Drug Injury Watch

Uloric Use By Patients With Major Cardiovascular Disease Associated With Higher Risk Of Deaths

New Drug Safety Warning: Uloric Should Be Avoided When There Is Prior Myocardial Infarction, Stroke, Or Unstable Angina

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

From this Drug Safety Update issued July 17, 2019 by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), "Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease", we get the following new Uloric warning:

Avoid treatment with [Uloric (febuxostat)] in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to [Uloric (febuxostat)] than in those assigned to allopurinol.

In Europe, a so-called "Dear Doctor Letter" about Uloric side effects was sent out in late June 2019 by the drug company responsible for Adenuric, i.e., Uloric, in agreement with the MHRA and the European Medicines Agency (EMA).

The CARES study -- or the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial -- was conducted as an FDA requirement to determine whether Uloric was noninferior to allopurinol, a long-used gout drug, with regard to major cardiovascular events in patients with gout and cardiovascular disease.

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Uloric

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We have written previously about Uloric causing cardiovascular death, sudden cardiac arrest or sudden cardiac death, heart failure, myocardial infarction or heart attack, stroke, unstable angina with urgent coronary revascularization, and other heart-related problems.

Our three most recent articles from earlier this year are:

• Uloric Lawsuits Involving Heart Attacks And Strokes Follow Recent FDA Warnings About Cardiovascular Deaths (April 2019)
• Uloric "Black-Box Warning" For Increased Risks Of Heart-Related Deaths And Cardiovascular Side Effects (March 2019)
• Uloric Recall, "Black-Box Warning", And Limited Use Discussed By FDA Advisory Committees In January 2019 (January 2019)

Our law firm is investigating possible Uloric lawsuits where patients have suffered cardiovascular Uloric side effects as personal injury cases or wrongful death claims, depending on the outcome.

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)

Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation

UK Drug Safety Regulator MHRA Imposes Lemtrada Use Restrictions And Mandates Patient Monitoring For Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In May 2019 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) took regulatory action regarding Lemtrada establishing new use restrictions and requiring increased monitoring of patients using this multiple sclerosis (MS) drug.

From the introductory part of this May 17, 2019 MHRA Drug Safety Update, "Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements", we get this summary:

While an urgent [European Union (EU)] safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.

For some background on the EU safety review of Lemtrada mentioned above, we refer you to our April 2019 article "Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients".

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Lemtrada

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Returning to the May 2019 Lemtrada Drug Safety Update from the UK's MHRA, we have compiled this list of serious side effects which have been reported in MS patients using Lemtrada "particularly within 3 days of dosing":

Cases of cardiovascular reactions

• Pulmonary hemorrhage
• Myocardial infarction
• Arterial dissection
• Stroke (hemorrhagic and ischemic)

Cases of immune-mediated disorders

• Autoimmune hepatitis
• Hemophagocytic lymphohistiocytosis

We will continue to watch for reports of serious cardiovascular events and immune-mediated reactions involving Lemtrada.

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)