Drug Injury Watch

Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections

November 2020 Report: Beovu Eye Side Effects Risks Higher for Beovu Patients with Prior Intraocular Inflammation and/or Vascular Occlusion

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We have known since early 2020 that Beovu treatments may be associated with intraocular inflammation, with or without retinal vasculitis, which can lead to Beovu patients developing vision loss. In mid-November 2020 Novartis announced the initial findings of a "coalition" established by Novartis to examine the root causes and potential risk factors for these adverse events associated with Beovu injections.

From this November 14, 2020, Reuters new report, "Novartis identifies possible risk factors for Beovu patients", we get the latest information about eye side effects associated with Beovu injections:

Patients who had certain eye problems before they were treated with Novartis’s Beovu had a higher risk of suffering from vision-threatening conditions after treatment, the Swiss drugmaker said on Saturday, based on a safety review.

The review follows a warning issued by the American Society of Retinal Specialists in February about instances of intraocular inflammation, some of which led to severe vision loss, in patients using Beovu....

According to Novartis’s review, among 12,000 patients treated with Beovu, the highest observed risk for experiencing retinal vasculitis and/or retinal vascular occlusion in the six months after first treatment was prior intraocular inflammation and/or vascular occlusion in the 12 months before the first Beovu injection.

The observed overall risk rate of 0.46% for all Beovu-treated patients increased to 3.97% in people who had the conditions before treatment, Novartis said.

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We get additional information about Beovu patients developing vision loss from an article published by Healio Ophthalmology, "ReST committee provides update on brolucizumab", on November 15, 2020:

[Beovu (brolucizumab)] injections may be associated with intraocular inflammation, with or without retinal vasculitis, and patient selection should take this into account, according to a speaker.

"Intraocular inflammation alone may often be managed with topical steroids, but optimal treatment for vasculitis remains unknown. This post-approval analysis is unable to assess rates or long-term outcomes, and further studies are indicated,” Paul Hahn, MD, said at Retina Subspecialty Day at the virtual American Academy of Ophthalmology meeting.

The American Society of Retina Specialists Research and Safety in Therapeutics (ReST) committee began to receive reports of intraocular inflammation alone and retinal vasculitis in patients who underwent injections of Beovu (brolucizumab, Novartis) following its FDA approval for neovascular age-related macular degeneration in October 2019. To date, the committee has received 120 reports, Hahn said.

In a subset of patients through May 2020, the committee received reports of intraocular inflammation alone in 49 eyes of 45 patients. The inflammation was typically mild to moderate in the anterior chamber and vitreous, often appearing in both, but more commonly with posterior involvement. Vision loss was relatively modest, often returning to baseline levels, and most patients were treated with topical steroids, he said.

Through April 2020, the committee received reports of retinal vasculitis in 26 eyes of 25 patients. These patients showed a more precipitous loss of vision that did not recover, with 46% of eyes losing more than three lines of vision and 35% of eyes losing more than six lines of vision, he said.

To date, case reports of adverse events associated with Beovu treatments indicate that retinal vasculitis and/or retinal vascular occlusion can occur as early as the first or second injection of Beovu. Further, some Beovu patients are reporting severe vision loss or other changes in vision within one to two weeks of their Beovu injections.

We are investigating possible Beovu drug injury lawsuits against Novartis for patients who suffered vision loss following their Beovu treatments.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant

European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A recent periodic review of Gilenya safety data by the European Medicines Agency (EMA) has turned up cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.  That new Gilenya safety information was presented in this EMA periodic safety update report, "Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)", published November 10, 2020.

As regards the cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya, from the Direct Healthcare Professional Communication (sometimes called a "Dear Doctor" letter) document included in the November 2020 EMA periodic safety update report for Gilenya we get the following details:

Following the most recent periodic review of safety data, three cases of liver failure requiring liver transplant have been reported in patients treated with [Gilenya (fingolimod)], including one case implying a strong causal relationship with [Gilenya (fingolimod)]. Cases of clinically significant liver injury have also been reported. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose and have also been reported after prolonged use.

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In that November 2020 "Dear Doctor" letter about Gilenya, we get this guidance for physicians treating multiple sclerosis (MS) patients with Gilenya:

Hepatic enzyme increased is a very common adverse drug reaction of [Gilenya (fingolimod)] but due to the seriousness and the severity of recent reported cases, recommendations for discontinuation of the therapy and monitoring have been strengthen and clarify to minimize the risk of DILI. Bilirubin should be checked together with liver transaminase enzymes and liver tests function should be performed regularly until 2 months after [Gilenya (fingolimod)] discontinuation. In case of symptoms suggestive hepatic dysfunction, [Gilenya (fingolimod)] should be discontinued if significant liver injury is confirmed and treatment should not be resumed unless a plausible alternative aetiology for the signs and symptoms of liver injury can be established.

We will continue to monitor the Gilenya safety profile with special attention to cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)