Drug Injury Watch

Lemtrada ANCA-Associated Systemic Vasculitis Case Report Presented In Recent Medical Journal Article

Lemtrada Side Effects Range From Drug-Induced Autoimmune Complications To Cardiovascular Reactions

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Medical researchers in Switzerland recently presented the case of a 26-year-old man who developed life-threatening anti-neutrophil cytoplasmic autoantibody (ANCA) systemic vasculitis after being treated with Lemtrada (alemtuzumab) for relapsing-remitting multiple sclerosis. This case report about Lemtrada causing ANCA-associated vasculitis adds to the growing number of autoimmune complications which can be regarded as Lemtrada side effects.

This medical article about Lemtrada, "ANCA-associated life-threatening systemic vasculitis after alemtuzumab treatment for multiple sclerosis", was published February 21, 2020 by the Multiple Sclerosis Journal. From the Abstract for this article:

Lemtrada (alemtuzumab) is highly effective in relapsing remitting multiple sclerosis (RRMS), but autoimmune adverse events are of concern. In contrast to rare cases of immune-mediated cutaneous vasculitis, systemic vasculitis after alemtuzumab has not yet been described. We report the case of a 29-year-old man with RRMS who developed fever, auricular chondritis, cutaneous vasculitis and life-threatening diffuse alveolar haemorrhage, 12 months after Lemtrada (alemtuzumab). Antibodies to myeloperoxidase appeared 9 months after Lemtrada (alemtuzumab) and were extremely high at the time of vasculitis. Outcome was favourable after glucocorticoids, plasma exchanges and rituximab. Thus, Lemtrada (alemtuzumab) may induce life-threatening vasculitis in patients treated for RRMS.

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Anti-neutrophil cytoplasmic autoantibody (ANCA) vasculitis is an autoimmune disease that causes blood vessels to swell. Several types of ANCA vasculitis exist due to numerous causes, so patients diagnosed with ANCA vasculitis may display varied symptoms.

We have written several articles about Lemtrada side effects over the past couple of years, with the most recent one being "Lemtrada Cardiovascular Reactions Can Occur Within 1-3 Days Of Infusions In People Without Any Identifiable Risk Factors", which we posted in March 2020.

We will monitor the medical literature for possible other reports of Lemtrada causing ANCA-associated vasculitis as well as other more well-established Lemtrada side effects.

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

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Picato Skin Cancer Risk Findings Are Confirmed By European Drug Safety Panel In April 2020

FDA Investigation Of This Picato Drug Safety Issue Seems To Be Still Ongoing, Despite Picato Recall In Europe

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A European drug safety panel announced in April 2020 that Picato increased risk of skin cancer findings outweigh Picato's benefits as a treatment of actinic keratosis. On January 27, 2020 we posted this article, "Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe", which provides some background for this Picato drug safety issue.

As regards this new development, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) noted a higher occurrence of skin cancers in areas treated with Picato (ingenol mebutate) than in areas of skin treated with another actinic keratosis treatment, imiquimod. It also noted that Picato’s benefit is not maintained over time and that other treatment options are available.

The Picato increased risk of skin cancer findings were further explained in this April 17, 2020 European Medicines Agency press release, "EMA review of Picato concludes medicine’s risks outweigh its benefits":

The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod.

The [PRAC] also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis....

Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist.  [emphasis added]

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As mentioned in our January 2020 article about this Picato skin cancer risk, at that point in time the FDA was gathering data and information to investigate this Picato drug safety issue.  Therein we referenced a Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020:

"This matter does not affect Picato in the U.S., and there are no new developments in the [United States]. Picato continues to be available to patients in the U.S...." Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email.

The FDA "is gathering data and information to investigate the safety concern related to Picato," a spokesperson for the FDA told Dermatology News. "We are committed to sharing relevant findings when we have sufficient understanding of the situation and of what actions should be taken," he added.

We will monitor the FDA Picato skin cancer risk investigation and report any significant drug regulatory actions on our Drug Injury Watch site.

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

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Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report

This Is A Reversal Of March 2020 Novartis Position That Current Beovu Drug Label Provided Sufficient Warnings

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

According to an April 2020 news report, Novartis has said it will work with FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu vision-related side effects.  There have been reports of severe vision loss associated with Beovu injections as well as cases of vasculitis linked to Beovu.

In March 2020 Novartis had stated that the current Beovu Prescribing Information document sufficiently addressed Beovu risks of intraocular inflammation and retinal artery occlusion.

From this April 9, 2020, BioPharma Dive news report about Beovu, "Eye drug side effects are real, Novartis confirms in new warning", we get the following:

Arterial blockages, blood vessel inflammation or severe vision loss were reported about 10 times for every 10,000 injections in March, Novartis said. The pharma will ask the Food and Drug Administration and other regulators to add new information to the product label, which could result in a "black box" warning....

In its new review of post-market adverse events reporting, Novartis found retinal artery occlusion, inflammation of blood vessels in the eye —​ known as vasculitis ​—​ or severe vision loss occurred in 8.75 to 10.08 out of 10,000 injections for five weeks spanning Feb. 28 to March 27.

Events causing severe vision loss such as uveitis or cataracts were most common, occurring at a rate of as high as 4.03 per 10,000 injections in the week of March 6.

Further, BioPharma Dive reporter Jonathan Gardner included this comment by RBC Capital Markets analyst Kennen MacKay in that news report:

RBC's MacKay wrote that the cases of severe vision loss and vasculitis should draw the most scrutiny from the FDA, because they haven't been reported with Eylea and other drugs using the same biological pathway such as Roche and Novartis' Lucentis and Roche's Avastin, which is used off-label.

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Last month, in this article about Beovu, "Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings", we presented the previous position taken by Novartis about Beovu vision-related side effects:

On March 2, 2020 Novartis stated that the current Prescribing Information document for its macular degeneration drug Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. This Novartis statement about a recent Beovu safety issue is in response to a notification for eye doctors issued last week by the American Society of Retina Specialists about 11 case reports of Beovu-associated occlusive retinal vasculitis, which can lead to vision loss or blindness.

It was during February 2020 that the first news reports about the Beovu risks of intraocular inflammation and retinal artery occlusion surfaced, which we presented in this earlier article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".

We will watch to see if and when Novartis issues a revised Beovu drug label with new warnings in the US, Europe, and elsewhere around the world.

We are investigating cases of severe vision loss associated with Beovu and cases of vasculitis linked to Beovu as possible drug injury lawsuits that could be filed against Novartis.

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)