Health Canada’s safety review of sodium-glucose cotransporter-2 (SGLT2) inhibitors — e.g., Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin) — concluded in July 2018 with the finding that there may be a link between the use of SGLT2 inhibitors and acute pancreatitis. However there was limited evidence to suggest a link with chronic pancreatitis. Health Canada is working with the manufacturers to update the Canadian product monographs, or drug labels, for SGLT2 inhibitors to include this increased risk of pancreatitis.
Viberzi Side Effects Like Pancreatitis Are Causing Injury And Deaths
Viberzi (eluxadoline) is approved for use in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Viberzi works by activating opioid receptors in the gut to decrease bowel contractions, which leads to less diarrhea. It can also help to ease stomach-area or abdomen pain and improve stool consistency.
In March 2017 this document was issued, “FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder”.
According to this March 2017 FDA document:
- Hospitalizations related to pancreatitis, including deaths, have been reported with Viberzi in patients who do not have a gallbladder.
- Hospitalizations related to pancreatitis have also been reported in patients with a gallbladder.
- Symptoms of pancreatitis can occur after just one or two doses of Viberzi.
In more detail, from the Data Summary part of this Viberzi FDA Drug Safety Communication:
From May 2015, when Viberzi was first approved, through February 2017, FDA received reports of 120 serious cases of pancreatitis or death in the FDA Adverse Event Reporting System (FAERS) database. Seventy-six of these cases resulted in hospitalization, of which two patients died….
As of February 2017, two deaths considered to be associated with Viberzi have been reported to FDA. Both deaths occurred in patients who did not have a gallbladder. One death was associated with pancreatitis and the other death was associated with sphincter of Oddi spasm. The case of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi. The case of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi. Both patients were hospitalized for treatment. Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose.
We are investigating possible Viberzi lawsuits against Allergan, the responsible drug company, for injury or death involving serious side effects such as pancreatitis and sphincter of Oddi spasm.
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No Warning Added By FDA To Drug Label For Actemra About Pancreatitis
An insightful article by reported Charles Piller, “Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients”, published June 5, 2017 online by STAT, put the spotlight on some serious but little-known side effects associated with this medicine from Genentech, Inc.
From that recent article we get this rather alarming safety information about Actemra:
… STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.
Most of those medications warn about these risks on their labels. Actemra does not.
Consumers are barraged every day with drug ads accompanied by numbing lists of side effects, but STAT’s investigation shows that the risks to patients might be greater than they are led to believe. The Food and Drug Administration has received reports on 1,128 people who died after taking Actemra, and has reviewed its safety several times since it was approved. But the agency doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths….
Experts who examined the data at STAT’s request said the FDA should immediately consider warnings for heart failure and pancreatitis — an inflammation of the pancreas that in its acute form can kill up to 50 percent of patients. They said the evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease, a sometimes-fatal scarring of lung tissue, is less convincing but warrants further review.
This focus on Actemra side effects and the lack of warnings about these adverse reactions shines the light on the apparent inadequate standards of post-marketing surveillance for drugs approved by the FDA.
We are interested in hearing about patients who were diagnosed with pancreatitis or some other serious side effect while using Actemra. You can do this by submitting a Quick Contact Form or by using the Email link found in the sidebar.
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Leukemia Drug Iclusig Had More Safety Warnings Added In November 2016
Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA.
In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. Also, there is a new part entitled Venous Thromboembolism which addresses venous occlusive events.
Under the Warnings and Precautions section of the Iclusig drug label there were some additional facts and new information put in the following pre-existing parts, which are presented the order in which they were set forth on the FDA CDER SLC page for Iclusig:
5.1 Arterial Occlusion
5.10 Hemorrhage
5.11 Fluid Retention
5.12 Cardiac Arrhythmias
5.13 Myelosuppression
5.14 Tumor Lysis Syndrome
5.17 Embryo-Fetal Toxicity
5.2 Venous Thromboembolism
5.3 Heart Failure
5.4 Hepatotoxicity
5.5 Hypertension
5.6 Pancreatitis
5.8 Neuropathy
5.9 Ocular Toxicity
Further, under Warnings and Precaution, there is this new part: 5.15 Reversible Posterior Leukoencephalopathy Syndrome (RPLS).
Iclusig (ponatinib) is a kinase inhibitor approved by the FDA as a treatment for certain types of leukemia in adult patients.
Finally as regards this limited Iclusig label changes overview, under the Adverse Reactions section of the Iclusig drug label there was some additional facts and new information put in this pre- existing part, 6.1 Clinical Trial Experience.
The complete set of new side effects warnings can be seen on the FDA’s Drug Safety Labeling Changes (SLC) page for Iclusig.
We will continue to monitor the safety profile of the leukemia drug Iclusig and to report significant future developments.
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