Drug Injury Watch

Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018

In Comparison, This December 2017 Regulatory Action By FDA In The US: "new class warning... for all gadolinium-based contrast agents"

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

There seems to be a consensus among the United States FDA and the United Kingdom MHRA drug safety agencies that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-based contrast agents (GBCAs) for months to years after receiving these drugs. 

Another point of agreement between those agencies is that certain linear GBCAs -- such as Magnevist, Omniscan, and OptiMARK -- result in more gadolinium retention in the body than macrocyclic GBCAs.

There is a difference, however, between FDA and MHRA in terms of the regulatory actions being taken with respect to this class of drugs, now.

On December 14, 2017 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this document, "Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents", which includes the following statement:

There is currently no evidence that gadolinium deposition in the brain has caused adverse neurological effects in patients; however, licences for gadodiamide (Omniscan) and intravenous gadopentetic acid (also known as gadopentetate dimegulumine; Magnevist) will be suspended from 1 February 2018 and these products will be recalled.

Further, this MHRA document points out that "One linear agent, gadoversetamide (OptiMARK), has been withdrawn by the Marketing Authorisation Holder and is not available in the UK."

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In comparison, at the present time FDA is only requiring that there be certain changes made to the Prescribing Information, or drug label, of all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) in the US.  To be clear, none of these products will be recalled from the market here.

On December 19, 2017 this document was issued, "FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings".

This document is an update to the May 22, 2017 MedWatch safety alert "Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention".

From the December 2017 FDA Drug Safety Communication:

To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.

We are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available....

Accordingly, we will be watching for any future recommendations from the FDA's Medical Imaging Drugs Advisory Committee about further label changes or regulatory actions for gadolinium-based contrast agents, especially Magnevist, Omniscan, and OptiMARK, here in the US.

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In The Shadow Of Recent Announcement About Diabetes Drug Jardiance Medical Study Results There Lingers Safety Concerns For SGLT-2 Inhibitors

As With Invokana and Farxiga, Jardiance Is Subject Of Several Drug Regulatory Agency Investigations About Ketoacidosis And Other Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Health Canada Warns About Link Between DKA & Popular Diabetes Drugs"

(5/19/16)

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Jardiance is part of the Sodium-Glucose Co-Transporter-2 (SGLT-2) Inhibitors class of diabetes drugs, which also includes Invokana and Farxiga. 

These new SGLT-2 diabetes medications -- which are distinctive from other diabetes drugs insofar that they make the kidneys extract a significant amount of sugar from the blood to be excreted in urine -- are prescribed to treat Type-2 diabetes.

Unfortunately, over the years Type 2 diabetes has become much more common, in part due to the so-called obesity epidemic here in the US. About 95 percent of the nearly 30 million American adults and children -- which is almost 10 percent of the current US population -- have Type 2 diabetes. And approximately 86 million more Americans have been diagnosed with "pre-diabetes", with most of those individuals likely to develop diabetes in the future.

As such, the financial analysts who focus on the pharmaceutical sector were all abuzz earlier this week as regards an announcement about a new medical study concerning Jardiance.

From an August 20, 2015 Forbes article, "Sweet Victory: Eli Lilly's Jardiance Is First Diabetes Drug To Reduce Heart Attacks And Strokes", by reporter Matthew Herper, we get a sense of that excitement:

A big win for Eli Lilly this morning. Its diabetes drug Jardiance, co-marketed with Boehringer Ingelheim,  is the first blood-sugar lowering pill ever to reduce the risk of heart attacks, strokes, and cardiovascular deaths in a big study, according to a press release issued this morning.

Of course, we need to wait to see full details from the study, not just the press release Lilly and Boehringer issued this morning....

And that Forbes article continued with some discussion about the diabetes drugs market share implications of this recent drug company announcement about Jardiance.

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We get some additional information about the significance this new Jardiance medical study from this Associated Press (AP) news report, "Diabetes drug may protect against heart attack, stroke":

... [T]he drug's two manufacturers - Eli Lilly and Co. of Indianapolis and German partner Boehringer Ingelheim GmbH - have announced only that a three-year study they conducted showed the drug delayed the time until patients died of cardiovascular disease or suffered a heart attack or stroke.

That brief summary, known as the top-line result, is meant to inform investors promptly that the closely watched study met its main goal, a result likely to affect Eli Lilly's financial prospects and stock price....

Dr. Ananda Basu, a diabetes specialist at the Mayo Clinic, cautioned that it's impossible to predict how patient treatment will be affected until details of the study design, the size of Jardiance's benefits and any side effects are disclosed.

The two drugmakers plan to release detailed findings at [the European Association for the Study of Diabetes on September 17] and simultaneously publish them in a medical journal.

However, despite this glory-moment for Eli Lilly and Boehringer, all is not well for Jardiance as well as the other SGLT-2 inhibitors such as Invokana and Farxiga.

This situation becomes apparent by the titles of these earlier articles:

Farxiga / Jardiance / Invokana Safety As Regards Diabetic Ketoacidosis Now Being Studied By Health Canada In Addition To Current FDA Investigation

Invokana / Farxiga / Jardiance: New Medical Study Finds A History Of Diabetic Ketoacidosis Events Is Associated With Increased Risk of Death

May 2015 Diabetes Drugs – Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible

Accordingly, referring back to the AP news report above, we are anxious to see the September 2015 medical journal article which will have more details about this recent Jardiance study, and possibly some discussion about the side-effects risks associated with Jardiance.

 

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Invokana Lawsuits Are Expected To Be Filed While FDA And Other Drug Regulators Investigate Side Effects Reports

Drug Injury Lawyers Also See Possible Farxiga And Jardiance Cases For Patients Who Have Ketoacidosis, Kidney Failure, Stroke, Or Heart Attack

 

(Posted by Tom Lamb at DrugInjuryWatch.com)
 

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UPDATE: "Health Canada Warns About Link Between DKA & Popular Diabetes Drugs"

(5/19/16)

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With there being a growing number of Type 2 diabetes patients in the US, it is not a surprise that the pharmaceutical companies are introducing new types of diabetes medications at an increasing rate to capture market share and make profits.

One new class of new diabetes medications are Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, which currently consist of these drugs:

Invokana (canagliflozin) -- first available in 2013
Invokamet (canagliflozin and metformin) -- first available in 2014
Farxiga (dapagliflozin) -- first available in 2014
Xigduo XR (dapagliflozin and metformin extended-release) -- first available in 2014
Jardiance (empagliflozin) -- first available in 2014
Glyxambi (empagliflozin and linagliptin) -- first available in 2015

As some of you know, often the serious side effects of new drugs are not recognized until after FDA approval and they are used by a larger patient population than was observed or studied in the earlier clinical trials.

And this seems to be the case with Invokana, Farxiga, Jardiance, and these other new diabetes drugs, as there are now numerous adverse event report which associate them with these side effects:

• Diabetic Ketoacidosis (DKA), Ketoacidosis, or Ketosis
• Heart Attacks / Myocardial Infarctions (MI)
• Ischemic Stroke / Cerebral Vascular Accident (CVA)
• Kidney Damage / Renal Failure
• Heart Failure

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And, in fact, reports of side effects related to Invokana, Farxiga, and Jardiance have gotten the attention of the FDA and other drug regulators, as can be seen by the following recent drug safety alerts:

“FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood” (May 15, 2015)

Review of diabetes medicines called SGLT2 inhibitors started — European Medicines Agency (June 12, 2015)

“Information Update – Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis” (June 22, 2015)

SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis — Medicines and Healthcare Products Regulatory Agency (June 26, 2015)

With these investigations by drug regulators there are, also, investigations by drug injury lawyers into possible lawsuits for people with Type-2 diabetes who used one of these SGLT2 diabetes drugs and developed ketoacidosis or kidney failure, as well as when these diabetics suffer a heart attack (MI), stroke (CVA), or heart failure.

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed any of the medical conditions listed above.

 

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

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Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity

In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action?

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a multiple myeloma drug. 

In more detail, from the Celgene Corporation Prescribing information for Pomalyst (accessed 6/3/15):

POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

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On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, "Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity", which stated:

A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports.

This May 2015 MHRA Drug Safety Update included this detailed information about each of these Pomalyst side effects:

Cardiac failure

The review concluded that this side effect is common (ie occurs in between 1/10 and 1/100 patients who take [Pomalyst (pomalidomide)]). In most cases, this side effect occurred in patients with cardiac disease or cardiac risk factors and within 6 months of starting [Pomalyst (pomalidomide)]. The review also concluded that [Pomalyst (pomalidomide)] can cause atrial fibrillation, which may precipitate cardiac failure.

Interstitial lung disease

[Pomalyst (pomalidomide)] can cause ILD and related events such as pneumonitis. The review concluded that this side effect is common (ie occurrs in between 1/10 and 1/100 patients who take pomalidomide). Onset of respiratory symptoms is usually within 6 months of starting treatment. However, there have been cases where ILD occurred approximately 18 months after starting [Pomalyst (pomalidomide)]. ILD usually resolves with steroid treatment and stopping [Pomalyst (pomalidomide)].

Hepatotoxicity

It is already known that [Pomalyst (pomalidomide)] can elevate alanine aminotransferase and bilirubin levels. The review found that [Pomalyst (pomalidomide)] can also cause serious hepatotoxicity, mainly acute hepatitis. Hepatitis was considered an uncommon side effect (ie occurrs in between 1/100 and 1/1,000 patients who take [Pomalyst (pomalidomide)]). There have also been reports of acute liver failure in patients receiving [Pomalyst (pomalidomide)]; however the review could not determine if [Pomalyst (pomalidomide)] caused the liver failure in these cases. The risk of serious hepatic events appears to be highest in the first 6 months of treatment, therefore regular liver function monitoring is recommended during this period. The available data do not provide sufficient evidence to support specific guidance on monitoring frequency.

We will continue to monitor the safety profile of Pomalyst (pomalidomide) including watching for any similar side effects warnings by the FDA.

 

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UK Drug Safety Regulator Issues New Warnings About The Use Of Depakote / Depacon / Depakene By Women During Pregnancy

Updates Information About Extent Of Serious Developmental Disorders Such As Autism Spectrum Disorders (ASD) As Well As Congenital Malformations And Birth Defects Like Spina Bifida

(Posted by Tom Lamb at DrugInjuryWatch.com)

Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) are manufactured and sold by the drug company AbbVie Inc. (formerly Abbott).

On January 22, 2015 the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Drug Safety Alert, "Medicines related to valproate: risk of abnormal pregnancy outcomes", which has to do with these drugs.  The subtitle of this MHRA warning was plain and clear:

• Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).

From the "Risk of abnormal pregnancy outcomes" section of that MHRA January 2015 warning:

Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination with other medicines. Data suggest that when valproate is taken for epilepsy with other medicines, the risk of abnormal pregnancy outcomes is greater than when valproate is taken alone.

The risk of congenital malformations is approximately 10% while studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking, and/or walking, have low intellectual abilities, poor language skills and memory problems.

Intelligence quotient (IQ) measured in a study of 6 years old children with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.

Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population. Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).

And from the "Future action" section of that MHRA January 2015 warning:

The product information will now be updated to reflect our current understanding of the available evidence and to make information as clear as possible.

For more details, one can read the January 2015 MHRA Dear Doctor Letter regarding valproate medicines such as Depakote / Depacon / Depakene.

In the US, back in May 2013 there was a so-called “Black-Box” warning and several other significant label revisions about serious risks for children whose mother used Depakote / Depacon / Depakene during pregnancy which were added to the Prescribing Information by FDA and the drug company AbbVie. In part those label changes concerned higher risks of neural tube defects like spina bifida, hypospadias, and other birth defects or congenital malformations.

Then in August 2014 the Prescribing Information, or drug labels, for Depakote / Depacon / Depakene were updated by the FDA and AbbVie Inc. to add a warning about the potential risk for autism spectrum disorders (ASD).

We will watch to see if there are any further Depakote / Depacon / Depakene label changes regarding autism and/or birth defects here in the US like those that are forthcoming in the UK, according the January 2015 Drug Safety Update regarding these valproate drugs.

For more about the safety issues concerning these drugs, see our Depakote / Depakene / Depacon drug information page.

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