Drug Injury Watch

Xeljanz Side Effects Include Serious, Potentially Fatal Infections As Well As Blood Clots And Venous Thromboembolism

March 2020: UK Drug Regulator MHRA Issues Safety Guidance And New Measures To Minimize Risks For Certain Patients

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We have written about Xeljanz drug safety several times in the past, with an emphasis on the risk of Xeljanz-related blood clots. Recently, however, there was some attention directed to a clinical trial finding which shows Xeljanz increases infection risks, with pneumonia, cellulitis, herpes zoster, and urinary tract infections.

For some background on the Xeljanz-related blood clots issue, you can read our previous articles:

• "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism", posted in February 2019; and,
• "European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)", posted in November 2019.

In the March 2020 edition of their Drug Safety Update publication, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published this report, "Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections".

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Xel­janz

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As we are focusing in this article on the fact that Xeljanz increases infection risks, we limit our review to that aspect of the MHRA Xeljanz Drug Safety Update report. In relevant part, here is what is being pointed out:

[Xeljanz (tofacitinib)] is known to increase the risk of serious and fatal infections such as pneumonia, cellulitis, herpes zoster, and urinary tract infections. Existing advice contraindicates use of [Xeljanz (tofacitinib)] in patients with active infections, and advises healthcare professionals to consider the benefits and risks in patients with recurrent infections, a history of serious or opportunistic infection, or travel to areas of endemic mycoses, and in those who have underlying conditions that may predispose them to infection.

Study A3921133 showed incidence of non-fatal serious infections to be higher in patients with rheumatoid arthritis receiving [Xeljanz (tofacitinib)] than in those receiving a TNF inhibitor (see letter for study data). The risk of serious infections and fatal infections was further increased in older patients aged 65 years or older, as compared to younger patients (aged 50–64 years) – see letter for data.

We will continue to watch for significant Xeljanz drug safety developments in the medical literature and the drug regulatory realm.

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

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Lemtrada Cardiovascular Reactions Can Occur Within 1-3 Days Of Infusions In People Without Any Identifiable Risk Factors

Unpredictable And Potentially Fatal Immune-Mediated Reactions Can Occur Within Months And Up To At Least 4 Years After Lemtrada Treatments

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed its review of Lemtrada (alemtuzumab) in the treatment of multiple sclerosis patients. Significant Lemtrada safety findings include the early risks of cardiovascular events with Lemtrada use and Lemtrada-related thrombocytopenia around the time of infusion, as well as long-delayed immune-mediated reactions involving Lemtrada years after its use.

The MHRA issued its review document, "Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions", on February 12, 2020. Here are its Lemtrada safety findings as regards the risks of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada:

The review concluded that serious cardiovascular reactions can rarely occur within 1 to 3 days of [Lemtrada (alemtuzumab)] infusions in people without any identifiable risk factors. Reactions included myocardial ischaemia, cerebral haemorrhage, arterial dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage, and non-immune thrombocytopenia.

The review also found unpredictable and potentially fatal immune-mediated reactions can occur within months and up to at least 4 years after treatment with [Lemtrada (alemtuzumab)]. Reactions included autoimmune hepatitis, haemophagocytic lymphohistiocytosis, and acquired haemophilia A. The review also identified serious cases of Epstein-Barr virus reactivation reported after treatment, including hepatitis. Some patients developed more than one autoimmune disorder following treatment.

Lemtrada is a monoclonal antibody (mAb) authorized for the treatment of adults with relapsing-remitting multiple sclerosis.

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We have written several times previously about Lemtrada safety findings pointed out by the FDA and other drug regulatory agencies in the past couple of years:

• In December 2018 we published this article, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", which covered a November 2018 FDA Drug Safety Communication about Lemtrada.
• In July 2019 we published this article, "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation", to inform the MHRA had established new use restrictions and requiring increased monitoring of patients using this Lemtrada.
• In October 2019 we published this article, "Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers", which pointed out a study that found six additional deaths related to Lemtrada use that had not been reported before.

Soon after that last article, a "Dear Healthcare Professional Letter" was sent out by sanofi-aventis Canada Inc., "LEMTRADA (alemtuzumab) - Risk of Autoimmune Hepatitis, Haemophagocytic Lymphohistiocytosis, and Associated Serious Cardiovascular Reactions".

We will continue to monitor the medical literature for reports of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada.

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

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Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings

At Issue Is Dangerous Form Of Eye Inflammation, Occlusive Retinal Vasculitis, Which Can Lead To Vision Loss Or Blindness

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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.

To set the stage for this contention by Novartis about the Beovu package insert, or drug label, you may want to see our previous article about this emerging safety issue, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".

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As regards this recent Novartis statement about Beovu safety, we get the following information from a March 2, 2020 Fierce Pharma news report, "Novartis stands behind Beovu's safety, benefits after vision-loss warning":

“We believe the incidence of these events remains consistent with or below the package insert,” [Novartis] said in its [March 2, 2020 statement].

Most of the cases have started after patients’ first or second injection of the wet age-related macular degeneration (AMD) drug, Novartis said. The company has instructed doctors to advise patients to seek care immediately if they experience redness in the eye, light sensitivity, pain or changes in vision. The drug also shouldn’t be used in patients with intraoccular inflammation.

Aside from its own review, the company is working with its data monitoring committee for ongoing global trials of Beovu, and it's brought in an external review group to look at the cases. Drug authorities in the U.S., Europe, Switzerland and Australia know about the review, and Novartis said it’s getting in touch with other regulators.

Of course, we will continue to monitor this emerging Beovu safety issue and report significant developments here on Drug Injury Watch.

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)