I cannot see why anyone would ever take Elmiron as a first choice drug again. :icon13:
Many men are paying big money (around $200/month in the US) to buy what for most is nothing more than an expensive and possibly dangerous placebo.
Read what women are reporting after using Elmiron:
Other patients report: itching, crumbling fingernails, bleeding that is difficult to stop (see case below), burning sensation in vagina and urethra, cataracts.I have my liver panels checked every 3 months for Elmiron. Also, my Elmiron sheet says that if you start bruising easily or notice abnormal bruising, to let your doctor know. I've cut myself a few times and the bleeding went on for a looooong time...the doc said that's from the Elmiron"¦.
If you are using Elmiron the drug fact sheet that comes with Elmiron recommends that you have your liver tested every 6 months"¦.
"¦.took Elmiron for six months. It caused diarrhoea and did not help my IC/CPPS. The diarrhoea stopped as soon as I stopped taking Elmiron. "¦.
"¦.I've been so nauseous since starting Elmiron 3 1/2 weeks ago. My dr. said it would go away but I always feel like I'm going to loose it.
"¦.I had nausea for 6 weeks when I first started taking Elmiron in 1997. It was so bad that I had to take anti-nausea medication.
.... my hair has started to fall out since starting Elmiron.
.... I cannot see at night after using Elmiron for 4 months. My night vision is gone.
In clinical trials, the following reactions were reported: (frequency ~4%): alopecia (baldness), diarrhoea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, dizziness.
Other reactions reported were:
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 (nosebleeds), dyspnea.
Skin and Appendages: Pruritus (itching), urticaria.
Special Senses: Conjunctivitis, tinnitus, optic neuritis, amblyopia, retinal hemorrhage (bleeding in eye).
Elmiron used to be owned by Alza Pharmaceuticals. They were bought recently by Johnson & Johnson. (You may remember that J&J were responsible for PROPULSID, a heartburn drug that disturbed cardiac function and resulted in the deaths of many children before it was withdrawn from sale. Propulsid has been cited as a suspect in 302 deaths.)
Here is evidence that Elmiron may have fatal side effects (this woman could have died without prompt medical care):
Massive Bleeding on a Bladder Protectant
A Case Report of Pentosan Polysulfate Sodium--Induced Coagulopathy
Sharlene Gill, MD; Sheldon C. Naiman, MD; Abeed Jamal, MD; Linda M. Vickars, MD
Arch Intern Med. 2002;162:1644-1645. ABSTRACT
Pentosan polysulfate sodium (Elmiron; Alza Pharmaceuticals, Mountain View, Calif) is an oral preparation of pentosan polysulfate used in the symptomatic management of interstitial cystitis. While pentosan polysulfate has a known heparinlike effect in its parenteral form, there have been no previous reports of coagulopathy with oral use. We present an interesting case of inadvertent systemic anticoagulation resulting in serious bleeding complications in a young woman taking oral pentosan polysulfate for interstitial cystitis.
A 17-year-old white girl was transferred to a tertiary care hospital following a carotid puncture during an attempted right internal jugular catheter insertion. She was subsequently admitted to the intensive care unit for airway and vascular management of an expanding neck hematoma necessitating intubation and associated with significant blood loss. On transfer, she was noted to have a coagulopathy with an international normalized ratio of 1.5 (normal, 0.9-1.1) and a significantly prolonged activated partial thromboplastin time (aPTT) of 61 seconds (normal, 25-37 seconds). Her white blood cell count was 28.4 x 106/µL, hemoglobin was 5.9 g/dL, and platelet count was 218 x 103/µL with unremarkable findings on peripheral smear. Renal and hepatic function were normal. Coagulation parameters had not been obtained prior to her central venous catheter insertion. Our patient had initially presented to her community hospital with an ulcerative colitis exacerbation requiring corticosteroid therapy and narcotics. The central venous catheter insertion was attempted in anticipation of commencing total parenteral nutrition. A diagnosis of interstitial cystitis was established 2 years prior with a modest improvement with imipramine and escalating doses of oral pentosan polysulfate sodium from the standard dose of 100 mg orally 3 times a day1 to a dose of 300 mg orally 3 times a day for the last 4 months. There was no history of a bleeding diathesis. An urgent contrast-enhanced computed tomographic scan of the neck and chest revealed an extensive 5.0 x 6.5-cm hematoma in the right side of the neck, causing tracheal deviation with displacement of the right common carotid artery and internal jugular vein and resulting in secondary compression of the superior vena cava. As reported in Table 1, further coagulation studies were executed on an MLA Electra1400 coagulation analyzer (Dade Behring, Mississauga, Ontario). Activated partial thromboplastin time was performed on plasma using Actin FSL (Dade Behring) and thrombin time was measured with Fibrindex human thrombin reagent (Ortho Diagnostics, Raritan, NJ). Batroxobin reagent (Reptilase; Pentapharm Ltd, Basel, Switzerland) was used to measure reptilase clotting time and heparin assay was performed through determination of factor Xa inactivation with S-2222 as a chromogenic substrate (Coatest Heparin; Diapharma Group, Inc, West Chester, Ohio). Studies for heparin absorption used heparin absorbent (Prob-Tek; Inotech Biosystems International, Rockville, Md). Measurable anti-Xa activity, prolonged thrombin time with a normal reptilase time, and normalization of aPTT with heparin absorption confirmed this to be a heparinoid effect. Heparin contamination was excluded by clinical assessment, yet repeated studies were consistent with a systemic anticoagulation effect as would be seen with full-dose unfractionated heparin. She required a total of 4 units of fresh frozen plasma and 6 units of packed red blood cells. The causative agent was concluded to be pentosan polysulfate with normalization of her coagulation parameters following discontinuation. She was subsequently extubated and transferred to the medical ward. Pentosan polysulfate treatment was not resumed.
Interstitial cystitis is a bladder disorder of an unknown, multifactorial etiology. An abnormal, inflamed bladder mucosa due to an insufficient glycosaminoglycan protectant layer has been postulated as a cause of interstitial cystitis. The beneficial effects of pentosan polysulfate in this setting are attributed to its properties as a glycosaminoglycan substitute.2-3 Since approval in 1996, the oral formulation of pentosan polysulfate (Elmiron) has emerged as front-line therapy in the management of interstitial cystitis. The parenteral anticoagulant effect of pentosan polysulfate is comparable to heparin, with prolongation of the aPTT by an inconclusive mechanism, independent of an antithrombin III and heparin cofactor II--mediated effect. Additionally, ex vivo anti-Xa activity is demonstrated.4 The oral bioavailability of pentosan polysulfate is poor and erratic, estimated at 3%.1 A study of oral pentosan polysulfate administered to 18 healthy volunteers reported negligible bioavailability after a single dose of 1500 mg failed to alter coagulation parameters.5 Furthermore, trials using oral pentosan polysulfate sodium doses greater than 900 mg/d reported no significant coagulopathies6-7 and no significant adverse anticoagulation effects were demonstrated in long-term studies (90-119 months) of oral pentosan polysulfate use in interstitial cystitis.8-9 Despite its limited bioavailability, coagulation monitoring with oral pentosan polysulfate has been suggested.1 This case demonstrates that the risk for a systemic anticoagulation effect secondary to oral pentosan polysulfate does truly exist. While our patient had received higher-dose therapy at 900 mg/d, this dose has not previously been associated with such an effect.1, 6-7 To our knowledge, our young patient represents the first reported case of a life-threatening pentosan polysulfate--induced coagulopathy, resulting in intubation and exposure to multiple blood products. With its increasing use in the management of interstitial cystitis, the importance of coagulation monitoring must be further emphasized in pentosan polysulfate--treated patients, particularly prior to invasive procedures or surgery.
So it is possible that someone taking Elmiron, injured in a car accident, for instance, could die from loss of blood due to taking this drug. It's possible. And that's just too high a price to pay for a chronic prostatitis / chronic pelvic pain syndrome medication.
:icon13:
