Elmiron may no longer be Drug Companies’ Golden Goose

Santa Clara, CAIn a pharmaceutical manufacturer’s perfect world, patients will take their drug indefinitely to treat an ailment.  What Elmiron drug makers don’t want is a cure. And they don’t want the public to know about adverse side effects, such as vision loss.

What is Elmiron?

According to the Elmiron website published by Janssen Pharmaceuticals, pentosane polysulfate sodium (brand name Elmiron) is a blood thinner and is the only oral medication approved by the FDA to treat bladder pain caused by interstitial cystitis (IC). And it is approved for long-term use. Hence the golden goose.

Elmiron and the FDA Approval History

In 1991, Baker Norton Pharmaceuticals submitted a new drug application (NDA) for pentosane polysulfate sodium, but the FDA refused to approve the drug until Baker Norton submitted additional information. It sent more information and materials in 1993 but was still unapproved. And again the FDA issued a second non-approvable letter around 1994.

The FDA in 1995 designated Elmiron as an “orphan drug” which means it is granted special status to treat a rare disease or condition upon request of a sponsor. At that time, a study published in Food Chem Toxicol found “ very little data available addressing adverse effects of chronic consumption of Elmiron by patients undergoing therapy.”  In 1996 the agency approved Elmiron for relief of pain or discomfort associated with IC. At this time Elmiron did not come with any warnings or information regarding the risk of serious visual complications.

(Baker was purchased by Teva Pharmaceutical Industries, Ltd around 1997 and from July 2004 until August 2008, Ortho Pharma held the NDA for Elmiron. Since 2008 Janssen Pharma, held the NDA for Elmiron and continues to manufacture and/or distribute Elmiron in the U.S.)

Elmiron Lawsuits

Lawsuits claim Janssen Pharmaceuticals, under Johnson & Johnson, knew about the research linking Elmiron to vision loss since 2018, but failed to warn consumers of the dangers. According to the lawsuits, the drug company knew that taking Elmiron for more than six months increased the risk of vision loss.

A lawsuit filed in Alabama on behalf of plaintiff Audrey Howell (she was diagnosed with pigmentary maculopathy and other vision complications) states that the drug companies (above) knew of the “Elmiron Defect but Failed to Warn or Test. From approximately 1997 to the present, Defendants have received multiple Adverse Event Reports (“AER”) from medical professionals concerning Elmiron.”

The lawsuit cites several studies that raised concerns about Elmiron’s association with vision loss. “Since approximately 2018, outside, independent studies and reports, documented in medical literature raise similar concerns regarding Elmiron’s safety and propensity for causing serious visual complications including, but not limited to, pigmentary maculopathy.”

It goes on: By approximately 2001, Defendants had reasonable evidence of a causal association between serious vision-related injuries and Elmiron…could cause serious vision-related injuries; Defendants knowingly withheld and/or misrepresented information required to be submitted under FDA NDA regulations, concerning the safety and efficacy of Elmiron.”

Will Elmiron’s profits outweigh the cost of litigation?

Sales of Elmiron generate approximately $150 million in annual revenue in the U.S. alone, but reports of serious visual side effects have morphed into lawsuits and this stream of steady profit for Jannsen and Teva Pharmaceuticals may have an ending.