Elmiron (Pentosan Polysulfate Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 Experience	ELMIRON® n=128	Placebo n=130
CNS Overall Number of Patients*	3	5
* 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.
Insomnia    Headache    Severe Emotional Lability/Depression    Nystagmus/Dizziness    Hyperkinesia	1 1 2 1 1	0 3 1 1 1
GI Overall Number of Patients*	7	7
Nausea    Diarrhea    Dyspepsia    Jaundice    Vomiting	3 3 1 0 0	3 6 0 1 2
Skin/Allergic    Overall Number of Patients*	2	4
Rash    Pruritus    Lacrimation    Rhinitis    Increased Sweating	0 0 1 1 1	2 2 1 1 0
Other Overall Number of Patients*	1	3
Amenorrhea    Arthralgia    Vaginitis	0 0 1	1 1 1
Total Events	17	27
Total Number of Patients Reporting Adverse Events	13	19

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.

Post-Marketing Experience:

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.

REPORTS OF SUSPECTED ELMIRON SIDE EFFECTS / ADVERSE REACTIONS

Possible Elmiron side effects / adverse reactions in female

Reported by a pharmacist from United States on 2011-10-14

Patient: female

Reactions: Post Procedural Haemorrhage

Adverse event resulted in: death

Suspect drug(s):
Elmiron

Other drugs received by patient: Heparin

Possible Elmiron side effects / adverse reactions in female

Reported by a pharmacist from United States on 2011-11-02

Patient: female

Reactions: Post Procedural Haemorrhage

Adverse event resulted in: death

Suspect drug(s):
Heparin
    Indication: Anticoagulant Therapy
    Start date: 2010-01-01
    End date: 2010-01-01

Elmiron
    Administration route: Oral
    End date: 2010-01-01

Heparin
    Dosage: 5000 units

Elmiron
    Administration route: Oral
    Indication: Cystitis Interstitial

Possible Elmiron side effects / adverse reactions in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 44 year old female weighing 58.1 kg (127.7 pounds)

Reactions: Breast Cancer, Drug Dose Omission

Suspect drug(s):
Elmiron
    Indication: Cystitis
    Start date: 2011-10-01

Elmiron
    Dosage: patient stopped for 3 months due to shortage