Drug Injury Watch

Uloric Lawsuits Involving Heart Attacks And Strokes Follow Recent FDA Warnings About Cardiovascular Deaths

February 2019 Uloric Label Changes Include New "Black-Box Warning" To The Effect That Uloric Is Gout Drug Of Last Resort

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

As a result of recent FDA-mandated label changes for Uloric there have been lawsuits filed against Takeda Pharmaceuticals America, Inc., the manufacturer of Uloric. Those drug injury lawsuits allege that the drug company Takeda failed to warn Uloric users about the increased risks of heart attacks and strokes.

Uloric (febuxostat) tablets have been generally prescribed for the management of chronic gout since 2009.

In March 2019 we posted this article, "Uloric 'Black-Box Warning' For Increased Risks Of Heart-Related Deaths And Cardiovascular Side Effects".

This previous article explained that while there was no Uloric recall ordered, in February 2019 the FDA required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, for the Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric.

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In addition to this new Black-Box Warning for Uloric, the FDA required Takeda to make the following label changes:

1. Modify the "Indications and Usage" part of their Uloric drug label; and,
2. Add a new section (5.1) titled "Cardiovascular Death" to the "Warnings and Precautions" part of their Uloric drug label, which includes this language:

   Physicians and patients should remain alert for the development of adverse [cardiovascular (CV)] event signs and symptoms. Patients should be informed about the symptoms of serious [cardiovascular (CV)] events and the steps to take if they occur.

For more background on this relatively new Uloric drug injury litigation, you can read our earlier articles about Uloric:

• "Uloric Recall, 'Black-Box Warning', And Limited Use Discussed By FDA Advisory Committees In January 2019"  (January 2019)
• "Gout Drug Uloric Recall By FDA Requested In June 2018 Public Citizen Petition Letter"  (July 2018)
• "Uloric Drug Safety Update: A Significantly Higher Risk Of Death Among Patients Using Gout Drug Uloric As Opposed To Allopurinol"  (March 2018)
• "Gout Medicine Uloric Safety Trial Shows Increased Risk Of Heart-Related Deaths According To November 2017 FDA Alert"  (November 2017)

Our law firm is investigating possible Uloric cases involving patients who have suffered cardiovascular problems while taking Uloric. If we can be of assistance to you or someone else as regards a personal injury or wrongful death Uloric lawsuit, you can submit an online Case Evaluation Form or call us toll-free: 800-426-9535.

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 done by attorney Tom Lamb)

Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients

EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We recently learned by means of this April 12, 2019 European Medicines Agency (EMA) press release, "Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing", that the multiple sclerosis (MS) drug Lemtrada (alemtuzumab) is facing more scrutiny from drug regulators.

As background, we reported in this December 4, 2018 post, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", that in November 2018 an FDA Drug Safety Communication was issued and there was a Lemtrada label change, which included an increased risk of strokes warning being added to the "Black-Box Warning" for Lemtrada.

From this April 14, 2019 Medscape article, "PRAC Restricts Use of Alemtuzumab for MS Pending Ongoing Review", we get these details about the latest drug safety issues associated with Lemtrada:

New reports of serious side effects affecting the heart, blood vessels, lungs, and liver of patients with relapsing-remitting multiple sclerosis (MS) who are taking [Lemtrada (alemtuzumab)] have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a review and to place temporary restrictions on use of the drug while the review is ongoing.

In addition to the restrictions, PRAC has recommended an update of the product information for [Lemtrada (alemtuzumab)] to inform patients and healthcare providers about cases of immune-mediated conditions, including autoimmune hepatitis and hemophagocytic lymphohistiocytosis; problems with the heart and blood vessels that occur within 1 to 3 days of treatment, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection; and severe neutropenia.

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Returning to the April 2019 EMA press release about their Lemtrada safety investigation, we get the following from the "Information for patients" section:

• New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.
• You should get medical help immediately if you experience symptoms of:

-- acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
-- bleeding in lungs: such as trouble breathing and coughing up blood
-- stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
-- liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
-- an inflammatory condition known as haemophagocytic lymphohistiocytosis: such as fever, swollen glands, bruising and skin rash.

Looking forward, the PRAC’s final recommendations about Lemtrada will be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for their consideration.

We will continue to monitor drug regulatory actions regarding Lemtrada in the US, Europe, and elsewhere.

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 done by attorney Tom Lamb)

Zelnorm Approved By FDA (Again) In 2019 – Despite Zelnorm Being Removed From Market In 2007 For Safety Concerns

Concerns About Potential Cardiovascular Safety Signal As Well As Suicidal Ideation And Behavior Were Involved With Zelnorm Recall

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In October 2018 we wrote this article, “Waiting To See Whether FDA Approves Zelnorm In 2018 After Zelnorm Was Withdrawn In 2007 For Safety Reasons”, in which we asked this question:  Despite a possible benefit to some limited patient population, is allowing Zelnorm back on the market really warranted in view of the serious and still-lingering drug safety concerns?

While we had to wait until April 2019 to get the answer, it turned out our FDA thinks the answer should be “Yes”, and so it is.

For some details about Zelnorm being allowed back on the US market 12 years after there was an FDA-mandated Zelnorm recall, we turn to this April 2, 2019 Medscape article, “FDA OKs Reintroduction of Tegaserod (Zelnorm) for IBS-C in Women Under 65”.

[Zelnorm (tegaserod)] for [irritable bowel syndrome with constipation (IBS-C)] has had a checkered past. The drug was first approved by the FDA in 2002 for the short-term treatment of women with IBS-C. It was suspended from the US market in March 2007 due to potential cardiovascular (CV) safety concerns.

In July 2007, the FDA announced that it would allow restricted use of the drug for IBS-C and chronic idiopathic constipation in women younger than 55 years with no history of heart problems.

Last October, following a safety review, the FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended overwhelmingly (11 yes, 1 no) to recommend reintroducing tegaserod for IBS-C in women without a history of CV ischemic disease and who have no more than one risk factor for CV disease.

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From this April 3, 2019 Healio article, "FDA approves reintroduction of Zelnorm for IBS-C in certain women", we get this significant point:

Sloan Pharmaceuticals [(the responsible drug company)], a subsidiary of U.S. WorldMeds, acknowledged in [a press release] that there remains an increased risk for cardiac events, including myocardial infarction and stroke, when using [Zelnorm (tegaserod)].

For more background on this recent development, you can read our above-referenced October 2018 article about whether the FDA should allow Zelnorm back on the market and whether this would be a good idea as regards the matter of drug safety.

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 done by attorney Tom Lamb)