ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® and which events are associated with concurrent illness, medicine, or other factors.
Adverse Experience In Placebo-Controlled Clinical Trials of ELMIRON (pentosan polysulfate sodium capsules) ® 100 mg Three Times a Day for 3 Months
|Body System/ Adverse Experience|| ELMIRON®
|CNS||Overall Number of Patients*||3||5|
|Severe Emotional Lability/Depression||2||1|
|Gl||Overall Number of Patients*||7||7|
|Skin/Allergic||Overall Number of Patients*||2||4|
|Other||Overall Number of Patients*||1||3|
|Total Number of Patients Reporting Adverse Events||13||19|
|* Within a body system, the individual events do not sum to equal overall number of patients because a patient may have more than one event.|
The adverse events described below were reported in an unblinded clinical trial of 2499 interstitial cystitis patients treated with ELMIRON (pentosan polysulfate sodium capsules) ®. Of the original 2499 patients, 1192 (48%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 3 months; 892 (36%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 6 months; and 598 (24%) received ELMIRON (pentosan polysulfate sodium capsules) ® for one year, 355 (14%) received ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® treated patients and 2% (n = 1) of placebo treated patients.