Drug Information for ELMIRON -100 mg (pentosan polysulfate sodium) Capsules (Ortho-McNeil-Janssen Pharmaceuticals, Inc.): ADVERSE REACTIONS

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  • ELMIRON® was evaluated in clinical trials in a total of 2627 patients (2343 women, 262 men, 22 unknown) with a mean age of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the 2627 patients, 128 patients were in a 3 month trial and the remaining 2499 patients were in a long term, unblinded trial.

    Deaths occurred in 6/2627 (0.2%) patients who received the drug over a period of 3 to 75 months. The deaths appear to be related to other concurrent illnesses or procedures, except in one patient for whom the cause was not known.

    Serious adverse events occurred in 33/2627 (1.3%) patients. Two patients had severe abdominal pain or diarrhea and dehydration that required hospitalization. Because there was not a control group of patients with interstitial cystitis who were concurrently evaluated, it is difficult to determine which events are associated with ELMIRON® and which events are associated with concurrent illness, medicine, or other factors.

    Adverse Experience In Placebo-Controlled Clinical Trials of ELMIRON® 100 mg Three Times a Day for 3 Months
    Body System/Adverse ExperienceELMIRON®n=128Placebon=130
    CNS Overall Number of PatientsWithin a body system, the individual events do not sum to equal overall number of patients because a patient may have more than one event.35
    Insomnia10
    Headache13
    Severe Emotional Lability/Depression21
    Nystagmus/Dizziness11
    Hyperkinesia11
    GI Overall Number of Patients77
    Nausea33
    Diarrhea36
    Dyspepsia10
    Jaundice01
    Vomiting02
    Skin/Allergic Overall Number of Patients24
    Rash02
    Pruritus02
    Lacrimation11
    Rhinitis11
    Increased Sweating10
    Other Overall Number of Patients13
    Amenorrhea01
    Arthralgia01
    Vaginitis11
    Total Events1727
    Total Number of Patients
    Reporting Adverse Events1319

    The adverse events described below were reported in an unblinded clinical trial of 2499 interstitial cystitis patients treated with ELMIRON®. Of the original 2499 patients, 1192 (48%) received ELMIRON® for 3 months; 892 (36%) received ELMIRON for 6 months; and 598 (24%) received ELMIRON® for one year, 355 (14%) received ELMIRON® for 2 years, and 145 (6%) for 4 years.

    Frequency (1 to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).

    Frequency (= 1%):

    Digestive: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, gum hemorrhage.

    Hematologic: Anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, leukopenia, thrombocytopenia.

    Hypersensitive Reactions: Allergic reaction, photosensitivity.

    Respiratory System: Pharyngitis, rhinitis, epistaxis, dyspnea.

    Skin and Appendages: Pruritus, urticaria.

    Special Senses: Conjunctivitis, tinnitus, optic neuritis, amblyopia, retinal hemorrhage.

  • Rectal Hemorrhage

  • ELMIRON® was evaluated in a randomized, double-blind, parallel group, Phase 4 study conducted in 380 patients with interstitial cystitis dosed for 32 weeks. At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. The severity of the events was described as "mild" in most patients. Patients in that study who were administered ELMIRON® 900 mg daily, a dose higher than the approved dose, experienced a higher incidence of rectal hemorrhage, 15%.

  • Liver Function Abnormality

  • A randomized, double-blind, parallel group, phase 2 study was conducted in 100 men (51 ELMIRON® and 49 placebo) dosed for 16 weeks. At a daily dose of 900 mg, a dose higher than the approved dose, elevated liver function tests were reported as an adverse event in 11.8% (n = 6) of ELMIRON® treated patients and 2% (n = 1) of placebo treated patients.

  • Drug Information Provided by National Library of Medicine (NLM).
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