Health Canada Updates Elmiron Vision Loss Related Warnings

Health Canada Updates Elmiron Vision Loss Related Warnings

Introduction

On December 15, Health Canada, the department of the Government of Canada responsible for the country's federal health policy, released a report titled Dear Healthcare Professional Letter, indicating that the drug used for the treatment of interstitial cystitis (IC) should not be used by individuals with a history of macular disease.

Elmiron, also known by its generic name pentosan polysulfate sodium (PPS), is a medication prescribed to treat IC. Several cases of pigmentary maculopathy, which involves changes to the retina, causing vision loss and impairment, have been reported among its users, mostly by individuals who have been using it for three years or longer.

Several studies and a growing number of lawsuits filed in recent years claimed that long-term exposure to Elmiron has serious eye-related side effects and causes maculopathy, an eye disorder affecting the macula, central part of the retina, which is a major cause of blindness. Many experts have referred the retinal disease to “Elmiron maculopathy” or “PPS maculopathy.” It is also a weak blood thinner and, therefore, may increase the risk of bruising/bleeding.

According to the letter, along with the new contraindication information, the Canadian Product Monograph for the drug has also been updated to strengthen the information about the associated risks.

The key messages noted in the letter for healthcare professionals are:

• Assess the benefits and risks with the patients before initiating treatment with Elmiron and periodically thereafter.
• Obtain a detailed ophthalmologic history of all patients before starting treatment with Elmiron.
• Perform baseline and regular retinal examinations for early detection of macular pathology.
• Counsel patients to report changes in vision, such as difficulty reading, slow adjustment to low or reduced light, blurred vision, including blurry or wavy vision near or in the center of the field of vision.

The letter also asks healthcare professionals and consumers to report any case of pigmentary maculopathy or other serious or unexpected side effects associated with the drug to Janssen Inc. or Health Canada.

In the U.S., a couple of weeks ago, the United States Judicial Panel on Multidistrict Litigation (JPML) centralized the growing number of Elmiron lawsuits in the District of New Jersey for coordinated pretrial proceedings, which will be monitored by Honorable Brian R. Martinotti.

Currently, more than 100 product liability lawsuits are pending in the U.S. against Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceuticals, Inc., each claiming that its users suffered severe retina damage and permanent vision problems, including difficulty adapting to the dark light, spots, or floaters in the vision and complete blindness.