequency
of less common adverse events was comparable between SINGULAIR and placebo.
With prolonged treatment, the adverse experience profile did not
significantly change.


Post-Marketing Experience

The following adverse reactions have been reported in post-marketing use:
hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, and
urticaria.

In rare cases, patients on therapy with SINGULAIR may present with systemic
eosinophilia, sometimes presenting with clinical features of vasculitis
consistent with Churg-Strauss syndrome, a condition which is often treated
with systemic corticosteroid therapy. These events usually, but not always,
have been associated with the reduction of oral corticosteroid therapy.
Physicians should be alert to eosinophilia, vasculitic rash, worsening
pulmonary symptoms, cardiac complications, and/or neuropathy presenting in
their patients. A causal association between SINGULAIR and these underlying
conditions has not been established (see PRECAUTIONS , Eosinophilic
Conditions ).

Eosinophilic Conditions

In rare cases, patients on therapy with SINGULAIR may present with systemic
eosinophilia, sometimes presenting with clinical features of vasculitis
consistent with Churg-Strauss syndrome, a condition which is often treated
with systemic corticosteroid therapy. These events usually, but not always,
have been associated with the reduction of oral corticosteroid therapy.
Physicians should be alert to eosinophilia, vasculitic rash, worsening
pulmonary symptoms, cardiac complications, and/or neuropathy presenting in
their patients. A causal association between SINGULAIR and these underlying
conditions has not been established (see ADVERSE REACTIONS ).

------------------

You should realize that any symptom that shows up during testing must be
listed even if it is not likely to be from the medication.

BTW, there is a consumer section of www.pdr.net but it is not the same as
the physician section.

John

John Messmer, MD, Assistant Professor, Family & Community Medicine
Medical Director, Penn State Geisinger Health Group, Palmyra, PA

"Try not. Do or do not; there is no 'try'." -- Yoda


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