free web stats

Law Offices of Thomas J. Lamb

New Elmiron Medication Guide Points Out Retinal Pigmentary Eye Problems

By

The new Elmiron Medication Guide mandated by the FDA Center for Drug Evaluation and Research (CDER) in March 2021 follows and reiterates the June 2020 Elmiron label change that added warning about the pigmentary maculopathy Elmiron side effect.

We point out that before the June 2020 Elmiron label change adding this new warning about the pigmentary maculopathy Elmiron side effect, the Elmiron drug label had stated “Warnings: None”.

As regards the pigmentary maculopathy Elmiron side effect, the new Elmiron Medication Guide includes the following:

Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms:

  • difficulty reading
  • your vision takes longer to adjust to low or reduced light
  • blurred vision

Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes….

As we have stated previously, the June 2020 Elmiron label change that finally added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy was overdue from our perspective. Accordingly, there have been Elmiron lawsuits filed by patients who have suffered vision loss against the pharmaceutical companies responsible for Elmiron.

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with retinal pigmentary eye problems such as the pigmentary maculopathy Elmiron side effect.

If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form — it is free, confidential, and there is no obligation.

[Read article in full at original source]

Elmiron

Free Case Evaluation

Strictly Confidential, No Obligation

Maculopathy Patients Should be Asked About Any Elmiron Use in Past

By

A new Elmiron medical study about cases of macular toxicity related to PPS exposure suggests that established maculopathy patients should be questioned regarding any Elmiron use in the past. This will help eye doctors determine whether this person may have Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity.

The findings of this new study about Elmiron maculopathy are presented in this article, “New Insights Into Pentosan Polysulfate Maculopathy”, posted on January 21, 2021, by the medical journal Ophthalmic Surgery, Lasers and Imaging Retina, or OSLI Retina.

From that January 2021 medical journal article about Elmiron maculopathy we get this background information set forth in its Introduction section:

Macular toxicity secondary to pentosan polysulfate sodium (PPS) (Elmiron; Janssen Pharmaceuticals, Beerse, Belgium) was first reported in 2018. PPS is the only U.S. Food and Drug Administration (FDA)-approved oral treatment for interstitial cystitis (IC), a painful urological condition affecting approximately 45 in 100,000 women and eight in 100,000 men globally.

A significant contribution of this new Elmiron medical study to the medical literature has to do with how one might diagnose Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity. From the Conclusions section of the January 2021 OSLI Retina article:

Patients with long-term [use of Elmiron, i.e., exposure to PPS] may present with various pre-existing diagnoses but most PPS toxicity cases manifest with a specific constellation of OCT, FAF, and [OCT angiography (OCTA)] findings. Established maculopathy patients should be questioned regarding exposure to PPS, especially with negative genetic testing or atypical presentations.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can submit an Elmiron Case Evaluation Form online or you can call us on our toll-free number: 800-426-9535.

[Read article in full at original source]

Elmiron

Free Case Evaluation

Strictly Confidential, No Obligation

Elmiron Legal Cases for Eye Damage and Retinal Injury Are Consolidated in Elmiron MDL

By

In December 2020, all Elmiron legal cases alleging eye damage and retinal injury filed in the federal courts were consolidated by means of an Elmiron MDL Order. These Elmiron legal cases are noteworthy as regards the monetary damages aspect of a lawsuit because these Elmiron-related eye problems can lead to vision loss or blindness.

From the Transfer Order issued for In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MDL Docket No. 2973, we get the following legal information:

After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]

Unlike most pharmaceutical drug injury lawsuits, for these Elmiron legal cases a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor. This is because there can be a delay, or latency period, from a patient’s Elimiron “exposure” until there is Elmirion “toxicity” causing eye damage and retinal injury.

If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send can submit an online Elmiron Case Evaluation Form or you can call us on our toll-free number: 800-426-9535.

[Read article in full at original source]

Elmiron

Free Case Evaluation

Strictly Confidential, No Obligation

Our Other Websites

DrugInjuryWatch.com

LambLawOffice.com

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com