JANSSEN PHARMACEUTICAL COMPANIES, A SUBSIDIARY OF JOHNSON & JOHNSON, NOTES IN ITS LABEL THAT ELMIRON USERS SHOULD BE INFORMED THAT CHANGES IN VISION SHOULD BE NOTED AND EVALUATED
NEW YORK – In the background of mounting litigation, drug manufacturer, Janssen Pharmaceutical Companies, a subsidiary of drug giant, Johnson & Johnson, has just made a dramatic label change in the United States to its bladder pain drug, Elmiron®. Though prior labeling in the United States previously listed no risks under the “Warnings” section, the revised label now indicates “Retinal Pigmentary Changes”. The FDA approved the label change on June 16, 2020. However, Canadian authorities had required such warnings for Elmiron in October 2019, while the European Medicines Agency demanded a warning in the label as early as June 2019. These retinal changes, reported as pigmentary maculopathy, were identified with long-term use of the drug in the new warning, though Janssen also warned that these changes have been seen with shorter durations of use as well. Janssen has now conceded to United States users of Elmiron® that a cumulative dose of Elmiron® “appears to be a risk factor.”
Pigmentary maculopathy is a serious eye condition that affects the retina. It may cause, among other conditions, night blindness or total blindness, difficulty reading, difficulty acclimating to dim lighting and partial or full loss of vision. Pigmentary maculopathy caused by Elmiron is irreversible and can progress even when the drug is discontinued. Prior to this label change, Johnson & Johnson and Janssen assured consumers that the only side effects to using Elmiron® were minor ailments such as hair loss, diarrhea, nausea, and headache.
Elmiron® is a weak blood thinner (anticoagulant) used to treat bladder pain or discomfort caused by cystitis of the bladder. It is the only oral medication approved by FDA for Interstitial Cystitis (also known as “bladder pain syndrome” or IC/BPS.) However, due to the disabling nature of the damage Elmiron can cause, including the severity of this maculopathy resulting in total vision loss in some cases, one wonders why FDA did not require these new warnings to be in the form of a “black box warning”. A black box warning is the FDA’s most stringent warning for drugs and medical devices on the market. “Black box warnings”, or boxed warnings, alert the public and health care providers to serious side effects, such as injury or death.
Parker Waichman LLP, a national law firm, has been actively involved in Elmiron® litigation. A copy of the updated Elmiron label is available on our website.
Parker Waichman has been litigating cases involving dangerous drugs and medical devices that cause serious and permanent injuries to the eyes for more than a decade. Those wishing to pursue an Elmiron® lawsuit should contact Parker Waichman without delay and speak to one of its pharmaceutical attorneys for a free consultation. There is no obligation and there will be no fee for the firm’s services unless the client receives compensation from the Elmiron® lawsuit. Parker Waichman can be reached at 1-800-YOURLAWYER (1-800-968-7529).
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