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FDA Warns Bladder Pain Relief Drug (Elmiron) Causes Serious Eye Damage

Attention Consumers: The bladder pain drug Elmiron causes vision problems, eye disorders, and blindness in many users. Even short-term use of Elmiron can cause grave problems for patients. The drug Elmiron is used to treat Interstitial Cystitis, which is a chronic condition that causes bladder pressure, bladder pain and sometimes pelvic pain. Interstitial Cystitis is part of a spectrum of diseases known as painful bladder syndrome and mostly affects women. The pain ranges from mild discomfort to severe pain and the condition can often lead to frequent urination. Interstitial cystitis (IC) is a painful urinary tract condition affecting millions of Americans, and Elmiron is the only FDA-approved drug to treat it. This means that patients with IC might not be able to obtain an alternative for their pain.

Doctors who have studied Elmiron are strongly recommending that patients undergo eye imaging while taking Interstitial Cystitis drugs to check for the presence of maculopathy. It is suggested that patients who find maculopathy to be present should immediately stop taking the drug.

Medicines are thought to bring healing. We think of pills as taking away our pain, driving away illness and restoring us to good health. Elmiron is one such drug—it was approved by the FDA to treat painful bladder conditions, but causes vision loss and blindness.

Patients who have taken Elmiron have reported the following symptoms:

  • Blindness
  • Vision loss
  • Blind spots
  • Distorted vision
  • Blurred vision
  • Difficulty reading
  • Difficulty adapting to dim light
  • Dark spots in vision
  • Less bright colors

The FDA Approves New Warning Label for Elmiron

On June 16, 2020, the FDA approved a changed label for Elmiron warning of the drug’s dangerous side effects. The drug’s manufacturer, Janssen Pharmaceutical Companies, revised the label to include “Retinal Pigmentary Changes” under the “Warnings” section.

This change, however, comes too late. The manufacturers included similar warnings in Canada in October, 2019 and in Europe as early as June 2019. They took much longer to warn the American public about the risks associated with even short-term use of Elmiron.

Before the label was changed, Janssen and its parent company Johnson & Johnson only mentioned hair loss, diarrhea, nausea, and headaches as potential side effects. Even now, the label is not as effective as a black box warning, the most stringent FDA warning. Given the risk of permanent blindness associated with Elmiron use, even stronger measures need to be taken against the manufacturers of the drug.

Now that the Food and Drug Administration also approved a label change for the drug, outlining risks and side effects so that users are warned about the dangers of taking Elmiron. This, however, is not enough to protect patients from a drug as harmful as Elmiron.

Janssen Pharmaceuticals had the obligation to warn Elmiron users about the drug’s potentially life-altering side effects. It failed in its duty toward consumers and must be held accountable for its careless actions. Those harmed by the drug have a right to compensation for the negligence that has resulted in life-long pain and suffering.

The network of attorneys at Consumer Coalition have vast experience holding big corporations accountable for concealing the true dangers of consumer products. Consumer Coalition intends to hold the Janssen Pharmaceuticals accountable marketing a drug like Elmiron that has damaged eyes beyond repair. Across all areas of practice, they have successfully obtained billions of dollars in verdicts and settlements on behalf of our attorneys' clients.

If you have used Elmiron and are now suffering from any eye disorder, you deserve to be compensated for your pain. The network of attorneys at Consumer Coalition have counselled many clients in drug-related cases and they have successfully obtained billions of dollars in verdicts and settlements on behalf of our attorneys' clients.

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