----- 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 ).
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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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