Elmiron – Emerging Litigation

Elmiron – Focus blocks

Elmiron (pentosan polysulfate sodium (PPS)) is a medication used to treat discomfort or bladder pain associated with interstitial cystitis.

Manufacturer: ELMIRON is a Registered Trademark of IVAX Research, LLC under license to Ortho−McNeil−Janssen Pharmaceuticals, Inc.

Mechanism Of Action:

In IC, PPS is believed to work by providing a protective coating to the damaged bladder wall. PPS is similar in structure to the natural glycosaminoglycan coating of the inner lining of the bladder, and may replace or repair the lining, reducing its permeability.

Modes of Action: The fraction of pentosan polysulfate sodium that is absorbed is metabolized by partial desulfation in the liver and spleen, and by partial depolymerization in the kidney to a large number of metabolites. Both the desulfation and depolymerization can be saturated with continued dosing.

Excretion: Following administration of an oral solution of a 300 or 450 mg dose of pentosan polysulfate sodium containing radiolabeled drug to groups of healthy subjects, plasma radioactivity declined with mean half-lives of 27 and 20 hours, respectively. A large proportion of the orally administered dose of pentosan polysulfate sodium (mean 84% in the 300 mg group and 58% in the 450 mg group) is excreted in feces as unchanged drug. A mean of 6% of an oral dose is excreted in the urine, mostly as desulfated and depolymerized metabolites. Only a small fraction of the administered dose (mean 0.14%) is recovered as intact drug in urine.

Distribution: Preclinical studies with parenterally administered radiolabeled pentosan polysulfate sodium showed distribution to the uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow. Erythrocyte penetration is low in animals.

Approval: Elmiron has been approved as a treatment for the relief of pain and discomfort associated with interstitial cystitis (IC), a chronic, progressive and debilitating urinary bladder disease afflicting primarily women. IC is characterized by severe bladder and pelvic pain and urinary frequency.

Approval Date: 1996-10-01

Elmiron Warnings:

Between 1997 and 2019, 100 cases identified as “eye disorders” among Elmiron patients were filed with the FDA Adverse Event Reporting System (FAERS). Eighty of these were classified as serious. At least 22 of these reports mentioned some form of maculopathy.

Elmiron product labeling does not include any language describing pigmentary maculopathy or any other form of maculopathy. The only references to any form of ocular or vision-related disorders are located within the Adverse Reactions section, referring to nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage observed in premarket clinical trials. The labeling includes no relevant warnings and identifies no relevant adverse events observed in the post-marketing setting

Side Effects:

·         Macular degeneration

·         Pigmentary maculopathy

·         Retinal maculopathy

·         Alopecia (hair loss)

·         Bruising

·         Diarrhea

·         Gastroesophageal reflux

·         Headaches

·         Skin rash

·         Sleep disorders

 

Injuries to Consider Include:

·         Blurred vision

·         Degenerative maculopathy

·         Halo vision

·         Macular retinopathy

·         Macular/pattern dystrophy

·         Maculopathy

·         Metamorphopsia

·         Pigmentary maculopathy

·         Reduced night vision

·         Retinal pigment epithelium atrophy

·         Retinopathy

·         Scotoma

·         Unilateral or bilateral blindness

·         Vision impairment

·         Permanent vision loss

Warning By The Manufacturer:

CONTRAINDICATIONS: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

WARNINGS: None.

Case review focus areas:

1. Whether the patient was prescribed Elmiron? Reason for prescription??

2. Did the patient have any preexisting conditions, allergies or contraindications for Elmiron?

3. Dosage and Intake details (to be included under pharmacy log)

Critical Review of

Physician Drug Prescription Details

Pharmacy Dispensing Details

Pharmacy Refill Details

Details of Pharmacy Dispensing Details are taken as Confirmatory

4. What was the injury due to Elmiron?

  1. Treatment/management. Any complications
  2. Follow-up visits for treatment/management of injury.
  3. Outcome/prognosis. Resolution of injury?

Missing record communication:

Identify and report on missing medical records

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

What Records/Medical Bills are NeededHospital/ Medical ProviderDate/Time PeriodWhy we need the Records/BillsIs Record Missing Confirmatory or Probable?Hint/Clue that records are missing