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Parker Waichman LLP Comments On JAMA Opthamology's Articles Noting Findings Of Long Term Medical Consequences Related To Patient Use Of Interstitial Cystitis Medication Elmiron®


News provided by

Parker Waichman LLP

Jul 14, 2020, 11:38 ET

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PORT WASHINGTON, N.Y., July 14, 2020 /PRNewswire/ -- Parker Waichman LLP, a national law firm that has long fought to protect the rights of victims injured by allegedly defective drugs and defective medical devices, notes that Elmiron® (Pentosan Polysulfate Sodium) patients must be aware of the potential long-term consequences of Elmiron® use for a patient's vision, even after discontinuing use of Elmiron® according to a new study published in JAMA Ophthalmology on July 9, 2020. 

According to the JAMA journal article,  new data suggests Elmiron® associated maculopathy potentially "continues to evolve after drug cessation" and "[i]n some cases, progressive RPE atrophy may encroach on the central fovea years after drug cessation.". The study, conducted by Dr. Neeraj Jain at Emory University in Atlanta, Georgia and others, looked at eleven patients who had previously taken Elmiron for Interstitial Cystitis for a number of years and were diagnosed with toxicity of the retina related to their use of the drug.  Each of the eleven patients had stopped taking Elmiron® at some point in their history with one patient having ceased their use of the drug for approximately 10 years.  The goal of the retrospective review was to assess the effects of Elmiron® toxicity after cessation of use. 

The results of the study were quite startling and represent an important finding for both patients who have taken or continue to take Elmiron®, as well as physicians who continue to prescribe the drug.  The fact that nearly all of the eleven patients showed continued progression of their disease on ophthalmological imaging even after discontinuing use of Elmiron® is concerning.  A commentary authored by different physicians  which appeared in the same edition of JAMA Ophthalmology echoed this sentiment in stating that "[t]hese novel observations illuminate an important and concerning facet of the natural history of PPS maculopathy...".  The commentary went on to further recommend that physicians should counsel their patients that Elmiron "…involves a risk of permanent sight loss; the safe dosage, duration of therapy, and cumulative dosage limits remain unknown with respect to the risk of maculopathy; pre-symptomatic disease may not be easily detectable in the absence or implementation of formal screening procedures; and following the observations in this study, sight threatening maculopathy is likely to progress even if the drug is stopped."

Parker Waichman LLP filed suit last week United States District Court for the Southern District of California, against Bayer Healthcare Pharmaceuticals, Inc., Johnson & Johnson, Janssen Pharmaceuticals, Inc., Ortho-McNeil Pharmaceuticals, Inc. and others on behalf of Joanne Jackson, a San Diego resident and long-time user of the drug Elmiron®, who now suffers from retinal damage, pigmentary maculopathy and vision loss as a result of her use of the medication.  See Jackson, et al. v. Bayer Healthcare Pharmaceuticals, Inc., et al., Docket No. 20CV1266 JM.  The suit alleges defendants Bayer Healthcare, Johnson & Johnson, Janssen Pharmaceuticals, and Ortho-McNeil Pharmaceuticals, as well as other companies involved in the development, manufacture, and sale of the drug, failed to warn, advise, educate or otherwise inform not only Elmiron® users and potential users, but also physicians and governmental regulators in the United States, about the risk of damage to the patient's eyes.  Those risks included impaired vision, retinal damage, maculopathy and the need for medical, ophthalmological testing or monitoring.

Filing an Elmiron® Lawsuit

Parker Waichman LLP has represented clients in injury lawsuits for decades. If you or someone you know is interested in filing an Elmiron lawsuit, please contact Parker Waichman LLP at the firm's website at www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

SOURCE Parker Waichman LLP

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