Elmiron (Pentosan Polysulfate Sodium Capsules) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Elmiron

Interstitial Cystitis »

Overview of urinary function

The urinary system consists of the kidneys, ureters, bladder, and urethra. The kidneys, a pair of purplish-brown organs, are located below the ribs toward the middle of the back. The kidneys remove water and waste from the blood in the form of urine, keeping a stable balance of salts and other substances in the blood. The kidneys also produce erythropoietin, a hormone that stimulates the formation of red blood cells. Narrow tubes called ureters carry urine from the kidneys to the bladder, a triangle-shaped, muscular chamber in the lower abdomen. Like a balloon, the bladder's muscular, elastic walls relax and expand to store urine and contract and flatten when urine is emptied through the urethra. The typical adult bladder can store about 1 ½ cups of urine.

Adults urinate about 1 ½ quarts of urine each day. The amount of urine varies depending on the fluids and foods a person consumes. The volume...

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SIDE EFFECTS

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® n=128	Placebo n=130
CNS	Overall Number of Patients*	3	5
Insomnia		1	0
Headache		1	3
Severe Emotional Lability/Depression		2	1
Nystagmus/Dizziness		1	1
Hyperkinesia		1	1
Gl	Overall Number of Patients*	7	7
Nausea		3	3
Diarrhea		3	6
Dyspepsia		1	0
Jaundice		0	1
Vomiting		0	2
Skin/Allergic	Overall Number of Patients*	2	4
Rash		0	2
Pruritus		0	2
Lacrimation		1	1
Rhinitis		1	1
Increased Sweating		1	0
Other	Overall Number of Patients*	1	3
Amenorrhea		0	1
Arthralgia		0	1
Vaginitis		1	1
Total Events		17	27
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.

Post-Marketing Experience

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.